Veranex Blog
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How Policy is Driving Digital Health in Germany
Mar 25, 2025Several recent national-level policy changes highlight an accelerating digital transformation of healthcare in Germany, building on the Digital...
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NCCN 2021 Conference Highlights: Elevating Racial Equity in Cancer Care
Mar 25, 2025The National Comprehensive Cancer Network (NCCN) 2021 Annual Conference convened virtually March 18-20, drawing attendees from more than 40...
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Is China a 300 Million or 1.4 Billion Healthcare Population Market?
Mar 25, 2025A reflection on the 2019 capability development progress report of the county hospitals in China The Veranex (formerly Boston Healthcare Associates)...
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A Year in Review and Looking to the Future: Four Key Healthcare Megatrends
Mar 25, 20252020 has been a bit of a year, to say the least. It has also, though, been a year of invention, opportunity, and possibility for life science...
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MHRA Issues Guidance on New Medical Device Regulation in UK
Mar 25, 2025As a result of Brexit, the In Vitro Diagnostic Medical Device Regulations (IVDR) will not apply to Great Britain (England, Wales and Scotland)....
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Analysis of China’s First National Tender on Coronary Stents
Mar 25, 2025In previous newsletters (Aggressive National Programs To Drive Down Drug Costs, published in January 2019 and Medical Disposables & Consumables...
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Veranex Participates in the 3rd Annual Leaders in Life Sciences Breakfast Roundtable
Mar 25, 2025Eight leaders in Life Sciences came together for a virtual breakfast roundtable devoted to leading Life Sciences organizations through these...
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Veranex Partners with Alcon to Conduct Real-World Study Highlighting Efficiencies of Optical Biometer in Cataract Surgery
Mar 25, 2025Alcon, a global leader in eye care, collaborated with Veranex (formerly Boston Healthcare Associates) to conduct a Time-and-Motion Study to support...
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CMS Proposes Changes to Part B Medicare Reimbursement for Physician-Administered Drugs Approved Under the 505(b)(2) Approval Pathway
Mar 25, 2025The Centers for Medicare and Medicaid Services (CMS) intends to alter assignment of Healthcare Common Procedure Coding System (HCPCS) Level II codes...
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Webinar: Drug Delivery — Evaluating Off The Shelf and Novel Drug Delivery Solutions
Mar 25, 2025During this session, featured speaker Brandon Bogdalek, will interview three industry leading panelists. The panelists will discuss important...
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Webinar: Point-of-Care Diagnostics – Best Practices for Bringing Novel Solutions to Market
Mar 25, 2025In this webinar, featured speaker Brandon Bogdalek will interview three industry leading panelists in the diagnostics industry. The panelists will...
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Webinar: Digital Health – Embracing Human-Centered-Design to Create Impactful Digital Experiences
Mar 25, 2025In this webinar, featured speaker Brandon Bogdalek will interview Greg Silvesti from Sage Therapeutics. Brandon and Greg will discuss how to use...
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G-BA Specifies Procedures for Coverage with Evidence Development- Gene Therapy Zolgensma® First Case
Mar 25, 2025In Germany, the Federal Joint Committee (G-BA) recently amended its rules of assessment procedures to consider new therapies and products without...
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Medicare Clarifies Confusion Over Tests Covered by the NGS NCD
Mar 25, 2025The Medicare NGS NCD grants national coverage for somatic testing in patients with advanced cancer if the test has FDA-approval or -clearance as a...
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CMS New Technology Add-On Payment FY 2021 Proposed Rule
Mar 25, 2025The Centers for Medicare and Medicaid Services’ (CMS) New Technology Add-On Payment (NTAP) program is a system enacted by Congress and implemented...
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Centralized Risk Reporting, Escalation, and Governance (CRREG) Platform
Mar 25, 2025According to the most recent draft of the International Council on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6(R3), “The aim...
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Centralized Risk Reporting, Escalation, and Governance (CRREG) Platform
Mar 25, 2025According to the most recent draft of the International Council on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6(R3), “The aim...
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5 Tips When Designing Accessible Covid-19 Home Tests
Mar 25, 2025Veranex partnered with Rapid Acceleration of Diagnostics (RADx®) and the National Institute of Health (NIH) to help support the creation of a Best...
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ICER Quietly Moves to a Pure Digital Health Assessment
Mar 25, 2025In March, leaders from our health economics team, Tom Goss and Jordan Hinahara shared insights on health technology assessments in the US under the...
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EU Sets Benchmarks for Clinical Evidence Assessment for Recertification of Medical Devices
Mar 25, 2025As a result of the new European Union Medical Device Regulations (MDR), existing products (most legacy devices) that already had received CE Mark...
