Forbes

FDA Medical Device Cybersecurity And SBOMs: Compliance And Potential

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
Forbes

FDA Medical Device Security SBOMs: While Great, Don’t Rely On Them Alone

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...
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FDA Outlines AI Medical Device Software Recommendations in Draft Guidance

On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”).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

FDA floats new draft guidance, created by international group, on software as a medical device

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...
Medical Device Network

FDA clears Philips’ AI interventional cardiology assistance software

Philips’ DeviceGuide uses AI to track and visualise mitral valve replacement devices during mitral regurgitation procedures.
Dark Reading

FDA's Critical Role in Keeping Medical Devices Secure

The Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...
MobiHealthNews

Commentary: Why FDA’s software precertification program may be bad for business

So through the adoption of this program FDA hopes to raise the Culture of Quality and Organizational Excellence at medical device software companies. That’s part of what FDA gets out of this, and ...
Healthcare Dive

The number of AI medical devices has spiked in the past decade

The number of medical devices with artificial intelligence technology has risen sharply in the past decade. The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices ...