medical device

BioCardia secured FDA alignment on two regulatory routes for its Helix transendocardial delivery catheter, with the agency backing simultaneous approval with CardiAMP cell therapy.

Stryker completes acquisition of Boston-based Amplitude Vascular Systems, adding next-generation intravascular lithotripsy technology to peripheral vascular offerings.

Glucotrack submits IDE application for FDA clinical trial of implantable continuous glucose monitoring technology, marking major regulatory milestone for diabetes care innovation.

IceCure Medical showcased ProSense® cryoablation at breast surgeons conference, reporting 30%+ Q1 revenue growth as adoption accelerates.

Pulse Biosciences reported Q1 2025 net losses amid clinical expansion, with $119.3M cash and three devices progressing toward commercialization milestones.

Aclarion appoints Daniel Keefe as Western U.S. Commercial Director to accelerate adoption of its Nociscan diagnostic platform amid triple-digit growth.

$ADGM surges 11.92% after FULCRUM-VT trial shows 84% shock freedom, 59% arrhythmia freedom, supporting FDA Premarket Approval pathway for vCLAS ablation system.

FDA classifies Class I recall for Tandem Diabetes' Mobi insulin pumps due to false motor failure detection risking insulin delivery interruption.

Senseonics launches Eversense 365 implantable glucose monitor in Europe with one-year lifespan. Q4 revenue surged 72% year-over-year to $14.3 million.

Picard Medical to showcase Emperor Total Artificial Heart at ISHLT 2026 conference, advancing next-generation mechanical circulatory support for end-stage heart failure patients.

STAAR Surgical surges 20% after-hours on $90M Q1 sales, more than double year-ago quarter, driven by China and Americas growth despite regional headwinds.

Aethlon Medical's Hemopurifier device advances to final clinical trial phase following positive safety review with no adverse events reported.

LENSAR ends merger with Alcon due to FTC regulatory hurdles. Company retains $10M deposit, refocuses on independent growth strategy for robotic cataract laser system.

Senseonics reports real-world data from 5,059 Eversense 365 CGM users showing 93.8% wear time and strong glucose control metrics over one year.

Picard Medical's SynCardia Systems showcases its Total Artificial Heart technology on FOX Business, highlighting over 2,100 implants worldwide.

Beyond Air ($XAIR) will present at the 38th Annual Roth Conference in March, showcasing its nitric oxide therapy platform for respiratory and oncology applications.

IceCure Medical will report 2025 full-year results March 17, 2026, before market open, with a conference call at 11:00 a.m. EDT.

TransMedics surges 104% on organ transplant dominance and 32% growth, but 56x forward earnings premium and 25% short interest raise sustainability questions for 2026.

Catheter Precision ($VTAK) will showcase its FDA-approved LockeT suture retention device at ISLAA 2026, demonstrating cost-saving wound closure technology to electrophysiology fellows.

IceCure's ProSense cryoablation achieved 92.9% volume reduction in independent breast fibroadenoma study, validating technology for a 63,000-patient annual U.S. market.