FDAnews Device Daily Bulletin
Feb. 28, 2005 | Vol. 2 No. 41
A complaint was filed against Hewlett-Packard (HP) and its spin-off, Agilent Technologies, by a former employee, citing a "scheme to defraud its customers by knowingly selling defective and potentially dangerous medical devices."
Cook Biotech and CorMatrix Cardiovascular have announced a cross-license agreement to encourage the development of certain cardiovascular medical devices using proprietary extracellular biomaterials held by each company.
Medtronic announced the European introductions of the Medtronic EnRhythm pacemaker (dual-chamber) and the Medtronic EnTrust implantable cardioverter-defibrillators (ICDs) (single- and dual-chamber versions).
Biophan Technologies, a developer of next-generation biomedical technology, announced completion of the acquisition of a majority interest in AMRIS, bringing Biophan exclusive access to key patents in magnetic resonance imaging (MRI) technology.
Restore Medical, a provider of medical technologies to address sleep-disordered breathing, announced that the Pillar Palatal Implant System has received CE Mark certification for OSA and is now cleared for use in Europe.
A business unit of Warwick, R.I.-based MultiCell Technologies has been granted a U.S. patent on its Sybiol synthetic bio-liver device.
Medical Services International has been asked to participate in two additional testing programs with its VScan TB test kits.
Candela has received clearance from the FDA to market its family of pulsed dye lasers for the treatment of benign epidermal pigmented lesions adding to the previously cleared treatments of facial veins, rosacea, leg veins, port wine stains, scars, wrinkles, psoriasis, stretch marks and warts.
Conceptus, developer of the nonincisional permanent birth control procedure Essure, announced that it has submitted a premarket approval (PMA) supplement to the FDA to extend effectiveness data on the Essure product labeling.
Griffin Laboratories, a California designer and manufacturer of medical devices for speech pathologists, upgraded from AutoCAD LT to 3D with Alibre Design to expedite design-to-manufacturing cycles and improve communications with suppliers.
Medtronic has announced the latest expansion of its industry leading system of poly-axial screws, hooks and rods and other internal fixation devices used in spinal fusion surgery.
Mediware Information Systems announced that it has submitted its next generation donor management system, HCLL Donor, to the FDA for 510(k) clearance.
The FDA recently approved a new medical device for prostate biopsies and improving the accuracy of less-invasive cancer treatments.
Akers Biosciences announced that it has signed an agreement establishing an alliance with Alco Industries to distribute certain of Akers' rapid diagnostic tests to U.S. retail markets.
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