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Neovasc Plans Next Steps After Thumbs Down From FDA Panel

 
• By Elizabeth Orr

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.

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More from United States

Migraine Relief Without A Pill: Click’s FDA Cleared CT-132 Turns Smartphone Into Therapy Tool

 
• By Shubham Singh

Built on Click’s AI-enabled platform, CT-132 delivers a 12-week behavioral intervention program rooted in multiple evidence-based techniques, including cognitive behavioral therapy (CBT) and bio-behavioral approaches. The goal: reduce brain hypersensitivity and enhance patients’ resilience to migraine triggers.

OneCell Diagnostics – Now 1Cell.Ai - Launches Multi-Modal Cancer Diagnostic Panel OncoIncytes

 
• By Natasha Barrow

OneCell Diagnostics, the Mumbai-based startup backed with $16m in series A funding, is rebranding to 1Cell.Ai to represent the firm's focus on combining deep science with AI-powered capabilities.

Makary Proposes Combined Adverse Event Reporting Systems In Megyn Kelly Interview

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement

 
• By Elizabeth Orr

The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.

More from North America

Trump’s Preliminary 2026 HHS Budget Plan Protects US FDA User Fee Collection

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

Congress has launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

Looking Back Towards The Future

 
• By Brian Bossetta

As it celebrates 75 years shaping the medtech industry, Medtronic invited Medtech Insight to its Minneapolis headquarters to get a closer look at the company’s past, what it’s working on now, and what’s on the horizon.