FDAnews Device Daily Bulletin

Thoratec said that the first patients have been enrolled in the destination therapy and bridge-to-transplantation arms of the Phase II pivotal trial for its HeartMate II LVAS (left ventricular assist system) device.

Immunicon announced that the CellTracks Analyzer II was cleared by the FDA for in vitro diagnostic (IVD) use through the 510(k) premarket notification process.

The FDA gave clearance to medical device manufacturer Suros Surgical Systems to provide partial or complete removal of breast tissue with the ATEC breast biopsy system.

Pearsalls, a UK-based medical device company, announced the early clinical results of its novel artificial cervical disc implanted in nine patients at the Royal Orthopaedic Hospital in Birmingham, England.

Iceland Genomics (IGC), a privately held company, and Roche Diagnostics, Basel, Switzerland, entered into a cancer biomarker discovery collaboration.

The Yediot Ahronot Hebrew daily reports that negotiations to settle the bitter dispute between Israel stent manufacturer Medinol, owned by Kobi and Judith Richter, and U.S. company Boston Scientific, Medinol's former partner, have reached an advanced stage.

BioMérieux announced it has received FDA approval for commercial sales and marketing of the VITEK 2 Compact, an automated bacterial identification and antibiotic susceptibility testing system.

AcroMetrix announced that it has signed an agreement with Ambion Diagnostics, a division of Ambion, to manufacture Armored RNA-based products and distribute them to in vitro diagnostic laboratories and manufacturers.

Cellectricon, a Swedish biotechnology company and a leading provider of cell-based assays, announced that Scientifica will distribute the Dynaflow System for ion channel drug discovery in the UK.

Medical device incubator and technology brokerage firm, Hatch Medical, announced it has signed an exclusive, worldwide license agreement with physician inventor, J. Kevin McGraw for his patent-pending percutaneous spinal stabilization system.

Medical Home Products, a provider of medical self test kits and diabetics supplies, announced that the company has issued a letter of intent (LOI) to acquire an established diabetic supply company.

Beckman Coulter introduced Cell Lab Quanta, a new flow cytometry solution for affordable cellular analysis in research and drug discovery applications.

VisiJet is rebranding the company and will now be doing business as Advanced Refractive Technologies.