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.
Read more - 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.
Read more - 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.
Read more - 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.
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