This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
icotec, known for developing implantable devices using its BlackArmor® Engineered Carbon/PEEK material, has received clearance from the U.S. Food and Drug Administration for the CMORE® CT System. ...
MedCAD has received 510(k) clearance from the U.S. Food and Drug Administration for its AccuStride™ fixation plates, completing the company’s customised foot and ankle surgical system. ...
RevBio has received approval from the U.S. Food and Drug Administration to begin a pilot clinical study of TETRANITE, a regenerative bone adhesive intended to support the repair of complex wrist fractures. ...
SpectraWAVE, Inc., has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its X1™-FFR product. ...
Becton, Dickinson and Company (BD) has introduced the BD Incada™ Connected Care Platform, an AI-enabled, cloud-based system that unifies data from BD devices into a single intelligent ecosystem. ...
Hyperion Surgical, Inc. has completed the world’s first robotic-assisted intravenous (IV) catheterisation using its Ivy™ robotic vascular access platform. ...
Bunkerhill Health has received approval from the U.S. Food and Drug Administration (FDA) for Bunkerhill MAC, an artificial intelligence (AI) tool designed to detect and measure mitral annular calcification (MAC)....
CAPS Medical, a clinical-stage MedTech company, has received Breakthrough Device Designation from the U.S. FDA for its PlasmaSure™ System, aimed at treating low- to intermediate-risk non-muscle...
Biolinq Incorporated has received De Novo Classification from the US Food and Drug Administration (FDA) for its lead product, Biolinq Shine™, marking a major regulatory milestone for the company....
Plexāā, a medical technology company focused on improving surgical outcomes, has announced the U.S. launch of its BLOOM43 platform, coinciding with Breast Cancer Awareness Month. The platform combines a wearable preconditioning device and a companion app to help patients prepare for breast surgery....