FDAnews Device Daily Bulletin

Medical device company Haemonetics has reported the FDA cleared its CardioPAT surgical blood salvage system.

Ethicon has announced the results of a study demonstrating that the company's ULTRAPRO Partially Absorbable Lightweight Mesh provides high initial burst strength during the critical time period of tissue-mesh incorporation.

Biophan Technologies, a developer of next-generation biomedical technology, entered into a letter of intent to acquire a leading German-based developer of magnetic resonance imaging (MRI)-safe and image-compatible technology solutions and biomedical devices.

Biofield, developer of the Biofield Breast Proliferation Rate Detection System (BDS) -- a noninvasive, radiation-free adjunctive test system that may be of assistance in the evaluation of suspicious breast lesions -- has submitted a petition to the FDA requesting reclassification of the BDS.

NIR Diagnostics, a leading-edge developer of near-infrared diagnostic instruments, has received a $1 million payment as a result of a licensing agreement between Spectromedical, of Cambridge, Ontario, and a third-party licensee.

DOBI Medical International has expanded its international presence by signing new distribution agreements with Biomedica Life Sciences in Athens, Greece, and Nova-Logic in Montreux, Switzerland, for the DOBI Medical ComfortScan system.

Microlife launched the first digital peak flow meter that also provides FEV-1 measurement through its first major retail chain partner.

I-Flow announced that Volker Jacobs and John Morrison of the Fayette Medical Center (FMC) presented data highlighting benefits of ON-Q PainBuster to reduce pain after mastectomy while reducing or eliminating the use of narcotics at the San Antonio Breast Cancer Symposium in December.

Medical device company American Bio Medica has said that the FDA cleared its Rapid TEC4 drugs of abuse test and also received a Canadian patent related to its rapid drug screen product.

CryoFluor Therapeutics, a medical device company developing a novel cryosurgical technology platform, has received a second investment that will allow the company to complete a feasibility clinical trial of its device to treat abnormal uterine bleeding.

RITA Medical Systems has announced its wholly owned subsidiary Horizon Medical Products entered into an agreement allowing it to repay $6.5 million in debt held by creditors of Horizon.

AMDL, developer and marketer of tests for the early detection of cancer and other serious diseases, has announced its consultant, Diagnostic Oncology Clinical Research Organization, submitted to the FDA, on behalf of AMDL, additional data and a new application for 510(k) clearance to market AMDL's DR-70 test as an aid in monitoring patients previously diagnosed with progressing colorectal cancer.

Nanogen, developer of advanced diagnostic products, has announced the appointment of Robert Saltmarsh as CFO. Saltmarsh joined Nanogen as vice president of corporate development last September.

Recom Managed Systems, in conjunction with the Duke Clinical Research Institute, of Durham, N.C., has announced its Sponsored Research trial is underway.