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 […]
Cook Medical partners with Ambu A/S to distro single-use duodenoscope pending FDA approval
Cook Medical said on Saturday that it inked a deal to partner with Ambu A/S to distribute its single-use, disposable duodenoscope devices once they receive FDA clearance. Bloomington, Ind.-based Cook Medical said that Ambu is currently developing the scope to help address infections caused by cross-contamination, as reusable scopes pose a contamination risk and have […]
FDA: Duodenoscope reprocessing is dirtier than we thought
The FDA said today that new data show that the contamination rate for “high-concern organisms” in duodenoscopes is nearly twice as high as previously thought and warned the devices three major manufacturers to get their required post-market studies in gear. Back in 2015 the federal safety watchdog warned Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary following a string […]
Apollo Endosurgery touts results of stomach-stapling study
Apollo Endosurgery (NSDQ:APEN) has reported key data from 1,000 patients who underwent endoscopic gastroplasty using the company’s OverStitch device. Published in the journal Gastrointestinal Endoscopy, the data include a mean total weight loss of 14.8%±8.5% at 18 months. Three months following surgery, the impact on obesity-related comorbidities included the complete remission of: 13 of 17 cases […]
FDA clears Rebound Therapeutics’ minimally invasive neurosurgical endoscope
Rebound Therapeutics has secured FDA 510(k) clearance for its Aurora Surgiscope system, which it touts as the first single-use disposable neurosurgical endoscope. The Aurora system enables minimally invasive access, visualization and illumination during neurosurgical procedures, the Irvine, Calif.–based company said yesterday. “Our physician advisors specified that we enable the complete neurosurgical procedure, without reliance on any […]
J&J may nab surgical robotics company Auris Health
Johnson & Johnson (NYSE:JNJ) intends to acquire surgical robotics company Auris Health, according to a report by Bloomberg News. In May 2018, Auris inked an agreement with J&J’s division Ethicon’s NeuWave Medical subsidiary to develop systems for the robotically-assisted bronchoscopic ablation of lung lesions. J&J has been working with Alphabet‘s (NSDQ:GOOGL) Verily Life Sciences on Verb Surgical’s prototype robot-assisted surgery […]
Olympus rejiggers medical biz
Olympus (TYO:7733) last week announced its plan to rejigger its medical device business with an eye toward gaining share in the U.S. market. The Japanese conglomerate weathered an accounting scandal in 2011 after firing its first foreign CEO, Michael Woodford, after he blew the whistle on unexplained payments worth around $1.7 billion and demanded the resignation of the former […]
Boston Scientific sues Micro-Tech over endo clip patents
Boston Scientific has filed a lawsuit against Micro-Tech USA and its Chinese manufacturer, Micro-Tech Nanjing, alleging that Micro-Tech infringed three of its patents for endoscopic hemostatic clips. Boston Scientific claims that Micro-Tech’s SureClip hemostasis clip products infringe the patents for its Resolution and Resolution 360 clips, which are designed to control gastrointestinal bleeding. Henry Schein (Melville, N.Y.) is […]
FDA clears NinePoint Medical’s AI-powered IRIS upgrade for Nvision VLE esophageal imager
NinePoint Medical said today that it won FDA 510(k) clearance for the Intelligent Real-time Image Segmentation software upgrade for its flagship Nvision VLE imaging system. The newly cleared IRIS is an artificial intelligence-based platform for image feature segmentation, the Bedford, Mass.-based company said. The company touted that the approval was the first of its kind for […]
ValenTx raises $10.3 million for implantable gastric bypass device
Startup ValenTx has attracted nearly $10.3 million from 32 investors, according to a filing with the Securities & Exchange Commission. The Maple Grove, Minn. company is developing a removable gastric bypass device as an alternative to Roux-en-Y gastric bypass surgery. It raised $10,271,050 in the round begun July 18, 2018. The ValenTx endoluminal bypass therapy mimics the attributes of […]
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