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, […]
Food & Drug Administration (FDA)
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, […]
Olympus wins FDA clearance for its first single-use flexible ureteroscope
Olympus announced today that the FDA granted 510(k) clearance for its RenaFlex single-use ureteroscope system. The company expects to begin a full-market rollout at a later date. RenaFlex offers access and visualization in the urinary tract to diagnose and treat urinary diseases and disorders, such as kidney stones. It helps visualize organs, cavities and canals […]
Tandem Mobi automated insulin pump wins FDA nod for expanded pediatric use
Tandem Diabetes Care (Nasdaq:TNDM) announced that the FDA cleared its Mobi insulin pump for an expanded pediatric indication. The FDA approved Tandem’s 510(k) application for the use of Mobi in individuals two years of age and older. In an SEC filing dated April 1, the company said the decision came through on March 21. Previously, […]
FDA clears Baxter Novum IQ large-volume infusion pump, Dose IQ safety software
Baxter (NYSE:BAX) announced today that the FDA granted 510(k) clearance for its Novum IQ large-volume infusion pump (LVP) with Dose IQ safety software. Clearance adds the LVP to the Novum IQ platform, which already includes the Baxter syringe infusion pump (SYR). It enables clinicians to utilize a single, integrated system across a variety of patient […]
FDA clears sleep monitoring software from Beacon Biosignals
Beacon Biosignals announced that it received FDA 510(k) clearance for its SleepStageML machine-learning software for sleep monitoring. SleepStageML automatically stages sleep from electroencephalogram (EEG) signals of clinical polysomnography (PSG) recordings. It aids in the diagnosis and evaluation of sleep and sleep-related disorders. Boston-based Beacon Biosignals said in a news release that the software could enable […]
Neuralink may be getting some scrutiny on Capitol Hill
Reuters reports that U.S. Rep. Earl Blumenauer (D-OR) issued a letter to the FDA questioning its inspection practices related to Neuralink. The report said Blumenauer asked why the FDA decided not to investigate the Elon Musk-backed brain chip maker before allowing in-human trials. This relates to repeated questions around animal practices at the company. Reuters […]
Synaptive Medical wins FDA nod for near-infrared fluorescence in robotic exoscope
Synaptive Medical announced today that it received FDA 510(k) clearance for its near-infrared fluoresence visualization module on its robotic exoscope. The Toronto-based company can now add its Modus IR module to the existing fluorescence offering on the 4K, 3D Modus X system. Modus IR bolsters the capabilities of the exoscope across all neurosurgical procedures, as […]