A trio of medical device companies won nods from the FDA’s Center for Devices & Radiological Health this week, including a surgical sealer, a wireless cardiac monitor and a spinal plating system
The Danvers, Mass.-based medical device company said it landed 510(k) clearance from the FDA for the percutaneous, catheter-based heart pump, which it says can provide peak flows of 4 liters per minute, about 80% of what a healthy heart can pump.
The company’s hoping that the InWave device will complement its existing electrotherapy portfolio and spur a boost in revenue, CEO Thomas Sandgaard said in a press release.
Irish medical device maker Crospon entered the gastroenterology market with FDA clearance to expand its EndoFlip imaging device to esophageal procedures.
The EndoFlip device is a functional lumen imaging probe used to measure the dimensions and function of hollow organs.
The system was previously cleared for use in during gastric band and sleeve gastrectomy bariatric surgery.
The FDA awarded 510(k) clearance to Flexicath for its pressure injectable M/29 Midterm catheters, the company announced last week.
The Pittsburgh-based catheter insertion systems maker aims to address "blood stream infection control issues" with its devices, according to a press release.
BioFlo is AngioDynamics’ 1st device to include the proprietary Endexo technology for reducing the accumulation of blood clots on and in the catheter, according to a press release.
The new scanner features "the most advanced radiation dose reduction technology" as well as sophisticated algorithms for reducing noise while maintaining image quality, according to a press release.
Rehab and physical therapy devices startup Hollywog landed a pair of FDA nods for its wireless back pain therapy devices, the WiTouch and the WiTouch Pro.
The devices use transcutaneous electrical nerve stimulation, a process in which electrical signals are transmitted through the skin to stimulate nerve or muscle fibers, to suppress pain signals before they they reach the brain and ramp up the body’s production of pain-relieving endorphins, according to the company’s website.
Covidien (NYSE:COV) touted FDA clearance for its iDrive Ultra Powered surgical stapler, which the company calls the only fully powered, reusable, battery-operated endoscopic surgical stapler in the world.
The iDrive Ultra is the 2nd in Covidien’s line of powered stapling devices and the 1st to fit all of the device maker’s Endo GIA staple reloads, according to a press release.