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 […]
Software / IT
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 […]
Tandem Diabetes Care taps miniaturization and automation for its latest systems
Tandem Diabetes Care (Nasdaq:TNDM) EVP and Chief Strategy Officer Elizabeth Gasser didn’t exactly plan for the whirlwind past year or so. In the space of about two months, Tandem announced continuous glucose monitor (CGM) integration with the latest-generation technology from Dexcom and Abbott, launched its Tandem Source diabetes management platform and began the rollout of […]
GE HealthCare unveils AI-enabled urology software
GE HealthCare announced today that it launched its Prostate Volume Assist (PVA) urology-based AI software feature. The company designed the software feature to support clinicians in prostate imaging, biopsies and guiding treatment. It assists urologists by improving workflows and quickly capturing prostate volume. The added functionality with PVA helps determine calculations and measurements of the […]
SyntheticMR wins FDA clearance for 3D brain scanner
SyntheticMR announced today that its next-generation 3D imaging solution with isotropic resolution received FDA 510(k) clearance. Linköping, Sweden-based SyntheticMR said in a news release that the regulatory nod “marks a significant advancement in quantitative MRI technology.” The company says its SyMRI 3D offering provides “unprecedented resolution and accuracy in brain imaging.” Approval marks the second […]
Butterfly Network wins CE mark for IQ+ handheld ultrasound tech, hopes for next-gen nod this year
Butterfly Network (NYSE:BFLY) announced today that it garnered CE mark approval for its Butterfly iQ+ ultrasound system. The company obtained European Union Medical Device Regulation (EU MDR) certification for the iQ+ system. It initially received CE mark in 2021, but had to fall in line with updated, more stringent regulations in Europe. According to a […]
Fujifilm wins FDA nod for AI-powered endoscopy tech that could rival Medtronic’s GI Genius
Fujifilm announced today that the FDA granted 510(k) clearance for its CAD Eye AI-powered detection system for endoscopic imaging. CAD Eye enables the real-time detection of colonic mucosal lesions like polyps and adenomas during colonoscopy procedures. It supports endoscopists in detecting and removing pre-cancerous lesions, regardless of size, shape and color. The system enters a […]
Medtronic is raising the bar on outcomes with MiniMed 780G automated insulin delivery system
Not long ago, automated insulin delivery technology from Medtronic ranked third in the market in terms of patient satisfaction. That’s according to the Diabetes Patient Voice survey (DQ&A) — a third-party survey that evaluates U.S. diabetes patient satisfaction on a quarterly basis. However, things are now looking up for the world’s largest medtech company in […]
After Intuitive, Shockwave and Avail, Daniel Hawkins is now CEO at AI-powered MRI software startup Vista.ai
Avail Medsystems founder and former CEO Daniel Hawkins has a new job as president and CEO of MRI software startup Vista.ai. Palo Alto, California-based Vista.ai (founded and incorporated as HeartVista) makes AI-guided software for automating magnetic resonance imaging (MRI) exams. “Vista is the only MRI-related AI company that is not doing just post-processing — Vista […]
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 […]