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DTx Part II: Building Evidence-Based Value Propositions for Digital Therapeutics
Mar 25, 2025In DTx Part I: Identifying Optimal Payment Models for Digital Therapeutics we identified several potential payment models for monetizing the value...
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DTx Part I: Identifying Optimal Payment Models for Digital Therapeutics
Mar 25, 2025According to the Digital Therapeutics Alliance (DTA), digital therapeutics (DTx) are products that deliver “software-generated therapeutic...
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An Overview of Digital Health in China
Mar 25, 2025We recently discussed the challenges and opportunities for diagnostic players amidst and post- the COVID-19 chaos in the context of China’s health...
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FDA Releases Final Guidance on Oncology Therapeutic Class Labeling of Companion Diagnostics
Mar 25, 2025April 2020 On April 13th, 2020, The Food and Drug Administration (FDA) published a final guidance entitled “Developing and Labeling In vitro...
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The VALID and VITAL Acts: What Do They Mean for Diagnostic Innovators?
Mar 25, 2025In early March, lawmakers in the U.S. House of Representative and U.S. Senate introduced the Verifying Accurate, Leading-edge IVCT Development ACT,...
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Preclinical Insights #37 – Prof. Alexandre Carpentier
Mar 25, 2025Veranex is proud to share the latest issue of our Preclinical Insights publication. In this issue we talk with Prof. Alexandre Carpentier about his...
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A Bird’s Eye View of the Nuclear Medicine and Radiopharmaceuticals Market in China
Mar 25, 2025Part 1: Providers and Regulators Getting information on the nuclear medicine market landscape, regulations, and market access environment in China...
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Navigating the Italian HTA Process: Essentials to a Favorable Review
Mar 25, 2025From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA (Agenzia Italiana del Farmaco) evaluated a total of 166 Dossiers – 28...
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German Draft Executive Order Provides Clarity for Reimbursement of Health Apps
Mar 25, 2025Towards the end of 2019, the German Federal Parliament introduced a simplified process for approval and reimbursement of digital health apps...
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ICER Set to Evaluate Non-Drug Products in 2020
Mar 25, 2025The Boston-based Institute for Clinical and Economic Review (ICER), an independent research organization that conducts health technology assessments...
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Germany Paves the Way for Reimbursement of Digital Health Care Apps
Mar 25, 2025In Germany, doctors could potentially be prescribing health apps as medicines as early as 2020. This is one of the main objectives of the draft bill...
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Possibility for Examination to be Included in the SHI Fee Scale Brings More Certainty for Reimbursement for New Diagnostics in Germany
Mar 25, 2025Manufacturers can now have more certainty about the process of inclusion of a new laboratory, new human-genetic, or new tumor-genetic diagnostics in...
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Escalated DRG Payment Model Pilot in China Expected to Pose a Genuine Threat to Innovators
Mar 25, 2025As a critical element of accelerating the healthcare payment reform, the pilot of Diagnosis Related Groups (DRGs) in 30 major cities across China...
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Event Recap: Biocompatibility Insights 2023
Mar 25, 2025We sat down with leaders from top life sciences companies to discuss foundational needs assessments – how to do them, what can go wrong when you...
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Opportunity Ahead in the Cardiovascular Devices Market
Mar 25, 2025Panel Recap: Industry experts share deep-level analysis at LSI Europe ’23
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Preclinical Insights #38 – What Sets Us Apart: Our In-House Pathology Department
Mar 25, 2025Veranex is proud to share the latest issue of our Preclinical Insights publication. In this issue we talk with Dr. Laurence Fiette, Head of...
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Preclinical Insights #39 — 25 Years of Preclinical Paris: A Conversation with Our Founders
Mar 25, 2025Preclinical Paris Founders Nicolas Borenstein and Luc Behr discuss their 25-year legacy.
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Preclinical Insights #40 — Have a Heart
Mar 25, 2025Preclinical Paris Founders Nicolas Borenstein and Luc Behr discuss their 25-year legacy.
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Deriving Value From Strategic Relationships and Tailored Solutions: Our Takeaways From PCT Summit – Amsterdam 2023
Mar 25, 2025The 19th Precision in Clinical Trials (PCT) Summit – Amsterdam brought together a wide range of representatives from the life sciences industry,...
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Celebrating Autism Awareness Month
Mar 25, 2025Susanah and Tucker, A Mother-Son Duo In 2016, Susannah Ashcroft drove home from an appointment at St. David’s Center for Child and Family...
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First Meeting of the Italian Regional Purchasing Centers
Mar 25, 2025Italian public healthcare structures can buy medical devices only via tenders. Up to 2016, competitive pricing was the main rule for tender winners....
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MedTech Pioneers – Digital Surgery 4.0 & The Power of Go, Go, Go
Mar 25, 2025Scott Huennekens CHAIRMAN OF THE BOARD, VIDA FLASH ACQUISITIONS, MEDTECH SPAC Scott Huennekens is one of the inspirations for this Medtech Pioneers...
