Olympus is warning health providers about incompatible laser use with bronchoscopes after receiving reports of endobronchial combustion, serious patient injury, and one death. The Japanese medtech giant said on July 3 that its voluntary field corrective action involves 32 BF series endoscope models, 19 of which it distributes in the U.S. The … [Read more...] about Olympus corrective action covers laser-compatible bronchoscopes
Endoscopes
Olympus to establish series of digital centers based on Odin Vision’s cloud-AI tech
Olympus announced that it plans to establish a series of digital excellence centers (DECs) following its acquisition of Odin Vision. London-based Odin Vision develops a portfolio of commercially available computer-aided detection/diagnostic (CAD) solutions. It also holds an innovation pipeline of cloud-enabled applications. Olympus agreed to … [Read more...] about Olympus to establish series of digital centers based on Odin Vision’s cloud-AI tech
FDA clears Olympus endoscopy systems and endoscopes
Olympus today announced it received FDA clearance for its new Evis X1 endoscopy system and two compatible gastrointestinal endoscopes. The FDA clearance covers Olympus’ GIF-1100 gastrointestinal videoscope indicated for use in the upper digestive tract, and the CF-HQ1100DL/I colonovideoscope indicated for use in the lower digestive … [Read more...] about FDA clears Olympus endoscopy systems and endoscopes
EvoEndo CEO to leave, replacement named
EvoEndo announced today announced a new CEO and COO along with the departure of previous CEO Heather Underwood. Denver-based EvoEndo, which develops transnasal endoscopy technology, named Jonathan Hartmann as president and CEO. It appointed Ryan Hartman to the COO position. Underwood intends to remain with the company through April to support … [Read more...] about EvoEndo CEO to leave, replacement named
Cook Medical, Vizient ink contract for endoscopy devices
Cook Medical announced today that it received a contract with Vizient covering the company's endoscopy devices. The contract enables Cook to continue offering its endoscopy devices at negotiated pricing terms to Vizient members. “We are honored to have been chosen as an Endoscopy contracted supplier with Vizient," said Rick Simms, Cook … [Read more...] about Cook Medical, Vizient ink contract for endoscopy devices
FDA sends warning letter to Olympus over endoscope manufacturing
The FDA issued Olympus a warning letter regarding adultered devices following an inspection of the company’s Tokyo facility. This marks the latest warning letter sent by the FDA to Olympus. The company received two separate letters at the end of last year. According to the letter, the agency conducted an inspection of the Tokyo facility … [Read more...] about FDA sends warning letter to Olympus over endoscope manufacturing
This surgical robotic arm could 3D bioprint inside the human body
Engineers in Australia say they have developed a miniature robotic arm for 3D printing biomaterial directly on human organs. UNSW Sydney researchers developed the device as a flexible, soft robotic arm for 3D bioprinting. This process fabricates biomedical parts from “bioink” to construct natural, tissue-like structures. Predominantly used for … [Read more...] about This surgical robotic arm could 3D bioprint inside the human body
FDA clears single-use endotherapy device from Lumendi
Lumendi today announced it received FDA 510(k) clearance for two of its single-use, disposable endotherapy devices. The Westport, Connecticut-based company received FDA clearance for its DiLumen EZ¹ single-use, disposable end-therapy device for endoscopic mucosal resections and difficult colonoscopies. Its DiLumen C¹ was also cleared for use in … [Read more...] about FDA clears single-use endotherapy device from Lumendi
FDA hits Olympus with warning letters after factory inspections
The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities. The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations. “Olympus’ highest … [Read more...] about FDA hits Olympus with warning letters after factory inspections
FDA clears Pristine Surgical single-use arthroscope
Pristine Surgical announced today that FDA has cleared its Summit 4K single-use surgical arthroscope Manchester, New Hampshire–based Pristine describes the arthroscope as a first of its kind. It plans to launch Summit during the first quarter of this year. Summit combines a 4K single-use surgical arthroscope with the company's cloud-based … [Read more...] about FDA clears Pristine Surgical single-use arthroscope
