Apple today unveiled new sleep and hearing health features for its Apple Watch and AirPods Pro 2, expanding its health metrics offerings. The Apple Watch now offers sleep apnea notifications, utilizing the tech giant’s new breathing disturbances metric. Apple says it expects FDA authorization soon, along with approval in other geographies. The company plans to […]
Machine Learning (ML)
Exactech unveils new AI research for ortho applications
Exactech today shared new research demonstrating the potential of AI and radiomic analyses in shoulder arthroplasty. The Gainesville, Florida–based company also shared new advances in its Active Intelligence ecosystem of smart technologies. It presented its findings at the Congress of International Society for Technology in Arthroplasty (ISTA) in Nashville, Tennessee. Exactech’s research demonstrated how machine […]
FundamentalVR unveils new version of Apple Vision Pro app for medical training
FundamentalVR announced that it released the second version of its surgical training application for the Apple Vision Pro system. Boston-based FundamentalVR made the update available on the visionOS App Store. It offers a refined immersive environment specifically designed to support hands-on medical training. That includes replicating a real-world cath lab. The second version of the […]
Olympus’ Odin Medical wins FDA nod for first cloud-based AI endoscopy system for colonoscopy
Olympus announced today that its Odin Medical unit received FDA 510(k) clearance for its Caddie computer-aided detection (CADe) device. The cloud-based AI technology assists gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures. Olympus says its the first cloud-based AI technology for this purpose. It could potentially go up against the Medtronic AI-enabled GI Genius […]
Butterfly Network adds former Caption Health CEO as chief business officer
Butterfly Network announced today that it appointed Steve Cashman as its new chief business officer (CBO). Cashman joins the Burlington, Massachusetts-based company following this year’s rollout of the company’s next-generation handheld ultrasound. His arrival comes on the heels of record-setting revenues at the company as well, according to a news release. Cashman joins the company’s […]
FDA clears next-gen surgical robot from Procept Biorobotics
Procept BioRobotics (Nasdaq:PRCT) announced today that it received FDA 510(k) clearance for its next-generation Hydros robotic surgery system. Hydros delivers the San Jose, California-based company’s Aquablation therapy. The company received FDA investigational device exemption (IDE) for its Aquablation procedure in September 2023. Aquablation uses waterjet resection to precisely eradicate prostate tissue. It provides the potential […]
Allurion could face NYSE delisting
Allurion Technologies (NYSE:ALUR) announced that it received notice from the New York Stock Exchange that it fell out of compliance with listing standards. The NYSE notified Allurion that its stock’s average closing price fell below $1 per share over 30 consecutive trading days ending Aug. 8. This notice does not result in the immediate delisting […]
Caresyntax raises $180M to support AI-enabled surgical software
Caresyntax announced today that it raised $180 million through a Series C financing extension and growth debt expansion round. Symbiotic Capital, MTIP AG, BIONIQ Capital, PFM Health Sciences, Pictet Alternative Advisors, surgical.ai, BlackRock Innovation Capital, Aescuvest, Optum Ventures, Cure Capital, Relyens Group, Vesalius Biocapital, Lauxera Capital, Plug & Play Growth Fund and ProAssurance Corp. all […]
FDA clears Siemens Healthineers’ AI-powered cardiovascular ultrasound and catheter
Siemens Healthineers announced today that it received FDA clearance for its Acuson Origin ultrasound system and AcuNav Lumos 4D ICE catheter. Acuson Origin, a new, dedicated cardiovascular ultrasound includes AI-powered features. It can help physicians perform cardiac procedures more efficiently in the areas of diagnostics, structural heart disease and electrophysiology. The AcuNav Lumos 4D ICE […]
Surgical Planning Associates wins FDA nod for mixed-reality hip arthroplasty system
Surgical Planning Associates announced today that it received FDA 510(k) clearance for its HipInsight 2.0 mixed-reality guidance system. Boston-based Surgical Planning Associates developed the system for hip arthroplasty in collaboration with orthopedic giant Zimmer Biomet. It provides support for the essential steps of both primary and complex revision arthroplasty. HipInsight effectively gives surgeons “X-ray vision” […]
FDA clears Masimo W1 medical watch for telemonitoring connectivity
Masimo announced today that the FDA granted 510(k) clearance for its W1 medical watch for connectivity purposes. Clearance allows for the watch to integrate with the Masimo SafetyNet comprehensive telemonitoring system. Last fall, the FDA cleared the W1 watch, which provides continuous oxygen saturation (SpO2) and pulse rate (PR) for over-the-counter and prescription use at […]