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New Independent Medical Review Board for Germany
Mar 25, 2025For medical device and diagnostic innovators, a planned organizational change in review boards for Germany’s Statutory Health Insurance (SHI) could...
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MedTech Pioneers – Genesis MedTech Group: An Ascending Leader in Emerging Market MedTech Innovation
Mar 25, 2025Warren Wang, CHAIRMAN AND CHIEF EXECUTIVE OFFICER Tal Wenderow, VENTURE PARTNER Tal Wenderow and I connected at Life Science Intelligence’s Emerging...
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MedTech Pioneers – MedTech Innovator, The Largest Global MedTech Accelerator, From Inception To Scale
Mar 25, 2025Paul Grand CEO, MEDTECH INNOVATOR (MTI) I have had the pleasure of serving as a judge, advisor and mentor to Medtech Innovator over the past few...
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MedTech Pioneers – Intuitive Ventures: Convergent Technologies, Beyond the Robot, in Minimally Invasive Care
Mar 25, 2025Oliver Keown MD DIRECTOR, INTUITIVE VENTURES I met Oliver Keown MD, Director of Intuitive Ventures through Paul Grand’s Medtech Innovator ecosystem;...
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MedTech Pioneers – The Future of Digital Surgery at the Mayo Clinic
Mar 25, 2025Janani S. Reisenauer, MD GENERAL THORACIC SURGERY/INTERVENTIONAL PULMONARY MEDICINE, VICE CHAIR, INNOVATION, DEPARTMENT OF SURGERY Mark Wehde CHAIR,...
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Grounding Your Investment in Human-Centered Design With a Foundational Needs Assessment
Mar 25, 2025We sat down with leaders from top life sciences companies to discuss foundational needs assessments – how to do them, what can go wrong when you...
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Bridging Design and Manufacturing
Mar 25, 2025For growth-stage companies, finding a contract manufacturer to take on low volume runs and bridge the gap between design and manufacturing can be a...
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Meet the Team: Danita Harris, SVP and General Manager of Data Management and Analytics
Mar 25, 2025In this installment of our “Meet the Team” blog series, we talk to Danita Harris, Senior Vice President and General Manager of Data Management and...
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Medical Device Vigilance: Important Considerations to Comply With the EU MDR
Mar 25, 2025Vigilance reporting and postmarket surveillance of medical devices are among the many requirements documented in the EU MDR (2017/745) to ensure the...
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Meet the Team: Eric Matckie, SVP and GM of Commercial Strategy and Market Access
Mar 25, 2025In this installment of Meet the Team we’ll be getting to know Eric Matckie, the Senior Vice President and General Manager of Commercial Strategy and...
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Growth of the life sciences and medtech industry in India was apparent at BioAsia 2023
Mar 25, 2025A team from Veranex Data Management & Analytics recently traveled to Hyderabad, the capital of the Indian state of Telengana, for BioAsia 2023....
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Meet the Team: Sakthivel Sivam, Senior Director, Biostatistics
Mar 25, 2025In this installment of our “Meet the Team” blog series, we talk to Sakthivel Sivam, Senior Director, Biostatistics, about his industry experience,...
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Agile vs. Regulatory: How the Two Coexist and Contribute to Successful Medical Device Software Development
Mar 25, 2025Software is gaining relevancy in a broad range of medical devices, as it either enables the control or influence of their operation, or because...
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Insights Into the Needs of Chinese Hospital Lab Customers
Mar 25, 2025We recently analyzed a report prepared by Ding Xiang Yuan (abbreviated as DXY; Ding Xiang Yuan is one of the largest and most influential online...
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MedTech Pioneers – Promaxo: The Future of MRI Guided Diagnosis and Treatment
Mar 25, 2025Amit Vohra, PhD, MBA FOUNDER, CEO & PRESIDENT OF PROMAXO Dr. Amit Vohra is a visionary leader, serial entrepreneur, and technologist with a...
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MedTech Pioneers – Cala Health’s First-to-Market Bioelectronic Medicine for Hand Tremors
Mar 25, 2025Renee Ryan CEO, CALA HEALTH Renee Ryan, CEO of Cala Health, is a dynamic, active leader in our medtech community. Mike Neidert and I originally met...
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MedTech Pioneers – MedTech Innovation: Go Big and Bold in 2021
Mar 25, 2025Chris Velis FOUNDER & EXECUTIVE CHAIRMAN, MIRAKI INNOVATION Scott Pantel CEO of Life Science Intelligence & Emerging Medtech Summit Chris...
