Medical Device and Diagnostic Industry (MD+DI)

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

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...
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 ...
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 ...
RAPS

FDA Confirms it Won't Regulate Apps or Devices Which Store Patient Data

The US Food and Drug Administration (FDA) has put the finishing touches on a new policy which explains how it plans to regulate medical devices, including mobile apps, which track patient data and ...
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 ...
Medical Device Network on MSN

ProSomnus secures FDA clearance for RPMO2 device

RPMO₂ features a fully embedded oximeter over maxillary dentition, using buccal vestibule mucosa behind the upper lip.
FierceBiotech

FDA formally kicks off medical device user fee negotiations

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...
STAT

Many medical devices deemed ‘breakthrough’ by FDA are backed by patchy evidence

Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can ...
Medical Device and Diagnostic Industry (MD+DI)

User Fees Drive Most of the CDRH Increase in FDA’s Budget Request

FDA has released its budget request for fiscal year 2027, which would provide the agency’s Center for Devices and ...