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. […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
The UK wants to deliver medical supplies via drone
A new proposal from the U.K. Civil Aviation Authority (CAA) sets out a plan for medical supply delivery through drone operations. These proposals are part of the U.K. Future Flight Programme and seek to expand drone capabilities by permitting operations beyond remote pilots’ visual line of sight (BVLOS). The proposed measures involve drones operating at […]
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 […]
Jill Biden launches $100M initiative to transform women’s health research
Dr. Jill Biden and the White House this week announced that $100 million in federal funding will go toward research and development into women’s health. The First Lady said the funding is part of a White House Initiative on Women’s Health Research that the White House announced in November. The Federal Department of Health and […]
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 […]
Boston Scientific warns on fragment embolization in some PolarSheath devices
Boston Scientific has issued an urgent field safety notice for some of its PolarSheath steerable sheaths due to the risk of embolization. The company is removing specific batches of PolarSheath steerable sheaths due to a tooling error in manufacturing, which may have caused delimitation of the inner lumen of the sheath shaft in a subset […]
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 […]