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MedTech Pioneers – MedTech Color: Bringing New Leaders Forward to Shape the Future of MedTech
Mar 25, 2025Kwame Ulmer Founder and Executive Director of MedTech Color Kwame Ulmer wears many hats in our medtech community; he serves as Principal at Ulmer...
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Celebrating Black History Month at Veranex
Mar 25, 2025Veranex is honored to celebrate our Black teammates today and everyday. Throughout February, we’re connecting with employees to learn more about...
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Basics of Drug Safety: Importance of Case Processing in Pharmacovigilance (PV)
Mar 25, 2025Case processing in pharmacovigilance is a fundamental activity to support safety surveillance in clinical trials. Along with an anticipated...
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Meet the Team: Aarekh Shrestha, Senior Manager, Drug Safety and Device Vigilance
Mar 25, 2025In this installment of our “Meet the Team” blog series, we talk to Aarekh Shrestha, Senior Manager, Drug Safety and Device Vigilance,...
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On Time and on Target – Challenges and 5 Tips from a Biometrics Contract Research Organization (CRO)
Mar 25, 2025It should come as no surprise that conducting a clinical trial is expensive. Just how expensive depends on the phase and design of the trial, with...
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Meet the Team: Jim Maciariello
Mar 25, 2025In this installment of our “Meet the Team” blog series, we talk to Jim Maciariello, General Manager of Product Design and Engineering (PD&E)....
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Addressing Inequity in Healthcare – A Case Study of Tackling Liver Cancer in New Zealand
Mar 25, 2025The following article illustrates how inequities arise in healthcare, one disease at a time. It highlights insights from a program we are currently...
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The New Normal for Market Access in China: Volume Based Procurement
Mar 25, 2025Our previous update1, Analysis of China’s First National Tender on Coronary Stents, discussed the first national-level centralized tender for a...
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MedTech Pioneers – Moray’s Robotic Trans-Catheter Mitral Repair System
Mar 25, 2025Co-founders: Mark Barrish BSME, JD, CEO and Phillip Laby, MSME, CTO Moray Medical, a Silicon Valley-based medtech startup, is developing a...
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MedTech Pioneers – Next Gen Robotic Wearable for Knee Osteoarthritis
Mar 25, 2025Roam Robotic’s Tim Swift, Founder, and CEO with Sujit Dike, VP Health San Francisco-based startup, Roam Robotics, is advancing robotic exoskeleton...
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MedTech Pioneers – MedTech Innovator’s 2020 Grand Prize Winner, Rhaeos
Mar 25, 2025Anna Lisa Somera Founder & CEO of Rhaeos, 2020 Grand Prize Winner of Medtech Innovator The largest global medtech-only accelerator, Medtech...
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5 Compelling Reasons to Go Functional Service Provider (FSP)
Mar 25, 2025Given the shifts that Contract Research Organizations (CROs) and the pharma industry have gone through with the COVID-19 pandemic and subsequent...
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Meet the Team: Meghana Kapoor, Manager, Clinical Data Management
Mar 25, 2025In this installment of our “Meet the Team” blog series, we talk to Meghana Kapoor, Manager, Clinical Data Management, about her background, her...
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Meet the Team: Soma Sekhar Koramatla, Associate Manager, Statistical Programming, Biometrics
Mar 25, 2025In this installment of our “Meet the Team” blog series, we talk to Soma Sekhar Koramatla, Associate Manager, Statistical Programming, Biometrics...
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Plan to Mitigate Challenges in Pharmacovigilance and Drug Safety
Mar 25, 2025Biopharmaceutical companies worldwide are developing better and most cost-effective medicines at an unprecedented rate. With billions of dollars...
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The Regulatory Constraints in Making Your LDT/CDx Partnership Choices in China
Mar 25, 2025Our previous blog discussed the emerging trends for the companion diagnostics (CDx) regulations in China. There have been several developments since...
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China Establishes a Regulatory Pathway for Companion Diagnostics
Mar 25, 2025The Chinese government has implemented a series of efforts to improve access to novel oncology therapies, one example of this is the significant...
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HHS Declares Emergency Use Authorization for Use of In Vitro Diagnostics for Detection of Monkeypox Virus
Mar 25, 2025WHAT DOES THIS MEAN? Monkeypox virus is a zoonotic infection, caused by Orthopoxvirus genus of the Poxviridae family like variola virus (the...
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Veranex Risk Based Monitoring Business Delivery Model – A Case Study
Mar 25, 2025Veranex has successfully designed and implemented a “5D Framework” to support its Risk Based Monitoring service delivery model. The 5 components...
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Veranex Risk Based Monitoring (RBM) Business Delivery Model With 5D Framework
Mar 25, 2025Veranex has successfully designed and implemented a “5D Framework” to support its RBM service delivery model, in order to create a better...
