• Abbott Molecular (Des Plaines, Illinois) and Celera (Rockville, Maryland) reported that Abbott has received FDA approval to market the Abbott RealTime HIV-1 viral load test for use on the company's m2000 automated instrument system. The assay is designed to detect and precisely measure levels of HIV circulating in a patient's blood (viral load), including the three major groups of HIV-1 as well as non-B subtypes. It is intended for use as a marker of disease prognosis and an aid in assessing viral response to antiretroviral treatment. The m2000 system consists of two instruments: the Abbott m2000sp and the m2000rt. The system's computer software links an instrument that automates the extraction, purification and preparation of DNA and RNA from patient samples (m2000sp) with a real-time PCR instrument that amplifies, detects and measures minute levels of infectious agents (m2000rt). Celera is primarily a molecular diagnostics business that is using genomics and proteomics discovery platforms to identify and validate novel diagnostic markers. Celera has an alliance with Abbott for the development and commercialization of molecular, or nucleic acid-based, diagnostic products. Abbott Molecular, a division of Abbott, is specializes in molecular diagnostics.

• Biomet (Warsaw, Indiana) reported that Biomet Orthopedics recently received FDA clearance for its acetabular hip liners manufactured from E-Poly Highly Crosslinked Polyethylene. E-Poly liners are vitamin E stabilized highly crosslinked polyethylene products to be introduced to the market. In laboratory testing, E-Poly liners have demonstrated 95%-99% less wear than the existing low wear rates of Biomet's clinically successful ArCom polyethylene liners, according to the company. The E-Poly material also provides greater strength when compared to first generation re-melted highly cross-linked polyethylenes, while maintaining optimal oxidation resistance. Biomet makes products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy.

• Generic Medical Devices (GMD; Gig Harbor, Washington) reported FDA clearance of its Universal Surgical Mesh, the company's second 510(k) clearance for a medical device to be sold as a generic alternative to existing surgical products. The GMD Universal Surgical Mesh is a Class II, non-active implantable medical device used to support tissue growth in open or laparoscopic procedures, common for hernia repair. Clearance of the GMD Universal Surgical Mesh is based on the device being substantially equivalent to pre-amendment devices and a product currently on the market. GMD leverages expired patents on standard-of-care surgical devices that have undergone few, if any, changes since first being introduced to the market. GMD says that its devices all have "existing 510(k) classification, reimbursement by Medicare and third-party payors, established product safety, efficacy and outcomes, and a trained surgeon/physician base."

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