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US FDA's Gottlieb Takes Digital Device Questions From Senators At Cures Hearing

 
• By David Filmore

The commissioner explained to senators he is trying to go beyond the 21st Century Cures Act to further encourage development of innovative digital devices.

US FDA Commissioner Scott Gottlieb emphasized to Senators Dec. 7 the agency's goal to "go beyond" health-software provisions in the 21st Century Cures Act to allow FDA to exclude from regulation most digital devices and clinical decision software. Gottlieb testified before the Senate Health, Education, Labor and Pensions (HELP) Committee on the same day the agency issued three guidance documents that build on its initiative to streamline digital-health oversight.

Portions of the Medical Electronic Data Technology Enhancement for Consumer's Health Act (MEDTECH Act), originally sponsored by Sens. Michael Bennet, D-Colo., and Orrin Hatch, R-Utah, were ultimately made part of the Cures Act. One draft guidance document issued Dec

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• By Elizabeth Orr

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Dexcom Puts Stelo On Amazon, Setting Up Consumer Showdown With Abbott

 
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Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
• By Amanda Maxwell

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GE HealthCare Warns Of $500M Tariff Hit In 2025, Eyes Recovery in 2026

 
• By Shubham Singh

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Peerbridge Bets On At-Home Heart Monitoring With Rechargeable, Longer-Lasting ECG Patch

 
• By Marion Webb

Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.