1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

Commission Decision Launches Pediatric And Rare Disease Expert Group

 
• By Amanda Maxwell

A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.

Dermal Fillers For Décolletage May Gain FDA Approval

 
• By Elizabeth Orr

An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 
• By Brian Bossetta

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 
• By Amanda Maxwell

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

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.