Varian announced today that it received FDA 510(k) clearance for its TrueBeam and Edge radiotherapy systems with HyperSight imaging. The Siemens Healthineers company designed HyperSight to empower clinicians to accurately tailor treatments to individual patients. This helps improve patient outcomes, thanks to new capabilities and workflows across the company’s linear accelerators. HyperSight allows clinicians to […]
Food & Drug Administration (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 […]
FDA clears sacroiliac joint fusion device from Nevro
Nevro (NYSE:NVRO) announced today that the FDA cleared its sacroiliac (SI) joint fusion device without the need to include an accompanying screw. Redwood City, California-based Nevro plans to market this device as Nevro1, without the need for the NevroFix screw. The system aims to immediately transfix the SI joint, allowing the opportunity for long-term fusion. […]
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 […]
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 […]
FDA clears ROSA Shoulder robotic surgery system from Zimmer Biomet
Zimmer Biomet announced today that it received FDA 510(k) clearance for its ROSA Shoulder robotic-assisted surgery system. The company says this marks the clearance of the world’s first robotic surgery system for shoulder replacement. It’s also the fourth application for the ROSA (Robotic Surgical Assistant) portfolio, which includes the ROSA Knee and ROSA Hip. Zimmer […]
Sira Medical wins FDA nod for augmented reality surgical planning tech
Sira Medical announced today that it received FDA 510(k) clearance for its augmented reality (AR) preoperative surgical planning application. The San Francisco-based company’s application offers clinicians with advanced imaging to assist in making key patient management decisions. According to a news release, Sira Medical wants to address a lack of clarity caused by hidden anatomy […]
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 […]
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 […]