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MedTech Pioneers – Cleveland Clinic’s Mission to Advance Surgical Robotic Innovation
Mar 25, 2025Akhil Saklecha MD, Managing Director, Ventures Jihad Kaouk MD, Director, Center for Laparoscopic & Robotic Surgery, Cleveland Clinic A leader in...
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MedTech Pioneers – Dr. Maria Artunduaga Discusses Her Wearable Technology for Monitoring Lung Health and COPD
Mar 25, 2025Dr. Maria Artunduaga Founder and CEO of Respira Labs Dr. Maria Artunduaga is the founder and CEO of Respira Labs, a Mountain View-based startup with...
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MedTech Pioneers – Redesigning Healthcare Amidst a Pandemic
Mar 25, 2025Desert Horse-Grant and Dr. Jennifer McCaney, Co-Executive Directors, UCLA Biodesign This female dynamic duo founded UCLA’s Biodesign program in 2019...
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Understanding the ROI of Human Factors Engineering
Mar 25, 2025By Matt Gottschalk Designing a medical device or combination product requires immense expertise in risk management to ensure compliance and control...
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A Data Management Perspective: How Are Device Trials Different from Drug Trials?
Mar 25, 2025The many articles discussing the difference between drug and device trials are often coming from a regulatory perspective on how device trials are...
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Risk Based Monitoring & Technology Driven Solutions – Veranex Hosted Sponsor Visit at Bangalore, India Office
Mar 25, 2025Veranex is pleased to have hosted a key meeting with a Generics & Biosimilars Sponsor at the Bangalore, India office on May 31st, 2022. This...
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Meeting Early Phase Study Challenges – a Data Management Perspective
Mar 25, 2025First-in-Human studies are a discovery point, which can decide the fate of a compound as well as lay the groundwork for subsequent phases of a...
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How COVID Changed the Diagnostic Industry – for Better
Mar 25, 2025It goes without saying that the pandemic has disrupted all aspects of our lives especially the healthcare system, including the diagnostic industry....
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MedTech Pioneers – SV Health Investors Discuss the Firm’s New $90M Early-stage Medtech Convergence Fund
Mar 25, 2025Paul LaViolette Managing Partner & COO, SV Health Investors Forging where others are tentative to trod, SV Health Investors, in partnership with...
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Consideration and Challenges for Medical Device Database Builds
Mar 25, 2025How do regulatory requirements within the medical device industry impact a Database Build? What are the important items to be aware of? We will look...
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Automation and the Future of Clinical Data Management
Mar 25, 2025Automation in clinical data management (CDM) is becoming increasingly popular due to the increasing volume and complexity of data being generated by...
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August Image of the Month
Mar 25, 2025You be the Anatomist! To which species does this CT scan image belong?Answer: This is an image of an ovine (sheep)! Here’s how we know: The kidneys...
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September Image of the Month
Mar 25, 2025You be the Pathologist! What intervention caused the lesions shown in this ovine artery?Answer: Application of heat generated the collateral damage...
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October Image of the Month
Mar 25, 2025You be the Cardiac Imaging Specialist! What cardiac structures are observable on this IntraCardiac Echocardiography (ICE) image, and what approach...
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Medical Writing in Early Phase Studies
Mar 25, 2025Is specialized knowledge needed for Medical Writers working on early phase studies? Based on the characteristics and needs of Phase 1, 1a, 1b,...
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Looking Forward – AACC 2022 Round Up
Mar 25, 2025Only a few weeks until AACC 2022 in Chicago, the largest clinical diagnostics conference in the world. Ahead of the conference, I share some...
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Three Key Points to Prepare for an Early Phase Clinical Trial
Mar 25, 2025Companies preparing for an early phase study must deal with an array of challenges and decisions for biometrics, pharmacovigilance and regulatory...
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Biocompatibility of Medical Devices: Process, Detailed Steps and 7 Hot Topics to Crack the Code of Medical Device Safety
Mar 25, 2025Behind every successful medical device lies a crucial consideration that forms one of the cornerstones of its success: biocompatibility.
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Challenges for Medical Device Database Builds and Strategies to Overcome Them
Mar 25, 2025What are some of the challenges with database builds for medical device studies, given the current regulatory requirements? What are the important...
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November Image of the Month
Mar 25, 2025You be the Anatomist! To which species does this image of an aortic arch (red arrow) belong?Answer: This is an image of a human aortic arch! Here’s...
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China Reveals Its 2025 Coverage Goals for Publicly Funded Healthcare
Mar 25, 2025In September 2021, China’s National Healthcare Security Administration (NHSA), the government agent in charge of publicly funded healthcare...
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Plan to Mitigate Challenges in Pharmacovigilance and Drug Safety
Mar 25, 2025Biopharmaceutical companies worldwide are developing better and most cost-effective medicines at an unprecedented rate. With billions of dollars...
