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 […]
Food & Drug Administration (FDA)
Medtronic wins expanded FDA approval for cryoablation catheters
Medtronic (NYSE:MDT) announced today that it received FDA expanded approval for its Arctic Front family of cardiac cryoablation catheters. Fridley, Minn.–based Medtronic’s Arctic Front family of catheters treat recurrent symptomatic paroxysmal atrial fibrillation (AFib) as an alternative to antiarrhythmic drug (AAD) therapy as an initial rhythm control strategy. Get the full story at our sister site, […]
FDA clears Masimo wearable thermometer for prescription, OTC use
Masimo (NSDQ:MASI) announced today that it received FDA 510(k) clearance for two uses of its Radius Tº wearable thermometer. Irvine, Calif.–based Masimo clearances for Radius Tº cover both prescription use and over-the-counter use for patients and consumers 5 and older, according to a news release. Radius Tº includes continuously trending temperature measurements and Bluetooth connectivity […]
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 […]
Smiths Medical recalls some insulin syringes over skewed graduation marking
Smiths Medical announced today that it issued recall notices for its Jelco Hypodermic Needle-Pro fixed needle insulin syringes. Minneapolis-based Smiths Medical became aware of specific models and lots of the Jelco Hypodermic Needle-Pro fixed needle syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. The company identified markings skewed upward […]
Unraveling aducanumab’s impact remains a challenge
The FDA’s conditional approval of Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Alzheimer’s drug aducanumab (Aduhelm) may have been controversial, but the decision will likely have a significant financial impact. There are 6 million people with Alzheimer’s in the U.S. alone, according to Alzheimer’s Association estimates. Approximately half of those patients have mild symptoms, which is the group most likely […]
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 […]
VoluMetrix’s venous waveform monitor wins FDA breakthrough designation
VoluMetrix announced today that it received FDA breakthrough device designation for its NIVA HF venous waveform monitor. Nashville, Tenn.–based VoluMetrix designed the investigational NIVA HF device to monitor the venous waveform, a novel physiologic signal in heart failure patients, through its non-invasive venous waveform analysis (NIVA) technology. According to a news release, a fast-track grant […]
Former FDA commissioner Hahn to join VC behind Moderna
Flagship Pioneering announced that former FDA commissioner Dr. Stephen Hahn will lead its Preemptive Medicine & Health Security initiative. A “bioinnovation platform company,” Flagship Pioneering has originated and fostered more than 100 scientific ventures totaling more than $90 billion in aggregate value, according to the company. Get the full story at our sister site, Drug […]
FDA rejects Verily’s smartwatch-based Parkinson’s exam
The FDA issued a letter to Google’s (NSDQ:GOOGL) Verily declaring that it will not accept a letter of intent for the company’s Parkinson’s exam. Verily submitted the LOI for drug development tool (DDT) for the virtual motor exam for Parkinson’s disease. The device measures a change in digitally assessed parameters of a subset of Parkinson’s disease […]
J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant
Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out. The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination. Get the full […]
