UPDATE 3-Cyberonics gets FDA OK for small study
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US regulators, who rejected Cyberonics Inc.&#39;s (CYBX.O: Quote, Profile, Research) device to treat depression in August, cleared the therapy
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Medical devices maker Cyberonics Inc.  on Monday said it received a warning letter from the U.S. Food and Drug Administration saying the company's  response to issues involving manufacturing practices at its Houston operations has been insufficient.
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An unsurprising response from the FDA.
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Boston Scientific Corp. said Monday that it received Food and Drug Administration clearance to market a device designed to lower the risk of heart attacks during angioplasty and stenting procedures.
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The FDA, which has been under criticism for its lengthy approval process, this week approved two new drugs for multiple sclerosis and cancer treatment.
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The FDA's approval of Fentora comes just in time for the drug company.
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When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients' medical records almost instantly. The FDA found "reasonable assurance" the device was safe, and a sub-agency even called it one of 2005's top "innovative technologies."
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ATLANTA -- A new device that was studied in Atlanta has been approved by the US Food and Drug Administration to help stroke victims.
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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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(HealthDay News) -- Here are the latest clinical trials, courtesy of Thomson CenterWatch:
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Shares of Oragenics Inc. jumped after the biotechnology company reported Tuesday that the Food and Drug Administration allowed it to proceed with safety trials on a lifelong tooth decay protection rinse that
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EPIX initiates a safety trial and gets good efficacy data.
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The results from the new clinical trial could increase the chances that the Food and Drug Administration will approve the drug for that use.
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Genzyme Corp.'s not-yet-completed $1 billion acquisition of Ilex Oncology Inc. appeared to pay off yesterday when an advisory committee to the Food and Drug Administration recommended the agency approve Ilex's experimental cancer treatment for children with certain types of leukemia.
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The first implantable treatment to  prevent sleep apnea has received approval from U.S. regulators,  the company that developed the procedure said Tuesday.
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The U.S. Food and Drug Administration on Thursday approved a medical device maker's request to sell at-home heart defibrillators without a prescription.
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WASHINGTON -- The Food and Drug Administration has approved an implantable computer chip that can be inserted in patients to pass along their medical history to doctors.