Here’s a roundup of companies announcing regulatory clearances from the Food & Drug Administration and foreign regulatory agencies:
- PinPointe FootLaser receives FDA clearance for the treatment of nail fungus
PinPointe USA, Inc., a leader in podiatric light-based therapy, announced today the PinPointe FootLaser received clear ance from the U.S. Food & Drug Administration for the treatment of nail fungus, onychomycosis. During the procedure, which is administered by podiatrists, a specially-designed laser beam is directed across the nail. The laser penetrates the nail bed targeting the fungi responsible for the infection, while leaving the nail and surrounding healthy tissue intact.
- TransEnterix Spider Surgical System receives CE Mark
The TransEnterix Spider Surgical System, an innovative platform that allows a surgeon to operate through a patient’s belly button, has received regulatory approval to market in the European Union.
- AutoGenomics Receives FDA Clearance for its Infiniti CYP2C19 assay
AutoGenomics, a leader in providing automated, molecular testing solutions announced today that it has received 510(k) clearance from the Food & Drug Administration to market its Infiniti CYP2C19 Assay. The test detects 3 genetic variants, *2, *3, *17, of the CYP450 2C19 gene and is to be used on the company’s automated molecular testing platform, the Infiniti Analyzer.
- ArthroCare receives FDA clearance for Spartan PEEK suture implant
ArthroCare Corp. (NSDQ:ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, announced today that it has received clearance from the Food & Drug Administration for its Spartan PEEK suture implant system. Spartan is a preloaded PEEK threaded anchor indicated for use in fixation of soft tissue to bone, such as during a rotator cuff repair.