1 min read
Veranex’s Model Assesses EXENT® GAM Assay* Savings in Myeloma Patient Monitoring
The investigational model considered the use of the EXENT® GAM Assay from the Binding Site, part of Thermo Fisher Scientific. This is a mass...
IVD
1 min read
Critical Updates for Medical Device Manufacturers and Healthcare Institutions: Switzerland Aligns with EU IVDR Transitions
Switzerland has officially implemented its adapted Ordinance on In Vitro Diagnostic Medical Devices (ODiV), effective January 1, 2025. This strategic...
4 min read
Optimizing PLM-OEM Collaborations: Key Strategies for a Smooth IVDR Transition
Under Directive 98/69/EC (IVDD), it was common practice for in vitro diagnostic medical devices to be placed on the European market under contractual...
3 min read
Exploring the Assay Development Pipeline for In-Vitro Diagnostics (IVDs)
Establishing a Strong Assay Foundation
1 min read
Playing Defense: Cybersecurity for Diagnostic Devices
No industry or device is immune from the risk of cyber attacks. And it’s especially important that medical devices including diagnostic instruments...
2 min read
Clinical Utility Evidence Planning: Framework, Assessment Techniques, and Case Study for a Diagnostic Test
Clinical utility describes the usefulness of a medical product (device, diagnostic/prognostic, or therapeutic) for physicians and/or patients, and...
4 min read
2024 IVDR Sprint: 6 Reasons Why You Should Start a Performance Evaluation Early
In 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...
2 min read
New Proposal for Extended Transition Periods for IVDs: Can Manufacturers Slow Down Transition Efforts?
On 23 January 2024, the EU Commission published a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to...
2 min read
How COVID Changed the Diagnostic Industry – for Better
It goes without saying that the pandemic has disrupted all aspects of our lives especially the healthcare system, including the diagnostic industry....
1 min read
Consumable vs. Instrument, the Creative Tension in Diagnostics Technology
By Juan F. Roman