• Alliance Medical (Phoenix), a reprocessor of single-use medical devices, reported the FDA has cleared the final two 510(k)s filed by the company in response to the agency's supplemental validation submission request. The two clearances cover reprocessed electrophysiology (EP) catheters by Daig and EP Technologies. The company said the FDA's decision to grant Alliance the 510(k) clearance illustrates the company's compliance with the Medical Device User Fee and Modernization Act of 2002. Once reprocessed, the diagnostic EP catheters are intended to be used for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

• Bausch & Lomb (B&L; Rochester, New York) reported that the FDA has approved the single-indication orphan drug Retisert (fluocinolone acetonide intravitreal implant), 0.59 mg, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. B&L – which received FDA "fast track" status and orphan drug designation for the uveitis indication — said Retisert is the first intravitreal drug implant for the treatment of this sight-threatening inflammatory disease. The company said it is targeting a mid-year launch of the product. B&L's drug-delivery microtechnology in Retisert consists of a tiny drug reservoir designed to deliver sustained levels of the anti-inflammatory corticosteroid, fluocinolone acetonide, for about 2-1/2 years directly to the back of the eye.

• Biomoda (Albuquerque, New Mexico), a developer of cancer diagnostics, said it has completed the first clinical validation of CyPath, its development-stage assay for cancer. These results indicate CyPath's ability to differentiate lung cancer patients, heavy smokers and normal individuals. The cytology assay differentiates normal cells from abnormal cells, with the potential for identifying people with lung cancer and those at risk for developing lung cancer, the company said. CyPath is a product developed from technology licensed from the University of California and from Biomoda's own technology. The company said additional R&D is focused on addressing bladder and cervical cancers, and is currently collecting new samples to further validate the predictability of the assay for early detection of cancer.

• Cambridge Heart (Bedford, Massachusetts) reported that it has received FDA clearance to begin marketing in the U.S. of its new Heartwave II System for the measurement of Microvolt T-Wave Alternans (MTWA), and that the product is now available. The Heartwave II System is a stand-alone device to measure MTWA to help predict an individual's risk of sudden cardiac death. Unlike the original Heartwave System, the Heartwave II does not require a host stress exercise system to control the treadmill or to monitor the patient's ECG (electrocardiogram) or electrical activity of the heart. Running on a Microsoft Windows XP operating system, the look and feel of the Heartwave II is more familiar for the user, the company said. The Pentium processor included in the Heartwave II can process information up to 15 times faster than the original Heartwave, and its increased memory capacity can store 300 times more patient studies.

• FzioMed (San Luis Obispo, California), which is developing products for the prevention of post-surgical adhesions, tissue augmentation and regeneration, and the delivery of drugs, said that it has been awarded a new U.S. patent covering its Oxiplex technology. Oxiplex is a versatile polymer biomaterial developed by FzioMed for use in a variety of surgical specialties. Patent No. 6,869,938 covers compositions of polyacids and polyethers, and methods for their use in reducing post-surgical adhesions.