DSM PTG, part of DSM Biomedical, has announced the availability of Bionate® II PCU, a versatile medical polymer with built-in surface technology designed for chronic implants. Bionate® II PCU is a line extension of the well known Bionate® Polycarbonate Urethane family, one of the industry’s leading medical polymers for long-term implants and is backed by an established FDA Master File. The new polymer offers improved performance and processing characteristics for medical devices.

Ortho Clinical Diagnostics received the FDA approval of a diagnostic assay for the detection of antibodies to human immunodeficiency virus (HIV) types 1+2 (Anti-HIV 1+2) for use on the VITROS® 5600 Integrated and VITROS® 3600 Immunodiagnostic Systems. This is the first HIV diagnostic assay approved for an integrated system in the US, allowing laboratories to run HIV and other routine tests on a single testing platform and eliminating the need for expensive batch testing of multiple patient samples.

SpectraScience Inc has received FDA approval for the WavSTAT System. The system is the first commercially available product that incorporates this innovative technology for clinical use. WavSTAT is indicated for use as an adjunct to lower gastrointestinal (GI) endoscopy and is intended for the evaluation of polyps less than one centimeter in diameter, which the physician has not already elected to remove.

The FDA has approved a test for women who have developed tumors in the pelvic region known to need surgery. The test, OVA1, will be helpful for doctors in deciding if the tumor is an ovarian cancer and what should be their procedure to advance towards surgery. OVA1 can even detect ovarian cancer in women who have received negative results from standard cancer tests. The test, which has been developed by Vermillion Inc in collaboration with scientists at The Johns Hopkins University in Baltimore, can also identify women whose surgical cases will benefit from the involvement of a gynecological oncologist.

The FDA has approved a portable polymerase chain reaction (PCR) testing device, which can be used by military doctors to diagnose novel H1N1 flu infections in troops stationed overseas. The device, called (Joint Biological Agent Identification and Diagnostic System), is a rugged, suitcase-sized instrument that can run PCR-based molecular diagnostic tests. It has been under development for several years by a consortium of military health research centers, the CDC and academic medical laboratories.

Medtronic Inc announced the approval of its Attain Ability left-heart lead (Model 4196) by the U.S. Food and Drug Administration (FDA) for use with cardiac resynchronization therapy (CRT) devices for heart failure patients. Attain Ability has the thinnest lead body of any left-heart lead currently available, providing physicians with a tool to deliver therapy directly to hard-to-reach areas of the heart.

Ortho Clinical Diagnostics announced 510(k) clearance from the United States Food and Drug Administration (U.S. FDA) for its VITROS(R) 3600 Immunodiagnostic System. This new high-capacity immunoassay system provides laboratories with a truly innovative solution to address their quality, labor and cost challenges. The VITROS(R) 3600 delivers high-quality and dependable results by offering a broad and comprehensive immunoassay menu based on world-class VITROS(R) technologies. This is the second clearance for Ortho Clinical Diagnostics this quarter, following 510(k) clearance of the VITROS(R) 5600 Integrated System in October.

The U.S. Food and Drug Administration has cleared the Tosoh G8 which offers pinpoint precision with the industry’s lowest CVs of less than 2%. The instrument-reagent system uses the gold standard ion-exchange method of HbA1c levels testing to monitor glycohemoglobin in diabetic patients effectively. The system’s automatic start-up and touch-screen operation make it very user-friendly. Also, it fits in most of the laboratory environments easily. The G8 is a diagnostic system for measurement of HbA1c in samples of blood.

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to MiCardia Corporation for marketing its Dynaplasty™ Annuloplasty Band DR™ and Annuloplasty Ring DR. These are the company’s first  Dynaplasty technology products to receive this clearance. Welcoming this approval MiCardia CEO, Paul Molloy commented that it involved extensive technical validation of the Company’s first generation annuloplasty system. He said, “It prepares the way for the progression of this highly unique and innovative Dynaplasty Technology and pairs with the commencement of the Company’s DYANA Phase I human study in Europe”.

The PreMD’s appeal over the NSE (not substantially equivalent) letter it received for a premarket submission to expand indications for its skin cholesterol test has been upheld by the FDA.  The FDA agreed that the clinical trial data was not sufficient to say if the product was substantially equivalent to other markers of cardiovascular risk.