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Functional MR Added To FDA-Approved Indication For Abbott's MitraClip

 
• By Reed Miller

The new indication covers functional mitral regurgitation, also known as secondary mitral regurgitation, which represents two-to-three times as many patients as the primary mitral regurgitation population MitraClip is already labeled for. The approval is supported by results from the COAPT trial, the first randomized trial to show that a mitral-valve repair could improve outcomes in patients with secondary mitral regurgitation.

Vascular-Mitraclip
• Source: Abbott Laboratories, Inc.

US FDA approved Abbott Laboratories Inc.'s MitraClip transcatheter mitral valve repair system for select heart failure patients with clinically significant secondary, or functional, mitral regurgitation based on results of the COAPT trial, the company and agency announced March 14.

The approval came several months faster than Abbott predicted. During Abbott’s presentation at the Barclays Global Healthcare Conference in Miami...

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More from Approvals

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
• By Natasha Barrow

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By Elizabeth Orr

The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.

New Treatment For Chronic Facial Pain Could Launch By Fall 2025

 
• By Elizabeth Orr

NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.

More from Policy & Regulation

Global Medtech Guidance Tracker: May 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

More Haste Less Pace? Challenging The ‘Early As Possible’ Principle In Medtech Innovation

 
• By Stuart Grant

The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?

Guardant’s Multi-Cancer Detection Test Granted FDA Breakthrough Device Designation

 
• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.