The FDA issued a notice deeming a recall of Medtronic [WtwhTicker symbol="MDT"](NYSE: MDT)[/WtwhTicker] McGrath Mac video laryngoscopes Class I, the most serious kind. This recall involves removing certain devices from where they are used or sold as the device may cause serious injury or death if people continue using it. It also includes … [Read more...] about Medtronic recalls McGrath Mac laryngoscope due to potential for explosions
Endoscopes
Olympus’ Odin Medical wins FDA nod for first cloud-based AI endoscopy system for colonoscopy
Olympus announced today that its Odin Medical unit received FDA 510(k) clearance for its Caddie computer-aided detection (CADe) device. The cloud-based AI technology assists gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures. Olympus says its the first cloud-based AI technology for this purpose. It could … [Read more...] about Olympus’ Odin Medical wins FDA nod for first cloud-based AI endoscopy system for colonoscopy
Karl Storz, Fujifilm partner on next-gen endoscopy tech
Karl Storz U.S. and Fujifilm Healthcare Americas today announced a partnership to provide comprehensive solutions for endoscopists and surgeons. The companies plan to jointly market Fujifilm's flexible gastrointestinal (GI) endoscopes along with Karl Storz's OR integration solutions. Together, they aim to enhance the experience for surgical ORs, … [Read more...] about Karl Storz, Fujifilm partner on next-gen endoscopy tech
Pentax wins FDA nod for duodenoscope with new sterilization tech
Pentax Medical announced today that the FDA cleared its DEC duodenoscope compatibility with the Sterrad 100NX sterilizer. Advanced Sterilization Products (ASP) develops Sterrad as its flagship product. Together, the companies aim to address the ongoing challenges of duodenoscope reprocessing. They hope to reduce the risk of cross-contamination … [Read more...] about Pentax wins FDA nod for duodenoscope with new sterilization tech
Olympus launches duo of bronchoscopes for Evis X1 endoscopy system
Olympus today announced the launch of two bronchoscopes as part of its Evis X1 endoscopy system for diagnostic and therapeutic bronchoscopy. Tokyo-based Olympus — which has its Olympus Corporation of the Americas headquarters in Center Valley, Pennsylvania — designed the new scopes with high-definition imaging capabilities. They offer physicians … [Read more...] about Olympus launches duo of bronchoscopes for Evis X1 endoscopy system
Pentax Medical’s i20c video endoscopes wins CE mark
Pentax Medical this week announced it received CE mark approvals for new models of its i20c video endopscope series. The approval covers the Pentax Medical Video Colonoscope EC34-i20c, Pentax Medical Upper GI Scope EG27-i20c and the R/L Knob Adaptor OE-B17. Pentax Medical's i20c Video Endoscope Series, when used with the Inspira Video … [Read more...] about Pentax Medical’s i20c video endoscopes wins CE mark
FDA clears FujiFilm’s Scale Eye endoscopic imaging tech
FujiFilm today announced it received FDA 510(k) clearance for its Scale Eye endoscopic imaging technology. Scale Eye is part of the company's expanding Eluxeo endoscopic imaging system. It has a laser-equipped colonoscope and endoscopy support software that displays linear or circular vital measurements or scales on an endoscopy monitor. The … [Read more...] about FDA clears FujiFilm’s Scale Eye endoscopic imaging tech
Olympus bronchoscopes in Class I recall could lead to burns, fire
The FDA labeled a recall of Olympus bronchoscopes that could lead to burns or fire Class I, the most serious kind. Olympus reports 192 complaints related to the issue, including four injuries. The company has received no reports of death. This recall — a correction, not a product removal — applies to Olympus bronchofiberscopes and … [Read more...] about Olympus bronchoscopes in Class I recall could lead to burns, fire
Olympus has more warnings over bronchoscopes
Olympus has initiated a voluntary field corrective action following reports of endobronchial combustion incidents involving bronchoscopes. The field corrective action — announced Nov. 9 — is taking place after incidents occurred during medical procedures utilizing high-frequency therapy equipment in environments rich in oxygen, according to the … [Read more...] about Olympus has more warnings over bronchoscopes
Olympus launches Evis X1 endoscopy system
Olympus recently announced it launched the Evis X1 endoscopy system in the U.S. The Evis X1 received FDA clearance earlier this year with two compatible endoscopes, the GIF-1100 gastrointestinal videoscope and the CF-HQ1100DL/I colonovideoscope. It is indicated for use in the upper digestive tract and the lower digestive tract. Evis X1 has an … [Read more...] about Olympus launches Evis X1 endoscopy system
