News

STAT4h
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
STAT7d
Many medical devices deemed ‘breakthrough’ by FDA are backed by patchy evidence
The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.
Modern Engineering Marvels on MSN4d
How AI, Misinformation, and Regulatory Gaps Collide in the Kennedy Health Era
Is AI the solution to America’s glacial drug approval process, or a Pandora’s box for public health? That’s the question ...
MassDevice6d
Olympus to address FDA concerns over Japan manufacturing that led to import alerts
Olympus announced recently that it is committed to addressing the concerns of the FDA around its device manufacturing in ...
pharmaphorum7d
Four things you need to know about FDA regulations and digital health
While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency. In fact, the FDA’s definition of a ...
Healthcare Dive7d
FDA stops Olympus devices from entering the US
The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System ...
MassDevice12d
FDA wants to prevent import of certain Olympus scopes manufactured in Japan
The FDA is notifying healthcare providers about import alerts for certain medical devices manufactured in Japan by Olympus.
MedTech Dive7d
Olympus pledges prompt response following FDA import block
Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...
The Regulatory Review9d
A New Era of Cosmetics Safety Regulation
Federal authority to regulate cosmetics remained largely unchanged until, on December 29, 2022, President Biden signed the ...
DataBreachToday10d
FDA Expands Premarket Medical Device Cyber Guidance
The Food and Drug Administration has published final guidance for the cybersecurity of premarket medical devices. The new ...
HealthcareInfoSecurity12d
FDA Urges Medical Product Makers to Beef Up OT Security
The Food and Drug Administration is urging medical product makers to carefully address the cybersecurity of their connected ...
Becker's Hospital Review10d
FDA blocks entry of Olympus devices over safety concerns
The FDA has barred the import of multiple medical devices manufactured by Olympus Medical Systems and its subsidiaries in Japan, citing ongoing violations of federal quality system regulations.