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Diamics, Inc., a San Francisco Bay-area, medical device and diagnostics company, announced it has submitted a 510(k) premarket notification application to the FDA for its proprietary CerCol cervical collection device.
All heparin-containing flush solutions, regardless of when they first appeared on the U.S. market, will be regulated "under the device provisions" of the Federal Food, Drug, and Cosmetic Act, FDA announced.
A cardiologist was released Aug. 17 from his position at the Cleveland Clinic after it was discovered he had failed to disclose his financial interests in a stroke-prevention product, according to reports.
The Centers for Medicare & Medicaid Services (CMS) Aug. 15 published new quality standards for suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) with revisions it says will make the regulatory process easier for industry.
Cambridge, Mass.-based Correlagen Diagnostics Inc. has introduced an automated genetic testing system for hospital-based clinical diagnosis laboratories.
DexCom Inc., a development stage medical device company, revealed that the U.S. District Court for the District of Delaware granted the company's motion to stay the patent infringement case brought against it by Abbot Diabetes Care Inc., a subsidiary of Abbot Laboratories Inc., and added that the court dismissed one significant claim in Abbot's lawsuit.
Industrial spectroscopy innovator Ometric Corporation has successfully installed and implemented the first upgrade of its patented SpectrInline Processware.
Cook Urological, a division of Cook, the world's largest private medical device company, Aug. 17 announced the availability of the FlexorDL (Dual Lumen) Ureteral Access Sheath and the BiWire Nitinol Core Wire Guide to advance the treatment of urological diseases.
DNAPrint Genomics, Inc. announced that it has entered into an agreement that will enable the Center for Medical Genomics, Emory University Department of Human Genetics to utilize the Company's Ancestry Informative Marker testing package, including all the materials necessary to complete a genetic ancestry profile under guidelines established by the College of American Pathologists (CAP).