FDAnews Device Daily Bulletin

Cyberonics has announced that the FDA deemed the Vagus Nerve Stimulation (VNS) Therapy System approvable as a long-term adjunctive treatment for patients over the age of 18 with chronic or recurrent treatment-resistant depression (TRD) in a major depressive episode that has not responded to at least four adequate antidepressant treatments.

Medical devicemaker Medtronic recently said a federal district court reversed an earlier ruling that two of the company's stents violated a patent held by rival devicemaker Guidant.

PolyMedica has announced that its subsidiary Liberty Medical Supply acquired substantially all of the assets, excluding receivables, and the business of National Diabetic Assistance (NDAC).

Encore Medical has entered into a definitive agreement to acquire substantially all of the assets of Osteoimplant Technology (OTI), which will include a complete line of spinal implant products.

Homegrown medical devicemaker Biosensors International opened a cardiology facility in Singapore.

CryoLife, a biomaterials and biosurgical device company, has received accreditation from the American Association of Tissue Banks (AATB).

VisiJet, a developer of innovative technologies for the ophthalmic surgical market, has closed on a financing of $4.9 million.

IRIS International, a manufacturer and marketer of automated IVD urinalysis systems and medical devices used in hospitals and reference clinical laboratories worldwide, has entered into a supply agreement for its iQ200 Automated Urinalysis System and related products with Consorta, a leading healthcare resource management and group purchasing organization.

Perceptive Informatics, a subsidiary of PAREXEL International, has announced the expansion of its medical diagnostics business to include electrocardiography (ECG) core lab services through a new partnership with Medifacts.

Accelr8 Technology has been awarded U.S. Patent 6,844,028 for its OptiChem surface chemistry, a new coating that makes it possible to selectively capture, target and analyze individual bacteria, thus setting a new standard in rapid bacterial pathogen analysis.

Xenomics, a developer of next-generation molecular diagnostic techniques for medical and life sciences applications, has announced the closing of a private placement financing totaling $2.9 million.

Welch Allyn, a global manufacturer of frontline medical products and solutions, has introduced the Braun ThermoScan PRO 4000, the only electronic ear thermometer with a preheated probe and sensor for reliable temperature readings on patients of all ages.

Biophan Technologies, a developer of next-generation biomedical technology, has begun the integration of AMRIS operations into Biophan and expects to close all related paperwork within the next few weeks.