CardioFocus today announced a licensing and distribution agreement with China Grand Pharmaceutical to seek regulatory approvals for the HeartLight X3 catheter ablation technology in China. Marlborough, Mass.–based CardioFocus designed the HeartLight X3 system for controlled and consistent pulmonary vein isolation, which is the primary treatment … [Read more...] about CardioFocus, China Grand Pharmaceutical partner to commercialize catheter ablation system in China
Endoscopes
Pentax Medical Europe wins CE mark approval for single-use bronchoscope
Pentax Medical Europe today said it received CE mark approval for its single-use bronchoscope and is set to launch the device in Europe later this year. The Tokyo-based company designed the PulmoOne single-use bronchoscope to mimic the ergonomics of a reusable bronchoscope with similar scope handling and tip angulation that requires no change in … [Read more...] about Pentax Medical Europe wins CE mark approval for single-use bronchoscope
Boston Scientific gets CE mark approval for single-use bronchoscope
Boston Scientific today said it received CE mark approval for its Exalt Model B single-use bronchoscope. The Marlborough, Mass.–based company designed the device for bedside procedures in the intensive care unit, operating room and bronchoscopy suite. Exalt Model B is available in three sizes — slim, regular and large — for procedures such as … [Read more...] about Boston Scientific gets CE mark approval for single-use bronchoscope
FDA clears EndoFresh disposable digestive endoscope
EndoFresh today said it received FDA 510(k) clearance for its disposable digestive endoscopy system. The system features a camera system with an all-in-one design, disposable upper GI endoscope and disposable colonoscope, which can be used with the company's medical display and other peripheral devices for physicians to visualize, diagnose and … [Read more...] about FDA clears EndoFresh disposable digestive endoscope
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
