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 […]
Software / IT
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 […]
Johnson & Johnson MedTech partners with Nvidia on AI in surgery
Johnson & Johnson MedTech announced today that it plans to accelerate and scale AI for surgery in partnership with Nvidia. The two companies paired up to support increased access to real-time analysis and global AI algorithm availability. They hope to affect surgical decision-making, education and collaboration across the connected operating room (OR). This marks the […]
Carlsmed raises $52.5M Series C for spine surgery platform
Carlsmed announced today that it raised $52.5 million in a Series C funding round co-led by B Capital and U.S. Venture Partners. The Carlsbad, California-based AI-enabled personalized surgery company plans to use the funds to accelerate commercialization efforts. It wants to boost the commercialization of its aprevo personalized spine surgery platform for lumbar fusion procedures, […]
Surgeons perform first total knee arthroplasty with Polaris mixed-reality surgical guidance tech
Polaris announced today that surgeons performed the first total knee arthroplasty (TKA) during its Stellar Knee mixed-reality system. Stellar Knee uses mixed reality for surgical navigation and guidance. It guides TKA procedures by displaying measured and computed data overlaid directly in a 3D environment. The system acts as a spatial computer, creating continuous data exchange […]
FDA clears automated insulin delivery system from Sequel Med Tech
Sequel Med Tech announced today that its partner, DEKA R&D, won FDA 510(k) clearance for its automated insulin delivery (AID) system. The twist system, powered by Tidepool, directly measures the volume and flow of insulin delivered with every microdose. It offers the capability and flexibility to address each patient’s individual dosing needs. Sequel will market […]