MedTech News

Valcare Medical Receives FDA Approval to Initiate Early Feasibility Study for its Novel AMEND™ Trans-Septal System
HERZLIYA, Israel and WILMINGTON, Del., March 13, 2025 /PRNewswire/ — Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the AMEND™ Trans-Septal System for investigational device exemption (IDE) application to commence an Early Feasibility Study (EFS).

Vave Health Introduces World’s First Wireless, Handheld, Whole-Body Ultrasound with a Single PZT Transducer
SAN JOSE, Calif., March 13, 2025 /PRNewswire/ — Vave Health proudly announces the launch of its Universal Wireless Probe. This simple, innovative device is designed to enhance efficiency, accuracy, and diagnostics in a variety of clinical and educational settings. Its combination of linear and phased imaging technology provides high quality, full-body imaging with no ongoing subscription fees or hidden costs.

Vivani reports first human GLP-1 implant for weight loss in adults
Vivani Medical (Nasdaq:VANI) announced today that it successfully administered the first GLP-1 implant in its LIBERATE-1 clinical trial.

Johnson & Johnson MedTech wins FDA nod for enhanced robotic-assisted bronchoscopy
Johnson & Johnson MedTech (NYSE: JNJ)+
announced today that the FDA cleared its Monarch Quest technology for robotic-assisted bronchoscopy.

Robotics and spinal stimulation restore movement in paralysis
Spinal cord injuries are life-altering, often leaving individuals with severe mobility impairments. While rehabilitation robotics—devices that guide movement during therapy—have improved training for those with spinal cord injuries, their effectiveness remains limited. Without active muscle engagement, robotic-assisted movement alone does not sufficiently retrain the nervous system.

Elute Earns U.S. FDA Clearance for Its Novel Synthetic Resorbable Bone Void Filler
SALT LAKE CITY, March 12, 2025 /PRNewswire/ — For the thousands of patients in the United States requiring treatment for bone loss or defects caused by trauma or infections, Elute, Inc., a clinical stage company and emerging leader with a groundbreaking controlled and extended drug delivery platform, proudly announces U.S. Food and Drug Administration (FDA) approval of BonVie+™, a novel bone void filler implant.

Stryker launches next-gen Mako suite
Stryker (NYSE: SYK) announced today that it is commercially launching the next generation of its Mako surgical robotic platform.

Sooma wins FDA IDE for neuromod tech that treats depression
Sooma Medical announced today that it received FDA investigational device exemption (IDE) for its transcranial direct current stimulation (tDCS) device.