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 […]
510(k)
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. […]
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 […]
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 […]
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 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. […]