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 wins Japan regulatory approval for HeartLight X3 system
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 home peritoneal catheter system wins expanded FDA clearance
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 wins FDA clearance for BioGrip 3D-printed implant
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 acquires IMARC
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 launches digital heart attack prevention software following $43M Series B
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 […]
Spino Modulation vertebral body tethering device wins FDA breakthrough device designation
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 wins Australian regulatory approval for MicroShunt
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 […]
Hologic completes $795M Mobidiag acquisition
Hologic (NSDQ:HOLX) today announced that it has completed its $795 million acquisition of diagnostic developer Mobidiag Oy. France-based Mobidiag develops PCR-based tests for acute care conditions, including gastrointestinal and respiratory infections, antimicrobial resistance management and healthcare-associated infections. Its Amplidiag and Novodiag platforms can deliver results in 50 minutes to two hours. Marlborough, Mass.-based Hologic announced the […]
FDA approves Stratatech’s StrataGraft skin graft
Mallinckrodt‘s (NYSE: MNK) Stratatech today received FDA approval for its StrataGraft for treating adult patients with thermal burns. The Bedminister, N.J.-based company designed StrataGraft to treat thermal burns that have intact dermal elements, or remaining deep skin layers, for which surgical intervention is clinically indicated. “Serious burns can be an incredibly difficult injury to treat and can […]
How Abbott engineered a catheter-delivered device for premature babies
Abbott’s experience designing its Piccolo device provides essential lessons for medical device creators who want to spark a pediatric medical device renaissance. The Amplatzer Piccolo occluder from Abbott is one of the first medical devices that health providers can implant in premature babies weighing as little as 2 lb to treat patent ductus arteriosus (PDA) […]
