Olympus (TYO:7733) said yesterday it inked a deal with InterSystems to enhance Olympus’ Knowledge Exchange System with InterSystems HealthShare, which allows for the sharing of images taken during endoscopy procedures. Olympus said its KE system is a software platform for centralized reprocessing record and image management that connects to its Olympus devices. The company added the […]
FDA warns against endoscope connectors
The FDA yesterday warned healthcare providers against using endoscope connectors in more than one patient without reprocessing, saying it hasn’t seen any acceptable tests demonstrating their safety. The federal safety watchdog said the connectors, which are used in more than one patient for gastrointestinal endoscopies over the course of 24 hours, connect the endoscope to […]
Cantel Medical wins FDA nod for Advantage Plus endoscope reprocessor
Cantel Medical (NYSE:CMD) said today it won FDA 510(k) clearance for its Advantage Plus pass-thru automated endoscope reprocessor, making it the first AER available in the US, the company claims. The newly cleared device is designed for the high-level disinfection of commonly used endoscopes, including duodenoscopes, the Little Falls, N.J.-based company said. “We strive to deliver real life […]
Funding Roundup: Swiss Advanced Vision seeks $21m for auto-focus IOL
FDA OKs limited duodenoscope sterilization by Custom Ultrasonics AERs
The FDA today announced that Custom Ultrasonics completed validation testing of its System Plus automated endoscope reprocessors, and that the devices are cleared for the reprocessing of certain duodenoscopes. With the clearance, the Philadelphia-based company’s line of System 83 Plus AERs are cleared for washing and disinfecting the Olympus (TYO:7733) TJF-180V and Pentax ED-3490TK duodenoscopes, according to an FDA […]
UPDATE: Moll’s Auris wins FDA nod for Monarch robotic endoscopy platform
Updated to include commentary from Auris chief strategy officer Josh DeFonzo. Auris Health, previously known as Auris Surgical Robotics and formed by Intuitive Surgical (NSDQ:ISRG) founder Dr. Frederic Moll, said today it won FDA clearance for its Monarch robotic endoscopy platform. The Redwood City, Calif.-based company said it’s Monarch robotic platform’s initial aim will be on […]
FDA issues warning letters to Olympus, Fujifilm, Pentax over duodenoscope issues
The FDA said today it issued warning letters to Olympus (TYO:7733), Fujifilm Holdings (TSE:4901), and Hoya‘s Pentax Medical over failures to comply with federal orders to conduct postmarket surveillance studies to assess the effectiveness of reprocessing duodenoscopes. The order, issued by the federal watchdog in 2015, required all three manufacturers to conduct postmarket surveillance studies to determine whether healthcare […]
Boston Scientific picks up EMcision
Boston Scientific (NYSE:BSX) said today that it built out its biliary offering with the acquisition of endoscope maker EMcision for an undisclosed amount. London- and Montreal-based EMcision makes the Habib EndoHPB probe, which is designed to coagulate tissue in the gastrointestinal tract in treating pancreaticobiliary cancers. Marlborough, Mass.-based Boston Scientific said the probe has 510(k) clearance […]
Motus GI wins CE Mark for Pure-Vu system
Motus GI said today it won CE Mark approval in the European Union for its flagship Pure-Vu system designed to clean poorly-prepped colons during colonoscopies. Approval was supported by positive results from a 47-patient European clinical study of the Pure-Vu system in cleaning poorly prepared colons, which showed an increase in the number of adequately cleansed […]
Three Rivers Medical wins CE Mark for Rio aneurysm embolization device
Three Rivers Medical said yesterday that it won CE Mark approval in the European Union back in October for its Rio embolization coil for treating brain aneurysms. Mountain View, Calif.-based Three Rivers said it also treated the first 10 patients with the Rio device, which is also CE Marked for peripheral embolizations. The company said it […]
Motus GI closes $18m IPO
Motus GI last week closed an initial public offering worth $18 million for its Pure-Vu system for intra-colonoscopy cleaning. Fort Lauderdale-based Motus said it plans to use the proceeds to commercialize Pure-Vu and for R&D, among other things. The company said it sold 3.5 million shares at $5 apiece, grossing $17.5 million, and also granted a 30-day […]
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