CardioFocus today said it appointed Stephan Ogilvie as chief financial officer. Prior to joining the Marlborough, Mass.-based company, Ogilvie served as managing director of healthcare investment banking at B Riley Securities. He has also served as VP of corporate development at Nuvasive and has held numerous leadership roles at ThinkEquity Partners, Lazard Capital Markets and Medtronic. […]
ZygoFix today said it received CE mark approval for its minimally invasive screwless spinal fusion system. The Israel-based company designed its zLock spinal fusion system to treat chronic back pain. ZygoFix’s zLock system has a miniature 3D-printed implant that uses the spine’s anatomy for spinal stability instead of a traditional external screw-based stabilization. The company […]
Oticon Medical today said the FDA has granted premarket approval for the company’s Neuro Cochlear Implant System. Somerset, N.J.-based Oticon Medical designed the Neuro system to treat people 18 years or older with bilateral severe-to-profound sensorineural hearing loss and who have limited benefits from fitted hearing aids. “At Oticon Medical, we are passionate about using […]
Penumbra (NYSE:PEN) today said its Red 62 reperfusion catheter has received FDA 510(k) clearance. Alameda, Calif.-based Penumbra designed the catheter to navigate complex distal vessel anatomy and deliver powerful aspiration with its Penumbra Engine to remove blood clots in acute ischemic stroke patients with large vessel occlusions. Get the full story on our sister site, Medical […]
CardioFocus today said its HeartLight X3 catheter ablation technology received approval from the Japanese Ministry of Health, Labor and Welfare. Marlborough, Mass.-based CardioFocus designed the catheter ablation technology for controlled and consistent pulmonary vein isolation to treat atrial fibrillation (AFib). Get the full story on our sister site, Medical Tubing + Extrusion.
BD (NYSE:BDX) today said it has received FDA 510(k) clearance for its PeritX peritoneal catheter system. Franklin Lakes, N.J.-based BD designed the catheter system to drain symptomatic, recurrent non-malignant ascites, which causes a build-up of fluid in the abdomen. Get the full story on our sister site, Medical Tubing + Extrusion.
Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology. The Parsippany, N.J.–based company designed BioGrip to address the clinical challenge of aseptic loosening in musculoskeletal oncology and complex orthopedic limb salvage surgery. It helps provide bone ingrowth at the bone-implant interface. Get the full story on our sister […]
Avania today said it has acquired medical device clinical research outfit IMARC for an undisclosed amount. Strongsville, Ohio–based IMARC is a full-service clinical research oversight company that offers monitoring, auditing, safety, data management and training. Get the full story on our sister site, Medical Design & Outsourcing.
Cleerly today said it has launched its digital care software for heart attack prevention following a $43 million Series B funding round. New York–based Cleerly’s digital care technology is a non-invasive coronary computed tomography angiography that performs coronary artery phenotyping through artificial intelligence. According to the company, it uses millions of annotated lab images to […]
Spinologics’s Spino Modulation today announced that it received FDA breakthrough device designation for its MIScoli vertebral body tethering device. Spino Modulation designed the system to treat scoliosis in young adolescents. Vertebral body tethering (VBT) is a less invasive alternative to spine fusion, which is the standard of care for adolescents who need surgery to correct […]
Glaukos (NYSE:GKOS) recently announced that it received regulatory approval from Australia’s Therapeutic Goods Administration for its Preserflo MicroShunt. The San Clemente, Calif.–based company designed the MicroShunt to reduce intraocular pressure in the eyes of patients who have primary open-angle glaucoma where IOP remains uncontrollable or where glaucoma progression needs surgery. Get the full story on our […]