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
Endoscopes
Dornier MedTech launches new ureteral access sheath and ureteroscope in U.S.
Dornier MedTech America announced the full U.S. commercial launch of two single-use devices, the Dornier Hoover Flexible and Navigable Suction Ureteral Access Sheath and the Dornier Axis II Slim ureteroscope. Both devices had already received FDA clearance and were in limited release before the full U.S. launch. The Hoover sheath provides … [Read more...] about Dornier MedTech launches new ureteral access sheath and ureteroscope in U.S.
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
Pavmed licenses endoscopic esophageal imaging tech out of Duke
Pavmed announced today that it executed a non-binding letter of intent to license endoscopic esophageal imaging technology from Duke University. Through a newly formed subsidiary, Pavmed licensed the technology designed to identify and facilitate treatment of advanced esophageal precancer (dysplasia) during upper endoscopy. It features a … [Read more...] about Pavmed licenses endoscopic esophageal imaging tech out of Duke
EvoEndo earns expanded FDA clearance for gastroscope
EvoEndo announced today that it received expanded FDA clearance for its Model LE gastroscope, covering patients of all ages. Denver-based EvoEndo's offering now covers neonates to adults, expanding the previous indication for patients aged five and older. The company says its system has been the only option available for sedation-free transnasal … [Read more...] about EvoEndo earns expanded FDA clearance for gastroscope
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
Pentax wins FDA nod for new models of endoscopes
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
Endostart wins CE mark to bring magnetic balloon tech to enteroscopy
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
