FDAnews Device Daily Bulletin
April 4, 2005 | Vol. 2 No. 66
Hypoguard, a manufacturer and marketer of blood glucose monitoring systems, announced that it recently received clearance from the FDA that will allow people using the Advance Micro-draw blood glucose system to use alternate site testing when checking their blood glucose level.
The first patient in the U.S. to be enrolled in the clinical trial called, "Carotid Angioplasty and Stenting vs. Endarterectomy in Asymptomatic Subjects with Significant Extracranial Carotid Occlusive Disease Trial," (ACT I) was treated at the Hoag Heart and Vascular Institute at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif.
Siemens Hearing Instruments has introduced iScan, an in-office ear impression scanner that allows hearing care professionals to scan ear impressions in their office and then send the custom product order, including the digital impression, electronically to the manufacturer for production.
OmniCorder Technologies announced that the Centers for Medicare & Medicaid Services (CMS) has established a new technology Ambulatory Payment Classification (APC) for the company's BioScanIR System -- a medical imaging modality that provides a fast, noninvasive, radiation-free method for detecting and managing a wide variety of diseases that affect blood perfusion -- for U.S. Medicare patients in an outpatient hospital setting.
Plastic components maker Cascade Engineering is diving into the fast-growing medical market.
HemoSense announced its filing of a registration statement with the Securities and Exchange Commission (SEC) for a proposed initial public offering of shares of its common stock.
A recent medical convention at the Granvia Hotel in Wakayama, Japan, marked the commencement of marketing and sales for Current Technology's patented TrichoGenesis platform in the world's second largest national economy, Japan.
Milestone Scientific announced that it has entered into binding subscription agreements for an approximately $3 million private placement of 101,044 units to institutional accredited investors.
Eye-surgery instrument maker iScience Surgical said it raised $15 million in its series C round of venture funding.
Vital Images, a provider of enterprise-wide advanced visualization software, and Toshiba Medical Systems, headquartered in Tochigi, Japan, have agreed to renew their U.S. and international marketing and distribution agreement for two years, through 2006.
Bayer confirmed it has completed its previously announced transaction to contribute the assets of its worldwide plasma products business to Talecris Biotherapeutics, a newly formed corporation controlled by affiliates of Cerberus Capital Management, New York, and Ampersand Ventures, Wellesley, Mass.
MedCap announced that its AccuScan Heroin/Morphine test kit has been given experimental status for testing purposes and is being used in several hospitals in the Beijing area as well as being used by law enforcement agencies for testing individuals who are known to use illegal substances.
Lumenis -- a global developer, manufacturer and seller of laser and light-based devices for medical, aesthetic, ophthalmic, dental and veterinary applications -- announced a new global strategy for expanding the dental segment of its medical laser business.
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