JD Supra

Addressing Data Integrity Challenges in Medical Device Submissions

Cathy Burgess, Benjamin Wolf, Jong Ho "Philip" Won, Ph.D. The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...
Becker's Hospital Review

FDA loosens data rules for select medical device submissions

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...
Fierce Healthcare

CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday ...
JD Supra

CMS and FDA Announce RAPID Coverage Pathway to Accelerate Medicare Coverage for Breakthrough Medical Devices

Faster Medicare Coverage. The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration ...
MD&M East

FDA’s AI Device Regulations: Key Updates & Compliance Strategies for Medtech Success

FDA has moved artificial intelligence (AI) in medical devices from an exploratory concept to operational expectations, finalizing a pathway to pre-approved algorithm updates (PCCPs), publishing ...
FierceBiotech

FDA opens door to massive real-world datasets in medical device submissions

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...
MD&M East

FDA Outlines AI Medical Device Software Recommendations in Draft Guidance

On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...
The American Journal of Managed Care

FDA to Accept Deidentified Real-World Evidence for Select Medical Device Applications

The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...
Fox Business

FDA rolls back 'red tape' in move aligned with Trump push to speed up new cures

Echoing President Donald Trump’s call to accelerate medical innovation, Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency will no longer block companies from ...
Becker's Hospital Review

8 Recently Issued FDA Device-Related Guidelines

In the second quarter of 2014, the U.S. Food and Drug Administration has issued eight draft and final guidance documents related to medical device manufacturers and marketers. Compiled by The National ...
Morning Overview on MSN

FDA clears first US trial of Motif’s wireless brain implant for depression

A coin-sized device with no battery, no wires, and no deep surgical penetration into the brain just cleared its biggest regulatory hurdle. In late April 2026, the FDA granted Motif Neurotech an ...
Hosted on MSN

FDA approves first TAVR device for severe aortic regurgitation

The FDA has granted pre-market approval to JenaValve’s Trilogy system, the first transcatheter aortic valve replacement (TAVR) device in the U.S. specifically indicated for severe aortic regurgitation ...