MedTech News
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.
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.
MCRA Supports Darmiyan with FDA Approval for BrainSee Device
WASHINGTON, May 2, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in the successful granting of Darmiyan’s De Novo request for BrainSee by the U.S. Food and Drug Administration (FDA).
BMF receives FDA 510(k) clearance for UltraThineer cosmetic veneer material
Zirconia materials now qualified for use in the production of the world’s thinnest cosmetic veneers.
Penumbra launches Lightning Flash 2.0 CAVT technology designed to rapidly remove blood clots
Lightning Flash 2.0 features advanced computer assisted vacuum thrombectomy (CAVT) software, designed for increased efficiency and sensitivity to enhance removal of venous thrombus and treatment of pulmonary emboli (PE)
Olympus launches digital video monitor for single-use endoscopes
Olympus this week announced it launched the DVM-B2 Digital Video Monitor for single-use endoscopes.