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China Payment Reform: 2020 Update
Mar 25, 2025The pilot of implementing a diagnosis related group (DRG) payment model to inpatient hospital care, a major initiative of China’s ongoing healthcare...
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China Aims to Complete Transition to DRG Payment Model for Inpatient Care by 2024
Mar 25, 2025In November 2021, the Chinese government announced its 3-year (2022-2024) payment reform plan with the end goal to fully implement a diagnosis...
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Escalated DRG Payment Model Pilot in China Expected to Pose a Genuine Threat to Innovators
Mar 25, 2025As a critical element of accelerating the healthcare payment reform, the pilot of Diagnosis Related Groups (DRGs) in 30 major cities across China...
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Provider and Patient Preference Studies: Demonstrating Product Demand for Drugs, Medical Devices, and Diagnostics
Mar 25, 2025Pharmaceutical manufacturers, medical device companies, and advanced diagnostic manufacturers are increasingly incorporating patients’ and...
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Selling the Science Is a Must to Secure Research Funding
Mar 25, 2025If you cannot sell the science, it is like it was not discovered (#provocativeoverstatement) “Gut science” became a thing during the last decade. I...
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Consumable vs. Instrument, the Creative Tension in Diagnostics Technology
Mar 25, 2025By Juan F. Roman You know how the diagnostics industry relies on the “razor blade” model: give the instrument for free and make the profit with the...
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Nanomaterials in Medical Devices: Biological Risks and Methodology for Biocompatibility Assessment
Mar 25, 2025Nanomaterials, due to their small size and high surface area, present distinctive physico-chemical properties. However, these properties also entail...
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Key Insights from NMPA Guidance Draft 01 & 02 from Our Human Factors Team
Mar 25, 2025The human factors team at Veranex has reviewed the NMPA Guidance Draft 01 and Draft 02 and submitted feedback to the agency. We're committed to...
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December Image of the Month
Mar 25, 2025You be the Pathologist! What type of implant is shown here, and in what location? Answer: This is a dental implant in the mandible! This mandibular...
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The Role of Scientific/Medical Literature Screening and Review in Pharmacovigilance
Mar 25, 2025Why search the scientific and medical literature? “Scientific and medical literature is a significant source of information for monitoring of the...
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New Proposal for Extended Transition Periods for IVDs: Can Manufacturers Slow Down Transition Efforts?
Mar 25, 2025The EU Commission recently published (January 23, 2024) a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming...
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Automation and the Future of Clinical Data Management
Mar 25, 2025Automation in clinical data management (CDM) is becoming increasingly popular due to the increasing volume and complexity of data being generated by...
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Implications of FDA’s Quality Management System Regulation (QMSR) Final Rule
Mar 25, 2025On February 2, 2024, the Food and Drug Administration (FDA) issued a final rule to amend the device current good manufacturing practice (CGMP)...
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2024 IVDR Sprint: 6 Reasons Why You Should Start a Performance Evaluation Early
Mar 25, 2025In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European...
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Amending Regulation for MDR / IVDR: Key Takeaways for the Diagnostics Industry
Mar 25, 2025Yesterday, the EU Parliament adopted the regulation amending EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring the...
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Artificial Intelligence (AI), General Data Protection Regulation (GDPR) and Cybersecurity: 10 Misconceptions About Medical Device Software
Mar 25, 2025Medical Device Software (MDSW) is a growing, fast-evolving industry. However, manufacturers must often face a regulatory framework which does not...
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Strategies for Successful Clinical Data Management Rescue Studies
Mar 25, 2025What is a rescue study? A rescue study is a clinical trial that is being conducted by a new vendor after having previously been conducted by another...
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Prioritizing Patient Safety and Fostering Innovation with the MHRAs New Roadmap for Medical Devices
Mar 25, 2025In January, the MHRA released a regulatory framework – Roadmap towards the future regulatory framework for medical devices. Learn more in this...
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Built to Fit Your Needs: Our CDMO Capabilities
Mar 25, 2025Learn about our capabilities and offerings as a CDMO We sat down with Bill Croisetiere (VP, Integrated Supply Chain), Chris Vigneau (VP,...
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Five Advantages of Veranex’s Quality Management Systems
Mar 25, 2025Our approach to Quality Management ensures that we’re always speaking the same language. When it comes to needing a Quality Management Solution,...
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The Power of Generative Artificial Intelligence in Medical Writing
Mar 25, 2025The use of artificial intelligence (AI) in clinical trials is evolving quickly. According to the research and consulting firm, Gartner, the life...
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Harnessing AI Technology to Identify Adverse Events with Great Accuracy and Efficiency
Mar 25, 2025The use of technology in clinical trials, including artificial intelligence (AI), is evolving rapidly. According to the consulting firm Gartner,...
