Gary Keeler

1 min read

German Draft Executive Order Provides Clarity for Reimbursement of Health Apps

Towards the end of 2019, the German Federal Parliament introduced a simplified process for approval and reimbursement of digital health apps prescribed to patients covered under the statutory health insurance (SHI). This brings opportunities for...

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1 min read

ICER Set to Evaluate Non-Drug Products in 2020

The Boston-based Institute for Clinical and Economic Review (ICER), an independent research organization that conducts health technology assessments...

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1 min read

Possibility for Examination to be Included in the SHI Fee Scale Brings More Certainty for Reimbursement for New Diagnostics in Germany

Manufacturers 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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2 min read

First Meeting of the Italian Regional Purchasing Centers

Italian 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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4 min read

Deriving Value From Strategic Relationships and Tailored Solutions: Our Takeaways From PCT Summit – Amsterdam 2023

The 19th Precision in Clinical Trials (PCT) Summit – Amsterdam brought together a wide range of representatives from the life sciences industry, from...

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1 min read

New Independent Medical Review Board for Germany

For medical device and diagnostic innovators, a planned organizational change in review boards for Germany’s Statutory Health Insurance (SHI) could...

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5 min read

Medical Device Vigilance: Important Considerations to Comply With the EU MDR

Vigilance 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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3 min read

Insights Into the Needs of Chinese Hospital Lab Customers

We 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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3 min read

Agile vs. Regulatory: How the Two Coexist and Contribute to Successful Medical Device Software Development

Software 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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5 min read

MedTech Pioneers – MedTech Color: Bringing New Leaders Forward to Shape the Future of MedTech

Kwame 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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