FDAnews Device Daily Bulletin

TyRx Pharma has received an equity investment from Boston Scientific.

Biophan Technologies has been issued two new patents by the U.S. Patent and Trademark Office that extend the company's competitive edge in the marketplace for the rapidly emerging field of magnetic resonance imaging (MRI) safety and image compatibility for medical instruments and implanted devices.

Imaging Sciences International, a developer and manufacturer of advanced dental and maxillofacial radiography products, has announced that the International Organization for Standardization (ISO) has awarded ISO 9001:2000 and ISO 13485:2003 certifications to the company.

Radi Medical Systems, a designer and manufacturer of innovative devices in interventional cardiology, has announced the 510(k) clearance of the RadiAnalyzerXpress.

Syneron Medical and its North American subsidiary Syneron, an innovator in the development, marketing and sales of ELOS combined-energy medical aesthetic devices, have announced that in a recent meeting between senior company officials and representatives of the FDA, the FDA representatives stated it appears reasonable for Syneron to submit a 510(k) premarket notification to the FDA for marketing clearance of its VelaSmooth system in the U.S.

MDS Pharma Services, a provider of innovative drug discovery and development solutions, is the first contract research organization to adopt the new API 5000 mass spectrometer for small molecule quantification studies.

Cybernet Medical, a developer of biometric monitoring technology and medical devices for outpatient care, has announced its participation in a disease management research project with Foote Health System of Jackson, Mich.

Biomet, a maker of products for orthopedic surgery and joint repair, said that it plans to broaden the range of its bone cement offerings with the introduction of a product for use in minimally invasive surgery.

HealtheTech, a Colorado-based company that develops and markets technologically advanced and proprietary handheld medical and commercial devices and software for the measurement of metabolism and nutrition monitoring, has resolved its legal dispute with Microlife.

TransGenic has applied for a patent for its proprietary cancer diagnostic technology currently under development.

A Vancouver company has been awarded $1.4 million by NIH to conduct human clinical trials on a male contraceptive.

Medtronic has announced that CFO Robert Ryan will retire from the company at the end of this fiscal year, April 29. Gary Ellis, currently Medtronic vice president and corporate controller/treasurer, will succeed Ryan.

Biocoral has announced that recently the European Patent Office approved and granted a company patent called process for preparing a fibrin glue capable of coagulating by addition of calcium ions.

Chembio Diagnostics has completed a $5 million private placement with institutional and other accredited investors.