PLUS Orthopedics USA, Inc. Announces FDA Clearance and Market Availability of Next-Generation Computer-Assisted Orthopedic Surgery System
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2007 AAOS Annual Meeting booth # 1642 -- PLUS Orthopedics USA, Inc. today announced U.S. Food and Drug Administration 510(k) clearance and market availability for the next-generation PiGalileo(TM) computer-assisted surgery system.
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The Food and Drug Administration yesterday approved for use the first totally implantable artificial heart under a program that will make the complicated, $250,000 device available for as many as 4,000 people.
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The Food and Drug Administration has for the first time approved the use of electrical stimulation of bone growth - a decades-old technology - to improve the success rate of spinal fusion
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Merck &amp; Co. said the US Food and Drug Administration has requested additional safety and efficacy information on its Vioxx successor, Arcoxia, before it considers granting US approval for the drug.
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Research and Markets (http://www.researchandmarkets.com/reports/c49927)  announces the addition of Frost & Sullivan's  new report Advances in Biomaterials for Medical Device Applications to  their offering.
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U.S. regulators have approved a new  medical device to evaluate patients suspected of having blood  clots blocking vessels, including pulmonary arteries, the  manufacturer, Biosite Inc., said on Thursday.
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Syneron Medical Ltd. (Nasdaq: ELOS), and its North American subsidiary Syneron Inc., today announced that the US Food and Drug Administration (FDA) has granted 510K marketing clearance to two of Syneron&#39;s
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THURSDAY, June 21 (HealthDay News) -- A programmable device that allows professional caregivers to monitor how patients dispense their medications has been approved by the U.S. Food and Drug Administration, the agency said Thursday.
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Shares of Applied Digital Solutions Inc. and Digital Angel Corp. soared Wednesday morning on news the companies&#39; VeriChip implantable radio frequency identification microchip for humans has been cleared by
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Boston Scientific Corp. (BSX.N: Quote, Profile, Research) said on Wednesday it received US regulatory approval for a device to treat complications that arise in patients with end-stage kidney disease who need dialysis.
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The implantable device won U.S. approval Monday for use as a temporary measure to keep alive patients on the verge of death while they wait for transplants.
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Stryker Corp , which this week said it was recalling some of its artificial hip products, on Wednesday reported higher fourth-quarter profit on increased sales of its orthopedic implants and surgical equipment.
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The U.S. Food and Drug  Administration on Thursday granted special approval for a metal  rod to treat children with chest and spine deformities from a  rare syndrome that limits lung growth and causes serious  breathing problems.
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The orthopedic device maker on Thursday accepted a takeover bid of $11.4 billion from a private equity consortium.
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Johnson & Johnson will be allowed to market an artificial spinal disk in the U.S. as a new form of treatment for people with severe lower back pain.
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THE REGION Haemonetics Corp.'s CardioPat autotransfusion system has received marketing clearance from the Food and Drug Administration. The blood recovery systems maker said it will begin customer acceptance trials in the United States immediately, and expects full market release this year. CardioPat allows surgeons to recover blood lost during and after surgery, and to make the blood available for transfusion ...
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The Food and Drug Administration yesterday permitted a unit of Johnson &amp; Johnson to market an artificial spinal disk in the United States as a new form of treatment for people with severe lower back pain.