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
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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
5 innovations to make duodenoscopes more single-use — and save lives
Duodenoscopes are important medical devices that are used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, the devices have had serious problems in the past. Luckily, several medical device companies have stepped in to solve the problems. (Here are five of the innovations.) Duodenoscopes are flexible, lighted … [Read more...] about 5 innovations to make duodenoscopes more single-use — and save lives
Olympus debuts hybrid tubing and procedure kits
Olympus (TYO:7733) this week said it launched its procedure kits and hybrid tubing. The company launched the procedure kits in partnership with Ruhof Corporation to grow its end-therapy portfolio. The kits are designed to aid in the setup and execution of application endoscopy procedures to improve procedural efficiency and post-procedure … [Read more...] about Olympus debuts hybrid tubing and procedure kits
Olympus launches esophagus through-the-scope stent
Olympus today announced it commercially launched its Hanarostent esophagus TTS self-expanding metal stents. The through-the-scope esophageal stent helps with luminal patency in a variety of clinical applications. It is designed for use in the palliative treatment of esophageal stricture or trachea-esophageal fistula caused by malignant … [Read more...] about Olympus launches esophagus through-the-scope stent
