Roivios announced today that it received FDA breakthrough device designation for its JuxtaFlow renal assist device (RAD). The Bahamas-based medical device company designed JuxtaFlow to improve treatments for patients facing kidney disease during cardiac surgery. JuxtaFlow uses a unique, gentle negative pressure technique on the kidneys’ urine-collecting system. It enhances function and shield against hypoxia-induced […]
FDA
FDA approves Medtronic’s Inceptiv closed-loop rechargeable spinal cord stimulator
Medtronic announced today that it received FDA approval for the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS) system. Inceptiv treats chronic pain and represents Medtronic’s first SCS device to offer a closed-loop feature. This feature senses each person’s unique biological signals, adjusting stimulation moment-to-moment as needed. Medtronic says that keeps therapy in harmony with the […]
Philips receives FDA warning letter over imaging systems manufactured in China
The FDA published a warning letter that it sent to Philips that outlines issues around imaging technology manufacturing practices. During an inspection of a manufacturing facility in Suzhou, China, the FDA determined that the devices are “adultered.” The inspection took place from Oct. 23, 2023, through Oct. 26, 2023. Philips received the letter outlining violations […]
FDA says InfuTronix infusion pump recall includes 1 death
The FDA today shared new information on an infusion pump recall from InfuTronix that included one report of death. Following a voluntary removal, the FDA deemed the recall Class I, the most serious kind, earlier this month. It affects 52,328 devices in the U.S. in total. Today, the agency shared that a slew of issues […]
FDA wants to advance health equity through home-based care
The FDA has announced an initiative to reimagine the home environment as an integral part of the healthcare system and promote health equity for all Americans. The new initiative, called “Home as a Health Care Hub,” seeks to address the longstanding disparities in healthcare access and outcomes using home-based care. FDA’s Center for Devices and […]
Blue Arbor wins FDA breakthrough nod for neuromuscular interface
Blue Arbor Technologies announced today that it received FDA breakthrough device designation for its Restore neuromuscular interface system. The FDA also accepted the system into its Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread […]
FDA clears Epitel remote monitoring tech, AI detection platform
Epitel announced today that it received FDA 510(k) clearance for two new patient-focused brain health offerings. The FDA cleared the Remi remote EEG monitoring system for ambulatory use and the Remi Vigilenz AI for event detection. Remi for ambulatory use allows for EEG recording in outpatient and home environments for an extended duration. Vigilenz AI […]
TSSC seeks funding to get fiber optic sensor tech across the finish line
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 […]
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 […]