Onkos Surgical this week announced it received FDA de novo approval for its antibacterial coated implants. According to the Parsippany, N.J.-based company, bacterial contamination of a permanent implant could have devastating effects in orthopedic oncology and revision arthroplasty. “Implant contamination is a growing concern to the orthopaedic surgical community,” Dr. Steven Gitelis, chief medical officer, […]
Food & Drug Administration (FDA)
Outset Medical stock soars on optimistic analyst outlook
Outset Medical shares are on the rise after BTIG analysts initiated coverage with a “Buy” rating for the home hemodialysis company. Shares of OM rose by more than 25% to $2.58 apiece in late-afternoon trading today. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose slightly. The optimistic outlook […]
Orthobond wins FDA de novo approval for antibacterial technology that could have vast device applications
Orthobond has secured FDA de novo approval for its Ostaguard antibacterial technology that could one day be used for a wide range of medical devices — and beyond medtech. The Monmouth Junction, New Jersey-based device developer says it’s the first time the FDA has granted a de novo request for a non-eluting coating designed to […]
FDA approves Symani surgical robot platform from Medical Microinstruments
Medical Microinstruments announced today that the FDA granted de novo clearance for its Symani surgical robot platform. Clearance covers soft tissue manipulation to perform microsurgery. This technique involves reconnecting tiny vessels to restore blood flow or redirect fluid during reconstruction or repair. FDA authorization makes Symani the only commercially available platform in the U.S. for […]
Neurovalens wins FDA nod for anxiety-treating neuromod device, raises $2.65M
Neurovalens announced today that it received FDA clearance for its Modius Stress device for treating anxiety and raised $2.65 million. Belfast, Northern Ireland–based Neurovalens designed Modius Stress to deliver non-invasive electrical stimulation. It stimulates key areas of the brain and nervous system without the need for surgically implanted electrodes. Modius Stress treats anxiety with a […]
Synchron launches BCI registry with eyes on larger study, approval
Synchron announced today that it launched a community-centered registry to evaluate its brain-computer interface (BCI) technology. The company said its study aims to bring patients, carers and clinicians together to learn about BCI design and its benefits for people with limited mobility. Synchron designed its BCI technology to decipher the neural code of the brain, […]
FDA says recall of Cerenovus catheter guide sheaths is serious
The FDA deemed a recall of catheter guide sheaths from Johnson & Johnson’s Cerenovus Class I, the most serious kind. Medos International Sàrl, a J&J unit, recalled the Cerenovus Cerebase DA guide sheath and single-use neurovascular guide catheter on Feb. 2, 2024. The company distributed the devices — 1,343 in total — between June 14, […]
FDA clears AngioDynamics’ AlphaVac F18 to treat pulmonary embolism
AngioDynamics this week announced it received FDA 510(k) clearance for its AlphaVac F18 system to treat pulmonary embolism (PE). The expanded FDA indication allows for the use of AlphaVac F18 system for the treatment of PE. The new indication expands the device’s use in the non-surgical removal of thrombi or emboli from the venous vasculature. […]
FDA clears new mammography system from Siemens Healthineers
Siemens Healthineers announced today that it received FDA 510(k) clearance for its MammoMat B.brilliant mammography platform. Clearance includes elements involving full-field digital mammography, or two-dimensional breast imaging, breast biopsy and titanium contrast-enhanced mammography. New features of the system enhance user ergonomics and workflow while reducing patient discomfort. Siemens Healthineers also submitted an FDA premarket approval […]
Haemonetics wins FDA clearance for hemostasis cartridge
Haemonetics announced today that it received FDA 510(k) clearance for its TEG 6s hemostasis analyzer system assay cartridge. The new cartridge extends Haemonetics’ TEG 6s viscoelastic testing capabilities. It can now serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings. Dr. Jan Hartmann, SVP and chief medical […]
InfuTronix has a Class I infusion pump recall
InfuTronix recently announced a voluntary recall of the Nimbus ambulatory infusion pump system from the U.S. market. Following the voluntary removal, the FDA deemed the recall Class I, the most serious kind. It affects 52,328 devices in the U.S. in total. The recall extends to the Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, […]