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Endoscopes

Olympus launches single-use hemostasis clip

March 5, 2025 By Sean Whooley

Olympus Retentia HemoClip hemostasis clip (1)

Olympus announced that it launched a new hemostasis clip to meet the needs of gastrointestinal (GI) endoscopists. The company's Retentia HemoClip offers 360° rotation and an intuitive one-step deployment. This provides control over placement with three different sizes to accommodate a variety of closure applications. Retentia HemoClip … [Read more...] about Olympus launches single-use hemostasis clip

Filed Under: Applications, Business, Cardiology, Catheters, Endoscopes, Technologies & Devices Tagged With: olympus

Olympus has a serious endoscope guide sheath recall

February 28, 2025 By Sean Whooley

This images shows the Olympus logo.

The FDA today issued a notice warning of the removal of certain single-use guide sheath kits for endoscope instruments by Olympus. This recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type of recall, as it may cause serious injury or death. Olympus warned customers to not … [Read more...] about Olympus has a serious endoscope guide sheath recall

Filed Under: Catheters, Endoscopes, Regulatory, Technologies & Devices, Tubing Components Tagged With: olympus

Pentax wins FDA nod for new models of endoscopes

December 10, 2024 By Sean Whooley

Pentax Medical i20c video endoscope series (1)

Pentax Medical announced today that it earned FDA 510(k) clearance for new models of its i20c video endoscope series. The new models — the Video Colonoscope EC34-i20cL, Video Upper GI Scope EG27‑i20c and Right/Left Wheel Extender OE-B17 — work in combination with the Pentax Medical Inspira Video Processor EPK-i8020c. They support healthcare … [Read more...] about Pentax wins FDA nod for new models of endoscopes

Filed Under: 510(k), Endoscopes, Regulatory, Technologies & Devices Tagged With: pentax, Pentax Medical

Endostart wins CE mark to bring magnetic balloon tech to enteroscopy

October 11, 2024 By Sean Whooley

EndoStart Endorail

Endostart announced today that it received CE mark approval for the expanded use of its flagship Endorail product. Certaldo, Italy-based Endostart designed Endorail to provide efficiency and safety in endoscopic procedures. The technology utilizes a magnetic balloon system to enhance control of the endoscope in both the small and large bowel. It … [Read more...] about Endostart wins CE mark to bring magnetic balloon tech to enteroscopy

Filed Under: Balloons, Catheters, CE Mark, Endoscopes, Regulatory, Technologies & Devices Tagged With: Endostart

Medtronic recalls McGrath Mac laryngoscope due to potential for explosions

September 5, 2024 By Sean Whooley

FDA Medtronic McGrath Mac video laryngoscope recall

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

Filed Under: Endoscopes, Recalls, Regulatory, Technologies & Devices Tagged With: medtronic

Olympus’ Odin Medical wins FDA nod for first cloud-based AI endoscopy system for colonoscopy

September 5, 2024 By Sean Whooley

This images shows the Olympus logo.

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

Filed Under: 510(k), Endoscopes, Regulatory, Technologies & Devices Tagged With: fda, Odin Vision, olympus

Karl Storz, Fujifilm partner on next-gen endoscopy tech

August 26, 2024 By Sean Whooley

Karl Storz Fujifilm endoscopy partnership

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

Filed Under: Endoscopes, Technologies & Devices Tagged With: fujifilm, Karl Storz

Pentax wins FDA nod for duodenoscope with new sterilization tech

August 5, 2024 By Sean Whooley

Hoya subsidiary Pentax Medical

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

Filed Under: 510(k), Business, Endoscopes, Partnerships, Regulatory, Technologies & Devices Tagged With: Advanced Sterilization Products, pentax, Pentax Medical

Olympus launches duo of bronchoscopes for Evis X1 endoscopy system

May 13, 2024 By Sean Whooley

Olympus Evis X 1 bronchoscopes

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

Filed Under: Endoscopes, Technologies & Devices Tagged With: olympus

Pentax Medical’s i20c video endoscopes wins CE mark

February 28, 2024 By Danielle Kirsh

Hoya subsidiary Pentax Medical

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

Filed Under: Endoscopes Tagged With: Pentax Medical

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