With approval to study the transcatheter replacement device in patients with severe tricuspid regurgitation, VDyne is advancing a treatment to compete with Edwards Lifesciences’ Evoque system.
Vantage’s intuitive three-step workflow, locate, dilate, decompress, enables physicians to perform procedures with consistency.
RALEIGH, N.C., April 2, 2026 /PRNewswire/ — Zeto, Inc., a medical technology company dedicated to making brain health insights through EEG a foundational vital sign in healthcare, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Zeto New Wave™, its newest EEG system for outpatient clinics and homes.
Lumitrace is currently approved in China and the US, with submission to EU regulatory authorities pending.
Restore Robotics announced new FDA 510(k) clearances for the remanufacturing of two Intuitive da Vinci Xi robotic surgical instruments.
Vdyne announced today that it received FDA investigational device exemption (IDE) for a pivotal trial evaluating its heart valve system.
Federal regulators on Wednesday approved Eli Lilly’s new weight-loss pill, a second daily oral medication to treat obesity and other weight-related conditions.
VASCADE MVP XL is now approved for larger sheaths used in market-leading PFA and LAAC technologies
Serenity Medical announced today that it received FDA Humanitarian Device Exemption (HDE) approval for its novel River stent.
MicroPort announced that it received FDA breakthrough device designation for its Apollo Dream sirolimus target-eluting stent system.