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News We’re Watching: Senators Call For Recall Info, TriClip Gets Panel Date

 
• By Brian Bossetta and Elizabeth Orr

This week, US Senators Dick Durbin and Richard Blumenthal asked a government watchdog to review the FDA’s device recall authority; the FDA announced a panel date for Abbott’s MitraClip; and the DermaSensor skin cancer detection tool got FDA authorization.

Regulatory News We're Watching
• Source: Shutterstock

Citing reporting from the Pittsburgh Post-Gazette and ProPublica, US senators Dick Durbin, D-IL, and Richard Blumenthal, D-CT, are calling for the Government Accountability Office (GAO) to review the FDA’s oversight of medical device recalls.

The senators reference news reports that say Philips Respironics failed to submit timely and comprehensive adverse event reports on his...

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More from Regulation

New EU Rules Limit Chinese Participation In Medtech Procurement

 
• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 
• By Amanda Maxwell

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

More from News We're Watching

News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

 
• By Brian Bossetta, Marion Webb, Elizabeth Orr, and Natasha Barrow

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

News We’re Watching: New OPEQ Head, Constructive Bio Funding Round, Natera Wins Injunction In Patent Suit

 
• By Natasha Barrow, Brian Bossetta, Elizabeth Orr, and Marion Webb

This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.

News We’re Watching: Neuralink’s Blindsight Gets FDA Breakthrough Device Tag; FDA Pump Recalls, Guidances; Discure, DeepLook Bolster Coffers

 
• By Marion Webb, Brian Bossetta, Elizabeth Orr, and Natasha Barrow

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.