Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
- X-spine wins FDA 510(k) clearance for Axle spinal fusion system
X-spine, a global manufacturer of implants and instruments for spinal surgery, announced FDA clearance of its new AXLE™ Interspinous Fusion System. The system is designed to provide spinal stability for lumbar fusion procedures, including the treatment of degenerative disk disease, spinal tumors and trauma.
- Elekta receives FDA 510(k) clearance for XiO Software to plan spot scanning for proton therapy
Elekta recently received 510(k) clearance from the U.S. Food and Drug Administration for its XiO® treatment planning software to plan spot scanning. Spot scanning is a proton therapy delivery method that involves constructing a highly conformal dose to the tumor by using thousands of small individual beamlets instead of a single large beam. This approach enables Intensity Modulated Proton Therapy (IMPT).
- FDA clears influenza and respiratory virus test kit from Quest Diagnostics’ Focus Diagnostics business
Quest Diagnostics Inc. (NYSE:DGX), the world’s leading provider of diagnostic testing, information and services, announced that the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance to the Focus Diagnostics Simplexa Flu A/B & RSV test on the 3M™ Integrated Cycler. The Simplexa test, developed and manufactured by Quest Diagnostics’ Focus Diagnostics business, is intended as an aid in the detection and discrimination of influenza A, influenza B and RSV virus infections.
- Syneron announces U.S. and Canada launch of CO2RE system following FDA and Health Canada clearance for the system
Syneron Medical Ltd. (NSDQ:ELOS), the global leader in the medical aesthetic device marketplace, announced the US Food and Drug Administration (FDA) and Health Canada clearance and commercial launch of its highly flexible CO2RE CO2 resurfacing system. CO2RE is a versatile fractional CO2 system that offers the unique ability to treat both superficial and deep skin layers simultaneously with precision-control over the intensity, pattern and depth of ablation.
- Gen-Probe files U.S. regulatory application for APTIMA® HPV assay
Gen-Probe Incorporated (NSDQ:GPRO) announced that the company has submitted a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) for its APTIMA® HPV (human papillomavirus) assay, a new molecular test that detects high-risk HPV infections that are associated with cervical cancer and precancerous lesions.
- Neuro Kinetics earns approval from Health Canada to sell diagnostic devices in Canada
Neuro Kinetics Inc. manufacturers of noninvasive medical diagnostic equipment used worldwide to test for vestibular and neurological conditions, said that it has been granted a license from Health Canada to sell three of its devices in Canada for clinical use.
- FDA approves Merit Medical’s HiQuality clinical trial protocol for the treatment of primary liver cancer
The Food and Drug Administration (FDA) has approved Merit Medical Systems, Inc.’s (NSDQ:MMSI) phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere(TM) Microspheres (hqTACE) for delivery of doxorubicin. The clinical trial will involve U.S. and international interventional radiologists who treat patients with localized, unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer.