FDAnews Device Daily Bulletin

BioCare Systems has received 510(k) clearance from the FDA to market its PremlR818 Infrared Therapy device for the relief musculoskeletal pain associated with arthritis, neck/back pain, joint sprains and muscle strains.

The FDA has approved an expansion of Orqis Medical's clinical trial for the Cancion CRS therapy, a percutaneous cardiac recovery system being evaluated for its ability to reverse the consequences of abnormal aortic flow, induce vasodilatation and improve renal blood flow.

CryoLife and Endologix have entered into a development and marketing agreement for the percutaneous or endovascular delivery of CryoLife's BioFoam as a self-expanding sealant for endovascular aortic aneurysm grafts.

Becton, Dickinson and Co. has received FDA 510(k) clearance for its BBL CHROMagar product for the detection of methicillin-resistant Staphylococcus aureus (MRSA).

CPC of America reports that its subsidiary, Med Enclosure, has initiated the manufacturing and sterilization of its Rev "A" Internal Puncture Closure Device (MedClose) in preparation for launching a U.S. (IDE) clinical study.

Impliant, a developer of novel posterior motion-preservation and cartilage-protection devices for spine and joint arthroplasty, has secured more than $18 million in Series C financing from a group of leading financial and strategic investors.

A portable device similar to today's home pregnancy tests that can quickly detect the presence of infectious diseases, including HIV/AIDS and measles, as well as biological agents such as ricin and anthrax, is the object of a new joint university/industry research project.

FONAR has sold its FONAR 360 MRI to the Nuffield Orthopaedic Centre (NOC) NHS Trust in Oxford, England.

Power3 Medical Products, a leading proteomics company, announces the completion of the latest stage of clinical validation on the NuroPro, a neurodegenerative disease blood test used as a diagnostic tool in the early stage assessment of ALS and Alzheimer's, Parkinson's, and other diseases.

UTI, a world leader in integrated outsource manufacturing services to medical device companies, has changed its name to Accellent. In June, the company acquired Minneapolis-based MedSource Technologies, making the combined entity one of the world's largest medical device outsource manufacturing, design and engineering organizations, the company said.

Cardiac Science, a leading manufacturer of life-saving automatic public-access defibrillators (AEDs), announced that Rockville, Md.-based BAE Systems, one of America's foremost national security, aerospace and information systems companies, has purchased Powerheart G3 AEDs for 37 of its facilities nationwide.

InnoMed Technologies, a medical device company that markets products to treat sleep and respiratory disorders, has named Sanjay Chandran as its new CEO.