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 […]
Insulet picks new CFO following McMillan’s move to 3M spinoff
Insulet announced today that it appointed Ana Maria Chadwick as its new EVP, CFO and treasurer. Chadwick’s appointment — which goes into effect on April 22, 2024 — follows an extensive search process conducted by Insulet. That search spanned nearly six months after former CFO Wayde McMillan left for 3M’s Solventum healthcare spinoff in October. […]
FDA issues warning letter to Medline over plastic syringes from China
The FDA followed up on a 2023 warning letter over unauthorized plastic syringes by issuing a warning letter to Medline. In November, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated […]
Health Canada licenses Medtronic Symplicity Spyral renal denervation system
Medtronic announced today that it received a license from Health Canada for its Symplicity Spyral renal denervation (RDN) system. The licensing covers the management of essential hypertension in patients for whomblood pressure remains uncontrolled despite lifestyle modifications and guideline-driven medical therapy with antihypertensive medications, or when guideline-driven therapy is poorly tolerated. Approval in Canada comes […]
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 […]
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, […]
Siemens Healthineers to close Fast Track Diagnostics unit
Siemens Healthineers announced today that it intends to close its Fast Track Diagnostics Unit in a move that affects just shy of 100 workers. The business closure affects about 90 employees, mostly based in Luxembourg. The company has conversations underway with local employee representatives and plans to follow local labor regulations and guidelines in accordance […]
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 […]