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The Promise of Pulsed Field Ablation and the Critical Role of Preclinical Science in its Advancement
Mar 25, 2025CT Image of Pulmonary VeinsAtrial fibrillation remains a leading cause of death and disability and the most common type of arrhythmia. While...
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Avoid These Four Medical Device Supply Chain Woes
Mar 25, 2025Anyone who works in medtech product development knows that surprises are a guarantee. That’s why it’s important to create stability and...
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Risk Management in Pharmacovigilance
Mar 25, 2025It’s important to know that whenever a new medicinal product is authorized based on specified indications at the time of authorization, the benefits...
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Key Insights on the Challenges of Whitespace Innovation
Mar 25, 2025We recently sat down with three big-picture thinkers at Veranex to talk about whitespace innovation — its challenges, how we’ve seen it done...
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Document Review: A Nuanced Process in Medical Writing
Mar 25, 2025Veranex is determined to provide complete support to our healthcare partners to reach our shared goal of advancing medical care and improving...
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Appropriate, early planning for medical device development could help outshine the darkness of Alzheimer’s disease
Mar 25, 2025Exciting developments in the area of medical devices for the diagnosis, prognosis, treatment/management, and monitoring of Alzheimer’s disease (AD)...
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Clinical Utility Evidence Planning: Framework, Assessment Techniques, and Case Study for a Diagnostic Test
Mar 25, 2025Clinical utility describes the usefulness of a medical product (device, diagnostic/prognostic, or therapeutic) for physicians and/or patients, and...
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Building Blocks of Quality: The Role of Design Control in Medical Device Development
Mar 25, 2025Design Control is a critical quality management system process that allows for a concept be developed and evolve into a reliable and safe product...
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Playing Defense: Cybersecurity for Diagnostic Devices
Mar 25, 2025No industry or device is immune from the risk of cyber attacks. And it’s especially important that medical devices including diagnostic instruments...
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Achieving Regulatory Clearance for a Novel Device – Provisio Medical
Mar 25, 2025Provisio™ SLT IVUS™ System Creating a novel medical device typically includes innovation around treatment, capabilities, cost reduction, or...
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Ensuring Compliance with New FDA Guidance on Software Documentation & Cybersecurity
Mar 25, 2025New guidance from the FDA replaces similar, but now obsolete, guidance. Some of the guidance was issued in response to the PATCH Act, which is a...
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Expert Insights: Project Management with Matt Perry
Mar 25, 2025Matt PerryVP of program management at VeranexRecently we sat down with Matt Perry, VP of program management at Veranex, to talk about common project...
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Leveraging AI and ML in Medical Products – Part 1
Mar 25, 2025Bob BouthillierDirector, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence...
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How Confounding Forces Impact Medical Device Development
Mar 25, 2025Bob Bouthillier Director, Electrical Engineering, Veranex We live in a time where we have easy access to biometrics that help both our clinicians...
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Leveraging AI and ML in Medical Products – Part 2
Mar 25, 2025Bob BouthillierDirector, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence...
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Leveraging AI and ML in Medical Products – Part 3
Mar 25, 2025Bob Bouthillier Director, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence...
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What is Fast to Proof-of-Concept?
Mar 25, 2025We see a continued need from our clients, both large and small, to partner with organizations that can deliver meaningful and actionable solutions...
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How to Design an Efficient Preclinical Testing Study
Mar 25, 2025A medical device's pathway from concept to commercialization can be fraught with pitfalls, setbacks, and a need to recurring, significant...
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Scope of Statistical Applications in Risk-Based Quality Management (RBQM)
Mar 25, 2025Risk-based quality management (RBQM) represents a core area of clinical development that systematically focuses on both safety and data quality...
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Identification, Engagement and Commitment of Key Players for a Successful Preclinical Study
Mar 25, 2025Assembling a team for an efficient preclinical studyWhen it comes to kicking off your preclinical study, assembling the right team will help you...
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Critical Elements of High-Quality Preclinical Study Protocols
Mar 25, 2025When a medical product innovator has reached the point at which preclinical research is necessary to achieve the next milestone, they have already...
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Common Costs in Preclinical Testing Programs
Mar 25, 2025All preclinical study estimates are not created equal and they can get expensive. Medical device innovators need to know what goes into the making...
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Best Practices: Preparing for a Patent
Mar 25, 2025Bob BouthillierDirector, Electrical Engineering, VeranexIn this post, our director of electrical engineering Bob Bouthillier covers the importance...
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5 Keys to Successful Partnerships: Building Stronger Collaborations to Support Medtech and Pharma
Mar 25, 2025Successful business partnerships within the life sciences industry are often the cornerstone of thriving drug development. Here are five essential...
