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
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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
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
Olympus acquires GI stent maker Taewoong Medical for $370M
Olympus announced that it agreed to acquire Korea-based Taewoong Medical, a maker of medical devices, including stents, for $370 million. Taewoong Medical manufactures devices including gastrointestinal (GI) metallic stents. Olympus intends to use the acquisition to strengthen its GI endotherapy portfolio capabilities. Get the full story at our … [Read more...] about Olympus acquires GI stent maker Taewoong Medical for $370M
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
The top 10 catheter innovations of 2021
Last year was a big year for catheter innovation as medtech companies large and small received regulatory approvals for devices ranging from TAVR to single-use endoscopes. Catheter innovations weren't limited to just adults; Catheter-deployed devices for premature babies and toddlers were also approved and released. And catheter-based devices … [Read more...] about The top 10 catheter innovations of 2021
Olympus acquires Israel-based Medi-Tate
Olympus (TYO:7733) announced that it finalized the acquisition of benign prostatic hyperplasia (BPH) treatment developer Medi-Tate. The Japanese conglomerate did not disclose the financial terms of the acquisition, which was finalized after the company exercised a call option in February, according to a news release. Get the full story at our … [Read more...] about Olympus acquires Israel-based Medi-Tate
FDA clears Olympus airway mobilescopes
Olympus (TYO:7733) today said it received FDA clearance for its line of airway mobilescopes. The mobilescopes enable physicians to perform a broad range of upper and lower airway management procedures. "We are proud to present to the market the only flexible mobilescope models with a video camera on the tip," Lynn Ray, VP and GM of global … [Read more...] about FDA clears Olympus airway mobilescopes
Olympus launches five single-use bronchoscopes
Olympus today said it has launched its product line of five H-SteriScope single-use bronchoscopes. The single-use endoscopes are for diagnostic and therapeutic procedures. They resulted from a collaboration between Olympus subsidiary Veran Medical Technologies and Hunan Vathin Medical Instrument. "We are very excited to launch our first line … [Read more...] about Olympus launches five single-use bronchoscopes
