FDAnews Device Daily Bulletin
April 1, 2005 | Vol. 2 No. 65
Moria has announced that the Epi-K, the company's disposable epikeratome for Epi-LASIK, has received FDA approval for marketing in the U.S.
GW Medical Technologies, the provider of the blood test for Alzheimer's disease known as the LymPro Test, has announced the launch of a pilot study to verify its prior results and make final preparations for FDA-applicable clinical studies.
Xilas Medical's TempTouch home infrared temperature probe has received 510(k) clearance from the FDA for the intermittent measurement and monitoring of human skin surface temperature in the home or clinic for use with people of all ages.
Venetec International, maker of the StatLock safety securement devices for catheters and other medical applications, has signed a sole-source agreement to supply Adventist Health System with catheter securement devices in intravenous (IV) start kits for peripheral IVs.
Laboratory Holdings (LabCorp) said it would acquire an Austin, Texas, medical testing company.
Cardiac Science, a manufacturer of automatic external defibrillators, announced that it has been awarded a contract from Novation, the supply company of VHA and the University HealthSystem Consortium, covering Cardiac Science's patented Powerheart Cardiac Rhythm Module -- a fully-automatic therapeutic bedside monitor-defibrillator designed for medically supervised environments such as hospitals, outpatient medical clinics and physician offices.
Bayer AG said the diagnostics division of its Bayer HealthCare unit received approval by the FDA for its hepatitis assay.
Rockwell Medical Technologies, a hemodialysis manufacturer, announced that it has signed a $2.75 million revolving credit loan facility with Standard Federal Bank, a subsidiary of ABN AMRO.
Given Imaging announced that Menorah Insurance has approved a coverage policy for its camera-in-a-pill for evaluation of the esophagus.
DOBI Medical International announced that it completed a private placement with a group of institutional and other investors for 21 million shares of its common stock at a purchase price of $0.50 per share, for expected gross proceeds of $10.5 million, and net proceeds of approximately $9.665 million.
Royal Philips Electronics and Walgreens announced that the Philips HeartStart Home Defibrillator is now available to consumers without a prescription via Walgreens.com and Walgreens.
Reliant Technologies announced that the FDA has granted 510(k) market approval of the Fraxel laser for skin resurfacing procedures, providing physicians a gentle and intelligent treatment approach to fast, remarkable results with minimal downtime and maximum safety.
Seattle Systems, a manufacturer of prosthetic, orthopedic and physical rehabilitation products, announced the release of the Seattle Power Knee and Seattle NK-1 Knee.
Confluent Surgical of Waltham, Mass., said it closed a $23 million fourth round of venture funding, money that the biosurgery firm said it will use to expand the market for its lead product.
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.