Neovasc Plans Next Steps After Thumbs Down From FDA Panel

FDA advisory committee members said the trial population was too small and homogenous and did not establish that Neovasc’s Reducer effectively treats angina.

Human heart. 3d illustration.

Canadian device firm Neovasc Inc. is still pondering its next steps after a US Food and Drug Administration advisory panel declined to endorse the company’s Reducer to treat angina in certain patients earlier this week.

More from United States

Democrats Condemn Trump’s HHS Layoffs During House Hearing On OTC Drug User Fees

 

Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.

Regulatory Experts Alarmed By Credible April Fool’s About US Targeting EU Notified Bodies

 

A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.

US Could Lose Its First Approver Advantage After FDA Layoffs

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

Staff Cuts At CDRH Focus On Administrative Workers, Spare Reviewers

 

About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.

More from North America

Abbott’s TriClip Reduces Severity Of Tricuspid Regurgitation Two-Year Results Confirm

 

Abbott presented late-breaking data at the 2025 American College of Cardiology conference demonstrating that TriClip transcatheter edge-to-edge repair offers prolonged patient benefits compared to medical treatment alone after two years, which were not evident at one year.

Exact Sciences Launches Cologuard Plus

 

The Cologuard Plus test has a sensitivity of 95% and a specificity of 94% for the detection of colorectal cancer; “unmatched accuracy,” according to Exact Sciences.

First At-Home Test For Multiple STIs Gets FDA Clearance

 
• By 

The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.