Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
- Carestream Health wins final FDA approval for CR mammography system
Carestream Health has received final approval from the U.S. Food and Drug Administration for its computed radiography system for mammography. The company has begun commercial distribution of this mammography CR system in the U.S.
- Medtronic wins 510(k) for spinal cord stimulation trialing cable
Medtronic Inc. (NYSE:MDT) announced Food & Drug Administration clearance and the global launch of the Multi‐Lead Trialing Cable for use in the patient screening test for Medtronic spinal cord stimulation therapy. Introduced this month in the U.S., Europe and Canada, the streamlined trialing system allows physicians to test a wide array of stimulation settings prior to implanting a neurostimlator to provide long‐term pain management.
- FDA clears Volpara breast imaging software for automatic calculation of volumetric breast density
Volpara Ltd. announced that it received clearance from the Food & Drug Administration for its Volpara breast imaging software. Volpara, a subsidiary of Matakina Technology Ltd. of New Zealand, is responsible for commercial operations in the U.S.
- Ethicon Submits Biologic License Application to the FDA for the Fibrin pad
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Inc. announced the submission of a biologic license application to the Food & Drug Administration for the Fibrin pad, a combination of Ethicon’s biomaterials and plasma-derived biologics (human fibrinogen and human thrombin), to aid in stopping soft tissue bleeding during surgery.
- BG Medicine announces FDA 510(k) clearance of its Galectin-3 test for chronic heart failure
BG Medicine Inc. announced that the Food & Drug Administration cleared its Galectin-3 test for use in conjunction with clinical evaluation as an aid to assess the prognosis of patients diagnosed with chronic heart failure. This marks the first time the FDA has cleared a test to measure galectin-3 blood levels and is the first novel cardiac test cleared by the FDA in five years.
- American Scientific Resources becomes approved ISO manufacturer
American Scientific Resources Inc. (OTC:ASFX) announced that it is officially an approved manufacturer of medical devices under the International Organization for Standardization, the world’s largest developer and publisher of international business standards.
- Imaging Diagnostic Systems announces 510(k) filing
Imaging Diagnostic Systems Inc. (OTC:IMDS) announced that a premarket notification 510(k) was submitted Nov. 22 to the Food & Drug Administration. With this submission, the company moves forward in the process of seeking marketing clearance for its innovative breast imaging device, the CTLM system.