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Exploring the Assay Development Pipeline for In-Vitro Diagnostics (IVDs)
Mar 25, 2025Establishing a Strong Assay Foundation Before we can conceptualize IVD product configurations, we must establish assay inputs which include, but are...
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Tackling Postpartum Hemorrhage: Innovations on the Horizon
Mar 25, 2025Postpartum hemorrhage (PPH) remains a significant global health concern as the leading cause of maternal mortality worldwide. According to the World...
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Ten Things to Know Before You Start Your GLP Study
Mar 25, 2025The most expensive study is one you have to repeat Good laboratory practice (GLP) studies are an essential component to medical product development...
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The Ins and Outs of Using ECMO and VAD in Preclinical Studies
Mar 25, 2025ECMO Vs. VAD Ventricular assist device (VAD) and extracorporeal membrane oxygenation (ECMO) are two similar temporary techniques to bridge cardiac...
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How 3D Printing Can Accelerate Your Product Development Timeline
Mar 25, 2025Accelerate Your Product Development Timeline One of the biggest timeline impacts in any development program is getting the product to work. Our...
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What Makes a Good Preclinical Study Final Report?
Mar 25, 2025When it comes to meeting deadlines and continuing to receive investments, the timely review of your GLP preclinical final report is very important....
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Reducing the 90% Recurrence Rate for Glioblastoma Treatment Through an Implantable Device for the Delivery of Stem Cells
Mar 25, 2025Extending Patient Lifespan with LifeSTEM What is Glioblastoma? Gliomas are brain tumors that come in multiple forms ranging from low-grade, benign...
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Giving Back
Mar 25, 2025Nicolas Borenstein, DVM, Ph.D. Co-President, Preclinical Services “We are not a veterinary clinic and our primary mission is indeed to validate...
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On-Site State-of-the-Art CT Scanner Adds Capability, Efficiency, and Cost Savings for Preclinical Clients
Mar 25, 2025Image credit: Clinical Imaging Systems Did you know that our Atlanta-based preclinical lab is home to a GE LightSpeed VCT 64 Slice CT Scanner with...
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Challenges for Medical Device Database Builds
Mar 25, 2025How do regulatory requirements within the medical device industry impact a database build? What are the important items to be aware of? In this...
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Optimizing PLM-OEM Collaborations: Key Strategies for a Smooth IVDR Transition
Mar 25, 2025Under Directive 98/69/EC (IVDD), it was common practice for in vitro diagnostic medical devices to be placed on the European market under...
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Five Questions to Ask When Selecting a CRO for Preclinical Studies
Mar 25, 2025Medical device innovators need trustworthy CROs for preclinical studies to help speed the process from concept to commercialization Below are a few...
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Testing Medical Devices with Artificial Anatomy Models
Mar 25, 2025Whether you’re a new medtech startups or established strategic, testing new devices against realistic anatomical conditions is crucial for success....
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From Reactive to Predictive: The Unseen Architecture of Modern Risk Management
Mar 25, 2025How Clinical Teams Are Replacing Firefighting With Future-Proof Monitoring The Silent Efficiency Leak: Why Legacy Systems Fail In 2024, a study of...
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Critical Updates for Medical Device Manufacturers and Healthcare Institutions: Switzerland Aligns with EU IVDR Transitions
Mar 25, 2025Switzerland has officially implemented its adapted Ordinance on In Vitro Diagnostic Medical Devices (ODiV), effective January 1, 2025. This...
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Navigating FDA’s Latest Guidance Updates for AI-Enabled Medical Devices: A Marketing Submission Guide
Mar 25, 2025As artificial intelligence transforms healthcare innovation, the FDA continues to evolve its regulatory framework for AI-enabled device software...
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AI Medical Devices: Your Comprehensive Guide to Development and Documentation
Mar 25, 2025The integration of artificial intelligence into medical devices represents a transformative shift in healthcare technology. Yet, for manufacturers...
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Rescue Studies: Salvaging Clinical Trials Through Expert Data Management
Mar 25, 2025When a clinical trial faces data quality challenges, every day counts. Rescue studies have become an increasingly critical component in preserving...
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Advanced CT Imaging in Preclinical Research: Pioneering Tomorrow’s Cardiovascular Innovations Today
Mar 25, 2025The evolution of medical device testing demands increasingly sophisticated imaging capabilities. At Veranex, our state-of-the-art CT scanning...
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AI Medical Devices: Answering Your Burning Questions
Mar 25, 2025As artificial intelligence continues to revolutionize medical device development, the FDA's evolving regulatory framework presents both...
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Medical Device Innovation: A Doctor’s Journey to Transforming Respiratory Care
Mar 25, 2025Maria Artunduaga, MD, MPH, MTM Founder and CEO of Samay In This Podcast: How and why Dr. Artunduaga created her company The challenges she faced...