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Medical Devices
& Related Newswire
5/16/2006 7:31:00 PM | Competition about to heat up for J&J spine disc 
=(0) A second type of artifical spinal disc, made by Synthes Inc., is set to hit the market, awaiting final FDA approval. Medicare and insurance coverage for this type of procedure is slow in coming, however, because of reports of complications from the existing Johnson & Johnson Charite disc, and uncertainty whether disc replacement is a superior treat...
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5/16/2006 4:01:00 PM | Boston Scientific stent gets added EU OK =(0) Boston Scientific's Taxus Liberte stent has received approval in Europe for the treatment of additional conditions. Originally, approval was granted for coronary artery disease; now the drug-coated stent may be used to treat in-stent restinosis (tissue overgrowth of a stent) and total arterial occlusion (total blockage). This new stent i...
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5/16/2006 4:30:00 AM | New Guidant warning issued =(0) Boston Scientific has advised doctors that it discovered a flaw in certain defibrillator models made in March 2005. The models in question are the Vitality DS, Vitality AVT, Vitality 2, Contak Renewal 3, 4, and 4 AVT. The problem lies in a defective capacitor and doctors are urged to check their patients who have this device implanted. This is...
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5/16/2006 3:23:00 AM | Firm halts contact lens solution sales =(0) Bausch & Lomb ordered a worldwide recall of their contact lens solution, ReNu with MoistureLoc. The solution has been linked with an outbreak of a fungal eye infection which can lead to corneal scarring and blindness. So far, there is no indication that other Bausch & Lomb solutions are affected. The problem seems to lie in the chemical compos...
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5/15/2006 12:51:00 PM | Medtronic outlines its initiatives on pacemaker guides =(0) Medtronic, a medical device maker, has outlined improvements it is implementing to adhere to the guidelines recently recommended by the Heart Rhythm Society: It is expanding its panels that study performance trends and quality control; it is creating a patient advisory panel to improve communication with patients; it will work to pool data fro...
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5/10/2006 11:01:00 AM | Medtronic begins study on new ICD device =(0) Medtronic has begun a clinical trial to study a new device in the treatment of mild to moderate heart failure. The device is an implantable defibrillator, but also is able to transmit data via phone lines so that doctors can more closely monitor patient heart rate, pressure, body temperature and activity. ............
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5/4/2006 2:22:00 PM | The Mason Law Firm Announces Class Action Lawsuit Against Bausch... =(0) A class action lawsuit has been filed on behalf of anyone in the United States who used Bausch & Lomb ReNu with MoistureLoc(TM) solution contact lens cleaner. The cleaner is suspected in an outbreak of serious fungal eye infections. The named plaintiff, Barbara M. Cavallaro, had an infection so severe that she has undergone corneal transp...
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4/29/2006 6:24:00 AM | FDA warns Baxter pump customers =(0) The US Food & Drug Administration reminds users of Baxter Colleague infusion pumps to use them with caution, and have backup pumps available in case of failure. The pumps monitor intravenous flow. The pumps have been discontinued and are being redesigned by Baxter. ......
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4/28/2006 12:33:00 AM | BSX listens to Heart Rhythm Society =(0) Boston Scientific Corp. says it intends to implement all the recommendations put forth by the Heart Rhythm Society. These guidelines were developed following a recall of implanted cardiac defibrillators last year, and include: using remote monitoring to keep track of devices; independent committees for assessing device performance; direct...
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4/26/2006 5:06:00 PM | Heart Device Risks Examined =(0) A doctor's group, the Heart Rhythm Society, has called for better oversight of their products and better communication between medical device makers, doctors, and government with regard to defective devices and recalls. Several recalls occurred last year, some invoving Guidant, now owned by Boston Scientific. However another study found that peopl...
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4/26/2006 3:07:00 AM | Replacing heart device has high risk =(0) If your surgically implanted heart defibrillator is recalled, such as occurred recently with Boston Scientific devices - what do you do? Statistically, it is safer to not have it replaced, according to a new study, because risks of complications from the replacement surgery far outweigh risks of defibrillator failure. The study showed an ...
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4/26/2006 12:03:00 AM | Implantable Defibrillators Can Be Erratic, Studies Find =(0) Three studies, recently published in the Journal of the American Medical Association, examine the reliability statistics for implantable cardiac defibrillators. These devices are meant to detect an irregular heartbeat and deliver an electric shock to restore normal rhythm. Compared to pacemakers, which speed up the heartbeat with lower p...
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4/21/2006 8:20:00 AM | Abbott Completes Acquisition of Guidant Vascular Business =(0) As part of the terms of Boston Scientific's acquisition of Guidant, Abbott has acquired Guidant's vascular device business unit. One of the devices that both Abbott and Guidant have developed is the stent, a piece of wire mesh that is inserted into an artery in order to keep it open and filter out blood clots. Newer stent versions contain...
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4/18/2006 2:17:00 PM | Boston Scientific net down as heart device sales slow =(0) Boston Scientific reported slower sales of its drug-coated stent this past quarter, due to decreased demand and competition from the other maker of this type of device, Johnson & Johnson. The FDA has communicated some quality concerns to the company, but they say they are on track for the release of a new version of the Taxus Stent later this ...
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4/17/2006 1:51:00 PM | Kyphon responds to Medtronic lawsuit =(0) Medtronic, a medical device maker, is suing Kyphon Inc. for infringing on various patents relating to blood vessel catheters and spinal discs. It is also asking a judge to rule that it has not infringed upon several Kyphon patents. Rhetoric by the lawyers continues..........
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4/14/2006 6:18:00 AM | OC doctors disagree on value of artificial spinal disc implant =(0) The Charite spinal disc is the first artifical disc approved to replace damaged spinal discs. Its use is controversial, and Medicare is considering no longer paying for the procedure to insert it. A lawsuit filed in Massachusetts against DePuy, part of Johnson & Johnson, alleges that the disc caused the litigant severe back and leg pain.&...
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4/10/2006 8:15:00 PM | Guidant Trial on Recalled Heart Devices Will Be Postponed =(0) First the recall, now the lawsuits: the first lawsuit against Guidant to go to trial will begin in July, according to the Texas judge presiding over the case. The charges are fraud and deceptive trade pracices. Plaintiffs contend that Guidant knew that its defibrillators, implanted in the plaintiffs' chests, might be defective, but did not war...
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4/5/2006 2:01:00 AM | Roche's US unit Disetronic recalls ACCU-CHEK insulin delivery sets =(0) Disetronic Medical Systems Inc., a subsidiary of Roche Holding AG, has recalled the insulin infusion set, the Accu-Chek Ultraflex Infusion Set because of a potential defect that can cause hyperglycemia in patients. There is a small defect in the insulin delivery system that may cause a leak which can create an inadequate and irregular supply of ins...
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4/4/2006 7:09:00 PM | Screening, technology helping babies with hearing loss =(0) New technology and earlier screening are helping babies and young children with profound hearing loss to develop language skills. Cochlear implants in particular are being used in children as young as 1 year old to bring sound waves to the brain and to help children develop critical connections related to sound and language. Although cochlear impla...
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4/3/2006 4:09:00 PM | Guidant trial delayed over jurisdiction =(0) The first Guidant defibrillator trial is on hold because of jurisdictional questions raised by Guidant attorneys. The case was brought in Texas state court and filed by two Texas residents who also named a Texas company in the suit, but since the FDA approval has been brought into the case, Guidant attorneys are pushing to have the case moved to Fe...
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