FDAnews Device Daily Bulletin

The Centers for Medicare & Medicaid Services (CMS) issued a final decision that would immediately expand coverage of carotid artery stenting for high-risk patients with symptomatic narrowing of carotid artery of 70 percent or more.

Siemens and CTI Molecular Imaging have entered into a merger agreement under which Siemens will acquire CTI for approximately $1 billion.

Biophan Technologies, a developer of next-generation biomedical technology, has been issued Patent No. 6,864,418, "Nanomagnetically Shielded Substrate," by the U.S. Patent and Trademark Office.

Advanced Research Technologies (ART) has obtained authorization from Health Canada's Therapeutic Products Directorate to begin its pivotal clinical study in Canada for its SoftScan optical breast imaging system.

Candela announced that it has received approval from the Japanese Ministry of Health to sell its GentleYAG laser throughout Japan.

QTL Biosystems announced the introduction of its Universal Development Kit for Kinase and Phosphatase Assays following the release of additional Serine/Threonine and Tyrosine Kinases.

The University at Buffalo (UB) has signed an agreement with Sleep Solutions, the medical device and healthcare services company providing direct-to-patient testing services, to commercialize and distribute an innovative diagnostic testing technology for Obstructive Sleep Apnea and Cheyne-Stokes Respiration.

American Bio Medica (ABMC) announced that it has signed a distribution agreement with MAVAND Solutions.

The biotech company SIRS-Lab and the Oxford Gene Technology IP have agreed on the licensing of OGT's technology for nucleotide-based biochips.

Maxxon announced the appointment of Ron Wheet to chief executive officer (CEO).

Aurilink has developed a "ready-to-wear" sound amplifier for individuals who want and need occasional hearing assistance due to mild hearing loss.

Baxa announced the addition of four specialty administration sets to the MicroFuse Syringe Infusion System line. These new sets incorporate a T-site for the convenient administration of coronary vasodilators during myocardial perfusion imaging.

Kensey Nash previously announced on Feb. 7 that the company had submitted a response to the FDA comments focused on labeling and clarification of previously submitted data in its submission for 510(k) clearance of the triActiv System.