Epitel announced today that it received FDA 510(k) clearance for two new patient-focused brain health offerings. The FDA cleared the Remi remote EEG monitoring system for ambulatory use and the Remi Vigilenz AI for event detection. Remi for ambulatory use allows for EEG recording in outpatient and home environments for an extended duration. Vigilenz AI […]
Machine Learning (ML)
Medtronic unveils new AI for laparoscopic, robotic surgery tech
Medtronic today announced new AI capabilities to go with the launch of its Touch Surgery Live Stream digital offering. The medtech giant’s 14 new AI algorithms enhance its digital capabilities within post-operative analysis. Medtronic said they provide AI surgical insights across laparoscopic and robotic-assisted surgery. Along with the algorithms, Medtronic launched its Touch Surgery Live […]
Biotronik unveils new AI-powered insertable cardiac monitor
Biotronik announced that it received CE mark approval and completed the first European implant of its latest insertable cardiac monitor (ICM). The BioMonitor IV features AI capabilities for false positive reduction. The AI cuts false positives for AFib, bradycardia, tachycardia and pause. According to Biotronik, its SmartECG reduces 86% of false detections across all major […]
RefleXion inks AI partnership for cancer treatment planning
RefleXion Medical announced today that it signed a licensing agreement with Limbus AI to incorporate software into radiation treatment planning. The agreement enables the integration of the Limbus Contour automated contour software into the RefleXion X1 system. X1 uses biology-guided radiotherapy (BgRT) technology. It enables a PET radiotracer to create a unified motion management solution […]
FDA clears sleep monitoring software from Beacon Biosignals
Beacon Biosignals announced that it received FDA 510(k) clearance for its SleepStageML machine-learning software for sleep monitoring. SleepStageML automatically stages sleep from electroencephalogram (EEG) signals of clinical polysomnography (PSG) recordings. It aids in the diagnosis and evaluation of sleep and sleep-related disorders. Boston-based Beacon Biosignals said in a news release that the software could enable […]
How Solventum plans to create value after spinning out of 3M
Bryan Hanson, soon-to-be CEO of 3M’s Solventum healthcare spinoff, is no stranger to major changes in medtech. He had direct involvement in medtech’s largest spinoff, when Covidien separated from Tyco. Hanson then led the integration of Covidien into Medtronic in medtech’s largest-ever acquisition. While at Medtronic, he also led the divestiture of its Patient Recovery […]
GE HealthCare, Nvidia team up to bring AI to ultrasound
GE HealthCare announced that it utilized Nvidia technology to develop an AI-powered research model called SonoSAMTrack. SonoSAMTrack combines a promptable foundation model for segmenting objects on ultrasound images called SonoSAM. It segments anatomies, lesions and other essential areas in ultrasound images. GE HealthCare also offers a streamlined version called SonoSAMLite. The latest development builds on […]
GE HealthCare, Mass General bring AI to imaging
GE HealthCare announced today that it plans to expand its AI partnership with Mass General Brigham. The two began work on AI solutions after announcing a 10-year commitment in 2017. They set out to explore AI across a broad range of diagnostic and treatment paradigms through sustainable AI development. In September, they announced an effort […]
Philips, AWS expand partnership on digital pathology in the cloud
Philips today announced an expanded partnership with Amazon Web Services (AWS) based around digital pathology in the cloud. The two initially linked up about a year ago, inking a deal to develop generative AI applications. This partnership centered around Philips’ imaging archiving and communications system. It wasn’t the first time a medtech giant linked up […]
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 […]