FDAnews Device Daily Bulletin

The FDA has cleared Roche's AmpliChip CYP450 test for diagnostic use in the U.S., the company announced.

The FDA has granted an investigation device exemption for enhancements to BSD Medical's BSD-2000 cancer treatment system.

Scandius BioMedical has launched the Stratis ST ACL Reconstruction System and Femoral Fixation Implant and reported that it has been successfully used in its initial surgeries since its recent FDA market clearance.

Inamed has filed a premarket approval (PMA) application with the FDA for Bio-Dimensional Cohesive Gel Matrix breast implants, designed for memory and shape retention.

Given Imaging, the global leader in capsule endoscopy, has announced that an economic analysis conducted by researchers at Thomas Jefferson University concludes that PillCam SB video capsule endoscopy is less costly from a payor perspective as a first line procedure for detecting small bowel Crohn's disease than traditional diagnostic procedures.

BSD Medical has announced that the International Journal of Radiation Oncology, Biology, Physics has published an article on the company's premier system, the BSD-2000/3D/MR.

Alliance Medical, which reprocesses single-use medical devices, has announced a two-year multisource agreement with HealthTrust Purchasing Group, a healthcare group purchasing organization.

Sensant, the leading developer of silicon-based ultrasound imaging technology, has received its first commercial order for its advanced Silicon Ultrasound imaging probes from Italian imaging systems manufacturer Esaote.

Addison-Davis Diagnostics (ADDI) has announced the appointment of Stark-SMO as ADDI's Site Management Organization.

Thoratec, a world leader in products to treat cardiovascular disease, has announced several additions and changes within the management team of its Cardiovascular Division, which includes all of the company's VAD (Ventricular Assist Device) and vascular graft product lines.

Medtronic has made an additional $250,000 available through the Medtronic Foundation for South Asia tsunami relief to match the generosity of its 32,000 worldwide employees.

Genyx Medical of Aliso Viejo, Calif., has announced the final closing of its agreement with C.R. Bard for the sale of Genyx to Bard for $60 million.