FDAnews Device Daily Bulletin

The University of Medicine and Dentistry of New Jersey has announced an expansion in scope of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) study to include asymptomatic participants, and the addition of participating trial sites from 70 to 110.

SpineVision has received FDA clearance to market its PediGuard instrument as an FDA Class II device, making it the first and only FDA-cleared device for real-time detection of possible penetration outside the vertebral pedicle, the company said.

Thoratec has said the FDA granted approval of its investigational device exemption for the company to begin a Phase II pivotal clinical trial for the HeartMate II LVAS (left ventricular assist system).

CrossCart, a private medical device company focused on the development, manufacture and commercialization of animal-derived tissue products for humans, has received clearance from the FDA to initiate a pivotal trial for its lead product, a porcine-derived ligament known as the Z-Lig.

Nihon Kohden has announced that it has signed a sales agreement with Abbott Laboratories of Illinois for automated hematology diagnostic instruments.

Biosite, a research-based provider of novel, rapid medical diagnostics, announced the FDA has notified the company that the agency has accepted the Triage Stroke Panel premarket approval application (PMA) for further review.

CONMED has announced that its orthopedic business unit, ConMed Linvatec, a leader in sports medicine technology, will be launching seven new products at the annual conference of the American Academy of Orthopaedic Surgeons (AAOS) in Washington D.C., Feb. 23-25.

Medical Carbon Research Institute (MCRI) has announced the approval of the On-X Prosthetic Heart Valve by the Japanese Ministry of Health, Labor and Welfare.

Tissue engineers can choose from a wide range of living cells, biomaterials and proteins to repair a bone defect. But finding the optimum combination requires improved methods for tracking the healing process.

Diabetic Treatment Centers of America (DBTC) has announced the execution of a letter of intent to acquire Movement Disorder Technologies.

LDR Spine, which has developed implantable systems that make it easier to perform spine surgeries, has gotten clearance from the FDA to market two fusion spine products in the U.S.

Novoste announced that its board of directors has determined that its vascular brachytherapy (VBT) business is no longer viable and, as a result, has authorized a staged, wind-down of the business.

MIV Therapeutics and SagaX Medical Technologies announced that they have entered into a letter of intent regarding SagaX's next generation embolic-protection technology for stroke patients.