Conmed announced that it plans to exit its gastroenterology product lines as part of a broader portfolio optimization strategy. Part of the exit includes the end of the company's distribution agreement with W.L. Gore & Associates related to the Gore Viabil biliary endoprosthesis. That deal dates back to 2006. Olympus and Gore announced in … [Read more...] about Conmed to exit gastroenterology product lines, transfer Gore Viabil rights to Olympus
olympus
Olympus issues label update for certain bronchoscopes related to endobronchial combustion
Olympus announced today that it made a voluntary corrective action to provide further clarification on the use of certain bronchoscopes. The company's global action aims to outline the safe and effective use of its bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment during therapeutic procedures … [Read more...] about Olympus issues label update for certain bronchoscopes related to endobronchial combustion
Gore, Olympus ink distro deal for Viabil endoprosthesis
Olympus announced today that it entered into a distribution agreement with W.L. Gore & Associates for the Gore Viabil biliary endoprosthesis. The international agreement makes Olympus the exclusive distributor for the Viabil endoprosthesis for endoscopic placement. Olympus plans to begin commercialization over the coming months, beginning in … [Read more...] about Gore, Olympus ink distro deal for Viabil endoprosthesis
Olympus issues voluntary recall for certain endoscope needles
Olympus announced a voluntary, global medical device removal of certain ViziShot 2 FLEX (19G) EBUS -TBNA (ViziShot 2 FLEX) needles. The company manufactured affected needles prior to May 12, 2025. It initiated the recall after receiving reports of device components detaching during procedures. Olympus said that it assessed the issue after … [Read more...] about Olympus issues voluntary recall for certain endoscope needles
Olympus enters distro deal with MacroLux for single-use urology products
Olympus announced an exclusive global distribution deal with MacroLux Medical Technology to distribute single-use urology products. The agreement includes multiple single-use cytoscopes, ureteroscopes and suction access sheaths. These devices offer access and visualization in the bladder and urinary tract. They enable the diagnosis and treatment … [Read more...] about Olympus enters distro deal with MacroLux for single-use urology products
FDA wants to prevent import of certain Olympus scopes manufactured in Japan
The FDA is notifying healthcare providers about import alerts for certain medical devices manufactured in Japan by Olympus and its subsidiaries. According to a notice, the FDA has "concerns related to outstanding quality system regulation violations by Olympus." The agency cites "extensive and ongoing efforts to address compliance issues" with the … [Read more...] about FDA wants to prevent import of certain Olympus scopes manufactured in Japan
Olympus launches single-use hemostasis clip
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
Olympus has a serious endoscope guide sheath recall
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
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
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
