Better Therapeutics (Nasdaq:BTTX) announced today that the FDA granted breakthrough device designation for its MASH treatment. The company’s prescription digital therapeutic (PDT) delivers novel cognitive behavioral therapy (CBT). It aims to treat adults with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH. This novel form of CBT targets the lifestyle behaviors known to cause and/or […]
Food & Drug Administration (FDA)
EnsoData wins FDA nod for AI sleep diagnosis tech using pulse oximeters
EnsoData announced today that it received FDA 510(k) clearance for technology that enables AI-powered sleep diagnosis using pulse oximetry devices. Powered by the company’s EnsoSleep PPG scoring, widely available, wearable, FDA-cleared pulse oximetry technology can be used for sleep diagnosis, according to EnsoData. The company says it enables a high-quality, accessible and cost-effective approach to […]
FDA clears wearable EP monitoring patch from X-trodes
X-trodes announced today that it received FDA 510(k) clearance for a new wireless wearable technology for electrophysiological (EP) monitoring. The Herzliya, Israel-based company calls its solution “Smart Skin,” although it plans to market it in the U.S. as the X-trodes System M. Smart Skin features a customizable, dry-printed, multi-modal electrode patches. It monitors a wide […]
High-ranking official in FDA’s CDRH plans to retire
Dr. William Maisel, Director of the Office of Product Evaluation and Quality (OPEQ) for the FDA Center for Devices and Radiological Health (CDRH) plans to retire this year. MedTech Dive first reported the news on Feb. 15. An FDA spokesperson confirmed Maisel’s planned retirement via email. He spent more than 14 years with CDRH, including […]
FDA clears surgical guidance system from Merit Medical
Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA 510(k) clearance for the Scout MD surgical guidance system. Scout MD broadens the South Jordan, Utah–based company’s oncology portfolio. Merit designed the system to enhance the diagnosis and treatment of breast cancer, as well as other soft tissue cancers. The system includes the Scout radar […]
FDA clears first over-the-counter fingertip pulse oximeter from Masimo
Masimo announced today that it received FDA clearance for its MightySat Medical over-the-counter fingertip pulse oximeter. The company says that the regulatory nod makes MightySat Medical the first and only FDA-cleared medical fingertip pulse oximeter available over the counter (OTC), direct to consumers without a prescription. Irvine, California-based Masimo powers its OTC pulse oximeter with […]
Wandercraft wins FDA clearance for exoskeleton for people with spinal cord injuries
Wandercraft announced today that it received FDA clearance for its Atalante X exoskeleton for individuals with spinal cord injuries (SCIs). The FDA granted clearance for people with SCIs at levels T5 to L5 to utilize the self-balancing robotic exoskeleton technology. The system enables those with limited mobility to stand up and walk again. Wandercraft says […]
FDA approves MRI labeling on Mainstay Medical’s ReActiv8 restorative neurostimulation system
Mainstay Medical this week announced it received FDA approval for MRI labeling on its ReActiv8 restorative neurostimulation system. The approval allows patients implanted with the 45 cm ReActiv8 leads to be eligible for full-body MRI scans. Patients will be able to undergo 1.5T full-body MRI scans. Specific scan conditions and safety information are provided in […]
FDA clears 5008X hemodialysis system from Fresenius Medical Care
Fresenius Medical Care announced today that it received FDA clearance for its 5008X hemodialysis system. The company said this marks a step toward bringing a new standard of care in dialysis therapy to the U.S. Bad Homburg, Germany-based Fresenius can now begin U.S.-based clinical evaluations and user studies ahead of a broad launch in 2025. […]
Philips wins FDA nod for latest IntelliVue patient monitor software including Sounds alarm package
Philips announced today that it received FDA 510(k) clearance for its latest IntelliVue patient monitor software. The latest IntelliVue technology includes several new solutions, including the Philips Sounds alarm package. This clearance means the alarm package now has availability in the U.S. and more than 200 countries worldwide. Philips worked with clinicians and sound experts […]
Philips has a serious BrightView recall due to potential falling component
Philips issued a recall notification deemed Class I — the most serious kind — for its BrightView SPECT imaging systems. In December 2023, Philips notified customers about a potential issue with BrightView systems (including BrightView, BrightView X and BrightView XCT). Under specific circumstances, the detector may move downward due to a potential component (lead screw) […]