The FDA issued a notice deeming a recall of Medtronic [WtwhTicker symbol="MDT"](NYSE: MDT)[/WtwhTicker] McGrath Mac video laryngoscopes Class I, the most serious kind. This recall involves removing certain devices from where they are used or sold as the device may cause serious injury or death if people continue using it. It also includes … [Read more...] about Medtronic recalls McGrath Mac laryngoscope due to potential for explosions
Regulatory
Olympus’ Odin Medical wins FDA nod for first cloud-based AI endoscopy system for colonoscopy
Olympus announced today that its Odin Medical unit received FDA 510(k) clearance for its Caddie computer-aided detection (CADe) device. The cloud-based AI technology assists gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures. Olympus says its the first cloud-based AI technology for this purpose. It could … [Read more...] about Olympus’ Odin Medical wins FDA nod for first cloud-based AI endoscopy system for colonoscopy
FDA grants IDE for Jupiter Endovascular’s pulmonary embolectomy system
Jupiter Endovascular announced today that the FDA approved an investigational device exemption (IDE) study for its Vertex system. The company can now conduct the SPIRARE II U.S. pivotal study for the pulmonary embolectomy system. Menlo Park, California-based Jupiter Endovascular only just came out of stealth mode, spinning out of Neptune Medical … [Read more...] about FDA grants IDE for Jupiter Endovascular’s pulmonary embolectomy system
Renata Medical wins FDA nod for first-of-its-kind stent for young children
Renata Medical today said the FDA approved its first-of-its-kind Minima growth stent tailored for neonates, infants and young children. Newport Beach, California-based Renata designed the stent to re-expand over the course of the child’s growth period. The company says its approval marks a “groundbreaking advancement” in care for young children … [Read more...] about Renata Medical wins FDA nod for first-of-its-kind stent for young children
CereVasc wins FDA breakthrough nod for eShunt system
CereVasc announced today that it received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH). The company said data generated during pilot clinical studies of the device supported the breakthrough device designation. This designation enables priority review and enhanced communication with … [Read more...] about CereVasc wins FDA breakthrough nod for eShunt system
Obvius Robotics earns FDA breakthrough nod for central venous catheterization access system
Obvius Robotics announced today that the FDA granted breakthrough device designation for its Certa access system for central venous catheterization (CVC). CVC procedures require access to one of the great veins (internal jugular, subclavian, or femoral) to place a multi-lumen catheter for rapid replacement of blood volume, administration of … [Read more...] about Obvius Robotics earns FDA breakthrough nod for central venous catheterization access system
FDA clears Siemens Healthineers’ AI-powered cardiovascular ultrasound and catheter
Siemens Healthineers announced today that it received FDA clearance for its Acuson Origin ultrasound system and AcuNav Lumos 4D ICE catheter. Acuson Origin, a new, dedicated cardiovascular ultrasound, includes AI-powered features. It can help physicians perform cardiac procedures more efficiently in the areas of diagnostics, structural heart … [Read more...] about FDA clears Siemens Healthineers’ AI-powered cardiovascular ultrasound and catheter
Pentax wins FDA nod for duodenoscope with new sterilization tech
Pentax Medical announced today that the FDA cleared its DEC duodenoscope compatibility with the Sterrad 100NX sterilizer. Advanced Sterilization Products (ASP) develops Sterrad as its flagship product. Together, the companies aim to address the ongoing challenges of duodenoscope reprocessing. They hope to reduce the risk of cross-contamination … [Read more...] about Pentax wins FDA nod for duodenoscope with new sterilization tech
Teleflex wins FDA clearance for perfusion balloon for PTCA
Teleflex (NYSE: TFX) announced today that the FDA has granted 510(k) clearance for the company's Ringer perfusion balloon catheter for percutaneous transluminal coronary angioplasty (PTCA). The clearance expands Wayne, Pennsylvania–based Teleflex's interventional cardiology portfolio. It enables the company to offer what it says is the only … [Read more...] about Teleflex wins FDA clearance for perfusion balloon for PTCA
Imperative Care wins FDA nod for stroke catheter
Imperative Care announced today that the FDA granted 510(k) clearance for its Zoom 6F insert catheters for ischemic stroke procedures. The company also announced the successful completion of the first case with the Zoom 6F insert catheters. Dr. Dana Tomalty performed the case at Huntsville Hospital in Huntsville, Alabama. Tomalty used the … [Read more...] about Imperative Care wins FDA nod for stroke catheter
