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Medmarc Blog (blog.medmarc.com)

FDA Guidance on AI Medical Devices: Predetermined Change Control Plans

September 25, 2025

One of the challenges regulators face with AI-enabled medical devices is that they are not static products. Unlike a traditional implant or diagnostic tool, the device that receives FDA approval may...

Patients, Manufacturers Plead for Medicare Breakthrough Device Coverage

September 24, 2025

A group of 67 patient groups and life science organizations has petitioned the Centers for Medicare & Medicaid Services for coverage of breakthrough medical devices. The request comes at a time when...

AdvaMed Celebrating 50 Years

September 23, 2025

AdvaMed, the MedTech Association, is celebrating its 50th anniversary in 2025. For five decades, AdvaMed has championed innovation, policy, and advocacy on behalf of the medical technology...

12 Essential Things - Product Liability Insurance Coverage

August 19, 2025

Here are 12 essential things that life sciences clients should have included with their product liability insurance coverage, based exclusively on insights from Medmarc: Tailored Coverage for...

FDA, Device Makers in Negotiations For Next User Fee Agreement

August 15, 2025

The FDA and the medical device industry are officially in negotiations for the sixth medical device user fee agreement (MDUFA VI), negotiations which are taking place as fees under the current...

H.R. 1 Restores Deductibility of Research and Development Expenses

July 25, 2025

Both chambers of the U.S. Congress have passed House Resolution 1 (H.R. 1), which offers several significant tax benefits for companies in the life sciences industry. One of the most important of...

FDA Unveils Voucher Program for High Priority Therapeutic Products

June 26, 2025

The FDA has established a new priority review program for premarket applications for pharmaceuticals that reflects the agency’s health priorities. Under this program, the premarket review process...

AdvaMed Supportive of Three Bills for the MedTech Industry

June 04, 2025

Three bills have been introduced to Congress that may improve the prospects for manufacturers of medical devices, two of which would improve the outlook for the entire industry. The Advanced Medical...

AdvaMed Presses Senate on Urgency of Tariff Relief for Medical Devices

May 21, 2025

Tariffs placed on medical devices could impede patient access to these lifesaving products, an argument made by Scott Whitaker, President and CEO of the Advanced Medical Technology Association...

AdvaMed AI Roadmap Prods Washington to Keep Pace

May 12, 2025

The Advanced Medical Technology Association (AdvaMed) has published a policy roadmap for artificial intelligence (AI), identifying the tremendous benefits AI has to offer patients. However, AdvaMed...