Olympus (TYO:7733) announced that it has received FDA 510(k) clearance for its PCF-H190T and PCF-HQ190 colonoscopes. Center Valley, Pa.-based Olympus’ two newly cleared colonoscopes provide an extension to the existing capabilities of physicians to diagnose and treat disorders of the gastrointestinal tract, according to a news release. PCF-H190TL/I is a slim, short-bending scope designed for tighter […]
Olympus
Olympus announces new endoscope reprocessing technology
Olympus (TYO:7733) announced today that it launched its OER-Elite next-generation automated endoscope reprocessor (AER) on the market. Center Valley, Pa.-based Olympus’ OER-Elite is designed to simultaneously clean and disinfect up to two endoscopes in 28 minutes with Acecide-C, a peracetic, acid-based disinfectant. It also includes a cleaning cycle with a combination of EndoQuick alkaline detergent and […]
Olympus to acquire Arc Medical Design
Olympus (TYO:7733) recently announced that it has signed a definitive agreement to acquire Arc Medical Design for an undisclosed amount. Through the agreement, Olympus will acquire the company and obtain full rights to its suite of innovative medical products. It will convert its exclusive distribution rights of Endocuff Vision to a full acquisition of the product […]
Olympus launches Evis X1 endoscopy system
Olympus today said it launched its Evis X1 endoscopy system. Evis X1 is designed to improve outcomes from disorders of the stomach, colon and esophagus as well as various bronchial diseases. It features easy-to-use technologies to support how gastrointestinal disorders like colorectal cancer (CRC) are detected, characterized and treated. The system features extended depth of […]
Olympus lands FDA de Novo approval for benign hyperplasia device
Olympus (TYO:7733) announced today that it received FDA de Novo classification for its iTind non-surgical device for treating benign prostatic hyperplasia (BPH). Israel-based medical device manufacturer Medi-Tate originally designed the iTind device. Olympus holds the exclusive right to distribute Medi-Tate products in the U.S. through a strategic investment. The iTind is designed as a flexible, three-strut […]
FDA recommends limiting use of power morcellators
The FDA today recommended that laparoscopic power morcellators, which have been implicated in the spread of cancer, be limited to use with certain tissue containment systems and only in premenopausal women under 50 years of age. Power morcellators were used for 20 years to laparoscopically remove benign tumors of the uterus, known as fibroids, by mincing them. […]
FDA clears Olympus duodenoscope with disposable endcap
Olympus (TYO:7733) announced that it won FDA clearance for its TJF-Q190V duodenoscope with a sterile, disposable distal endcap. The new duodenoscopes are designed to improve the cleaning and reprocessing of the device to reduce contamination. The device is a result of the FDA’s call for more duodenoscopes that are disposable. FDA in August 2019 recommended that […]
Sony to deal $760m stake back to Olympus
Sony (TYO:6758) will reportedly sell its 5% stake in Olympus (TYO:7733) back to the company for nearly $760 million. The deal for Sony’s 68.9-million-share stake is worth ¥80.4 billion, or about $756.7 million, Reuters reported. Hedge fund Third Point, run by activist investor Daniel Loeb, had called for Sony to divest its Olympus shares, although a Sony […]
FDA pushes duodenscope makers, users away from reprocessed devices
The FDA yesterday recommended that healthcare providers move away from a type of infection-prone duodenoscope in favor of devices that can better be sterilized, after post-market surveillance again found higher-than-expected contamination rates of “high-concern organisms.” In April the FDA revealed new data showing that rates of so-called “superbug” infections were nearly twice as high as […]
Former Olympus exec gets probation for allowing faulty device sales
Olympus’ former top regulatory official has dodged a prison term for failing to file adverse event reports with the FDA regarding infections connected to contaminated duodenoscopes, according to published reports. Hisao Yabe, 64, and Tokyo-based Olympus (TYO:7733) both entered guilty pleas in December in U.S. District Court in Newark, N.J. for failing to file the […]
Olympus inks deal to distro Meditech Endoscopy’s Scope Pro-tech tip protector
Olympus (TYO:7733) said today that it inked a deal with Meditech Endoscopy to act as the exclusive distributor of its Scope Pro-tech endoscopic tip protector device, which won FDA clearance this month. The Scope Pro-tech tip protector is a sterile, cage-like cover designed to protect the distal tip and bending rubber section of endoscopes from impact […]
