The US Food and Drug Administration has given de novo authorization to Medtronic plc and Cosmo Pharmaceuticals N.V.’s GI Genius endoscopy module. The device is the first of its kind to use artificial intelligence to help detect lesions during a colonoscopy, which could have major implications for fighting colon cancer.
FDA Authorizes GI Genius As A Smarter AI-Based Colonoscopy Tool
According to a large clinical study, the first such device with AI-enabled software is better at detecting potential lesions than traditional colonoscopies and could allow detection of colon cancer sooner.
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At AAOS, orthopedics players showcased their latest robotic-assisted platforms, power tools, 3D printed technologies and software offerings. This article brings you highlights from interviews Medtech Insight conducted on site with representatives from J&J, Stryker, Materialise and Canary Medical.
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Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.
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HistoSonics, which developed a noninvasive technology to destroy tumor cells, reports 90% local tumor control at 12-month follow-up in the #HOPE4Liver Trial. The Edison System, cleared by the US FDA in late 2023, is also being evaluated for kidney and pancreatic tumors. CEO Mike Blue said the medtech is financially secure but watching public markets as it considers an IPO.
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Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.
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While Roche continues to view China as a strategic growth market, a sharp 23% decline in Chinese diagnostics sales offset gains in other regions and segments. Despite near-term headwinds, Roche is betting on strong instrument placement growth across its Core Lab, Molecular, and Near Patient Care segments to fuel future demand for consumables and services–key components of its long-term medtech strategy.
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New continuous glucose monitoring manufacturing site in Indiana is part of Roche’s plan to boost its US presence. Roche’s launch of Accu-Chek SmartGuide system last year with AI-powered prediction capabilities puts it as a key differentiator from competitors such as Abbott and Dexcom.