Sanovas files a 510(k) clearance application with the FDA for its Vas Zeppelin Smart Catheter, saying further applications are coming for its suite of pulmonary medical devices.
Sanovas said it's asked the FDA for 510(k) clearance for its Vas Zeppelin Smart Catheter, designed to diagnose and treat chronic pulmonary conditions and lung cancer.
The Sausalito, Calif.-based medical device company bills the device as "among the smallest interventional catheters," saying it's designed to "overcome the complexity and procedural risks associated with pulmonary intervention," according to a press release.
"This filing marks a significant milestone for Sanovas and beacons new opportunity for physicians and patients alike," CEO Larry Gerrans said in prepared remarks . "With 1 in 7 Americans suffering from chronic pulmonary disease and with lung cancer killing more people than breast, prostate and colon cancers combined, new technologies aimed at the earliest stages of lung disease are desperately needed."