MedTech News

Tetrous Announces First Surgical Procedures Using EnFix Tac™ Demineralized Bone Fiber Implants to Enhance Enthesis Healing in Rotator Cuff Repair
LOS ANGELES, May 8, 2024 /PRNewswire/ — TETROUS, INC., a leading regenerative medicine company today announced that it has completed the first surgical cases using EnFix TAC™, its latest product that expands its line of EnFix™ implants to cover every surgical technique for rotator cuff repair.

4C Medical wins dual FDA breakthrough nods for mitral valve replacement device
4C Medical Technologies announced today that the FDA granted breakthrough device designation for its AltaValve system.

Outset Medical gets FDA nod for dialysis accessory months after halting sales
Outset paused shipments of its TabloCart with prefiltration last year after receiving a warning letter from the FDA.

ZygoFix Receives FDA Clearance for its zLOCK Lumbar Facet Fixation System
MISGAV, Israel, May 6, 2024 /PRNewswire/ — ZygoFix Ltd. a portfolio company of The Trendlines Group Ltd. (“Trendlines”) announced that it received regulatory clearance from the United States Food and Drug Administration (FDA clearance) for its zLOCK Lumbar Facet Fixation System. This achievement was supported by compelling clinical evidence from the company’s ongoing European clinical study, marking a significant advancement in spinal fusion technology..

Researchers develop gastrointestinal imaging capsule for esophagus surveillance and interventions
In an advancement in gastrointestinal health, researchers from Johns Hopkins University have developed the Multifunctional Ablative Gastrointestinal Imaging Capsule (MAGIC)—a gastrointestinal imaging capsule for esophagus surveillance and interventions.

Scientia Vascular Announces FDA approvals for New Line of Microfabricated Neurovascular Catheters
Scientia Vascular,is thrilled to announce the FDA clearance of two uniquely engineered catheters: the Plato 17 and the Socrates 38.

Medtronic renal denervation system wins approval in China
Medtronic (NYSE: MDT)+
today announced its Symplicity Spyral renal denervation system won National Medical Products Administration (NMPA) approval in China.

Owlet wins CE mark for Dream Sock infant monitoring tech
Owlet announced that it received CE mark approval for its Dream Sock device for monitoring the vital signs of infants.