The Shape Sensing Co. is seeking investors to fund the productization and FDA clearance of its fiber optic sensor technology for surgical navigation. Austin, Texas-based TSSC wants to raise $10 million in the Series B round, CEO Ryan DeBoer said in an interview with MassDevice. That should be enough for two-and-a-half years of runway, enough […]
FDA
Raydiant Oximetry wins FDA IDE nod for fetal pulse oximeter
Raydiant Oximetry announced that the FDA granted investigational device exemption (IDE) to its Lumerah technology. IDE enables an early feasibility study evaluating the technology for pregnant women during labor and delivery. The company designed Lumerah to improve the detection of fetal distress during labor and delivery. A non-invasive, transabdominal fetal pulse oximeter, it measures the […]
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 […]
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 […]
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 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, […]
Onward submits movement-restoring spinal cord stim tech to FDA
Onward Medical announced today that it submitted a de novo application to the FDA for the approval of its ARC-EX spinal cord stimulation system. The Eindhoven, the Netherlands-based company designed ARC-EX to restore function of upper extremities after spinal cord injury (SCI). If approved, the company says ARC-EX would become the first ever SCS therapy […]