Boston Scientific announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Marlborough, Massachusetts–based Boston Scientific plans a U.S. launch for Agent in […]
FDA
Onward wins FDA breakthrough nod for use of neurostim with brain-computer interface
Onward Medical announced today that the FDA granted breakthrough device designation for its ARC-BCI system that uses brain-computer interface (BCI) technology. ARC-BCI uses BCI technology in conjunction with ARC-IM neurostimulation. It aims to restore thought-driven lower limb mobility after spinal cord injury (SCI). The BCI system uses AI to decode brain signals and translate them […]
How medtech could be affected by a U.S. government shutdown
Editor’s note: This article originally ran on September 29, 2023. It was updated on February 27, 2024 to reflect new staffing contingency plans and which departments will be affected by the March 1 shutdown. Congressional leaders over the weekend did not come to an agreement on legislation to fund several government agencies, including the FDA. […]
Virtual Incision wins FDA nod for miniature MIRA surgical robot for use in colectomies
Virtual Incision announced that the FDA granted marketing authorization to its MIRA miniaturized surgical robotic system. The FDA gave the nod for the use of the miniRAS (robotic-assisted surgery) system in adults undergoing colectomy procedures. MIRA went through the FDA’s de novo classification process, with findings based on an investigational device exemption (IDE) study. Virtual […]
New ClearPoint Neuro software wins FDA clearance, used in first cases
ClearPoint Neuro (Nasdaq:CLPT) announced that the FDA cleared its ClearPoint 2.2 software with integrated Maestro Brain Modeling. The Solana Beach, California-based company also reported the first-in-human cases following the FDA clearance. ClearPoint Neuro President and CEO Joe Burnett said the system now offers fast, peri-procedural segmentation of the cortical structures of the brain. This helps […]
FDA: Don’t use smartwatches, smart rings to measure blood glucose
The FDA issued a warning to consumers, patients, caregivers and providers around using certain technology to measure blood glucose. In the warning, the agency outlined the risks related to using smartwatches or smart rings for this purpose. Such devices may claim to measure blood glucose levels without piercing the skin. These devices are different from […]
Better Therapeutics wins FDA breakthrough nod for liver disease-treating digital therapeutic
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 […]
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 […]
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 […]
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) […]