FDAnews Device Daily Bulletin
Jan. 19, 2005 | Vol. 2 No. 13
Boston Scientific announced the launch of its Taxus Liberte paclitaxel-eluting coronary stent system in 18 countries.
A 76-year old patient underwent successful aortic heart valve replacement surgery, becoming the first person in the world to receive the 3F Enable Aortic Heart Valve, intended to eliminate the need for the cardiac surgeon to suture the device into the aortic annulus of the patient in the usual manner, saving an average of 30 minutes or more of cardiopulmonary bypass time.
Syneron Medical, a maker of medical aesthetic devices using elos (electro-optical synergy) technology, has announced that American Laser Centers (ALC) purchased $1.5 million worth of elos aesthetic devices, including the Aurora and Comet systems.
A common screening test failed to detect potentially cancerous colon growths 95 percent of the time, falsely reassuring patients and doctors, according to a new study.
NCI'S EARLY DETECTION RESEARCH NETWORK REPORTS PLATFORM AND CLINICAL REPRODUCIBILITY OF CIPHERGEN'S SELDI PROTEINCHIP
Ciphergen Biosystems announced that the National Cancer Institute's Early Detection Research Network reported completion of the first phase of its development of a proteomics platform using Ciphergen's SELDI ProteinChip System for the detection of prostate cancer.
Elekta of Sweden has said it would acquire Nasdaq-listed IMPAC Medical for $24 a share in cash, equating to an enterprise value of $190 million, a premium of 22 percent on the U.S. group's last closing price.
Abbott will begin enrolling patients during the first quarter of 2005 in its asymptomatic carotid trial, ACT I. The first trial of its kind, this multicenter, randomized trial will compare carotid artery stenting to carotid artery surgery in asymptomatic patients -- those who have not displayed symptoms of a stroke but are at-risk -- who normally would be referred for surgery.
Thermage, a maker of innovative aesthetic devices based on proprietary radiofrequency technology, characterized the countersuit filed Jan. 10 by Syneron as without merit.
MILESTONE SCIENTIFIC ANNOUNCES SECOND SUCCESSFUL EPIDURAL CLINICAL STUDY USING ITS COMPUFLO TECHNOLOGY
Milestone Scientific announced that the results of a second independent pilot clinical study have confirmed the efficacy of its CompuFlo pressure/force computer-controlled anesthetic delivery system in determining the pressure of the epidural space.
GENEOHM SCIENCES COMPLETES A $14 MILLION SECOND CLOSING OF SERIES C FINANCING FOR A TOTAL OF $26 MILLION
GeneOhm Sciences has successfully raised $14 million in a second closing of its Series C financing, bringing the total Series C to $26 million.
MANTHAMED HAS BEEN GRANTED CANADIAN DISTRIBUTION RIGHTS FOR THE BpTRU BLOOD PRESSURE MONITOR FROM VSM MEDTECH
ManthaMed, a Canadian distributor devoted to the promotion of diagnostic testing designed to detect and monitor certain medical conditions, has added another medical device to its product line.
Unilens Vision has announced the launch of a new soft, multifocal toric contact lens that will provide astigmatic patients, who now have presbyopia, with all-day comfort, ease of fit and optimum visual acuity at every distance.
ACCELERATION THERAPEUTICS' AT-101 DEVICE PROVIDES BENEFICIAL EFFECT OF VASODILATATION IN PUBLISHED STUDY
Acceleration Therapeutics has announced that a published study using its AT-101 passive exercise device showed, for the first time, that the AT-101 produces an important benefit that also occurs with active exercise.
Eyeonics, the developer of the crystalens, the first and only FDA-approved accommodating intraocular lens, has announced that more than 13,000 crystalens were implanted in the U.S. during the company's first year in the U.S. market.
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