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 ...
On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous ...
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 ...
On Monday, February 2, a new final rule from FDA changing QMS requirements for medical devices went into effect. Manufacturers have had over two years to comply with the new rule, which is now full ...
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 ...
Want a tested and safety-compliant at-home health tech? Check out our favorite FDA-cleared red light therapy devices of 2026.
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