ClearMind Biomedical announced today that it received FDA clearance for its Axonpen novel neuroendoscope system. Los Angeles-based ClearMind Biomedical’s Axonpen system is designed for the illumination and visualization of intracranial tissue and fluids, as well as the controlled aspiration of tissue and/or fluid during surgery, according to a news release. The system requires a 6.5 […]
Endoscopic
FDA authorizes marketing of new device designed to remove dead pancreatic tissue
The FDA announced that it authorized the marketing of Interscope’s EndoRotor system for resecting and removing necrotic tissue. Interscope’s EndoRotor system resects (cuts out) and removes necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), which can occur several weeks after an episode of severe acute pancreatitis and often requires tissue removal, according to […]
Olympus warns on endoscope infection risk
Olympus (TYO:7733) is advising healthcare providers to inspect certain ultrasound endoscopes before using them due to the potential for patient infection. The global recall covers 8,522 devices distributed in the U.S., according to FDA records. In an urgent field safety notice, the company listed 23 models of endoscopes that might contain residual blood and foreign matter […]
BREAKING: Johnson & Johnson finally unveils its new robot-assisted surgery system
Johnson & Johnson (NYSE:JNJ) today shared details on its surgical robotic platform that it says offers unrivaled flexibility and control compared to the rest of the market. The new system is designed with six arms to provide more control and flexibility in surgery, while its arms will be integrated into the operating table. Additionally, the platform […]
Olympus gains 510(k) clearance for colonoscopes
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 […]
Ambu, Xenecor ink purchasing deals for for single-use scopes
Ambu and Xenocor over the past week each announced agreements with U.S. healthcare purchasing groups involving single-use scopes. Ambu said on October 7 that it won a national single-use endoscopy contract in the single-use endoscope category of a “major U.S. group-purchasing organization.” The deal enables Ambu to serve a fifth of the acute care hospitals […]
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 […]
Ambu, Boston Sci execs see domination for single-use scopes
Hospital closures connected to COVID-19 have cut into the sales of many medical device companies, but executives at rival makers of single-use scopes say pandemic has only heightened existing concerns about contamination, exposure and cost. In interviews in this week’s DeviceTalks Weekly Podcast, executives from Ambu A/S and Boston Scientific (NYSE:BSX) said improved technology make […]
Ambu lands national single-use endoscope contract
Ambu announced that it was awarded a single-use endoscopy contract in the category of surgical disposable scopes with Premier Inc. Columbia, Md.-based Ambu said in a news release that it was also the only supplier of single-use endoscopes designated to participate in Premier’s Surpass and Ascend purchasing programs. The three-year agreement creates a single-use endoscopy […]
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 […]
Fractyl adds $55M Series E for Type 2 diabetes pivotal trial
Fractyl Laboratories secured $55 million for a Series E financing to continue funding a pivotal clinical trial of its potential non-drug, non-surgical treatment for Type 2 diabetes, according to the company. The capital will go toward the Lexington, Mass-based start up’s Revita T2Di pivotal clinical trial of Revita DMR (duodenal mucosal resurfacing). Revita is measuring […]
