Masimo (NSDQ:MASI) landed FDA 510(k) clearance to expand its pulse oximeters and neonatal sensors to screen newborns for signs of critical congenital heart disease.
510(k)
Aptus Endosystems lands FDA nod for abdominal aneurysm device
FDA news: Covidien, Preventice, Precision Spine win FDA clearances
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
Covidien (NYSE:COV) said it won 510(k) clearance from the FDA for its LigaSure surgical sealer/divider for ear, nose and throat procedures.
Heart pumps: Abiomed gets FDA win for Impella CP
Abiomed (NSDQ:ABMD) is touting a regulatory win for its Impella CP heart pump.
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.
FDA grants Zynex 510(k) clearance for female incontinence device
Colorado-based device maker Zynex (OTC:ZYXI) won FDA clearance for its InWave device, an electrotherapy system for treating female urinary incontinence.
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.
FDA win is Irish startup’s introduction to gastroenterology
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.
FDA clears pressure-injectable catheter insertion systems by Flexicath
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.
AngioDynamics touts FDA win for “disruptive” clot-reducing catheter
AngioDynamics (NSDQ:ANGO) won FDA clearance for its BioFlo peripherally-inserted central catheters, the company announced this week.
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.
Toshiba touts another win for next-gen Aquilon imager
Toshiba Medical Systems (TYO:6502) American medical products division won FDA clearance for the company’s newest model Aquilon CT scanner, the RXL Edition.
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.
FDA hands rehab devices startup Hollywog 2 wins for wireless back pain systems
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 wins FDA nod for battery-powered iDrive Ultra surgical stapler
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.