05 Jan 2019

WHEN MEDICINE MAKES PATIENTS SICKER

  By Sydney Lupkin Photos by Heidi de Marco Despite the jackhammer-like rhythm of a mechanical ventilator, Alicia Moreno had dozed off in a chair by her 1-year-old’s hospital bed, when a doctor woke her with some bad news: The common stool softener her son, Anderson, was given months earlier had been

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21 Dec 2018

FDA SEEKS COMMENTS ON UPDATE RADIATION CONTROL RULES BY FEB. 19

By AuntMinnie.com The U.S. Food and Drug Administration (FDA) has issued a draft guidance for an update to its radiation control regulations covering the manufacturing of diagnostic x-ray equipment. The guidance will supersede previous rules issued in 1989. Titled “Clarification of radiation control regulations for manufacturers of diagnostic x-ray equipment,”

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16 Jul 2018

AVINGER RECEIVES FDA CLEARANCE FOR PANTHERIS DEVICE; SHARES AHEAD 47% PREMARKET

Avinger has received 510(k) clearance from the FDA for its next generation Pantheris Lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of peripheral artery disease (P.A.D.). Lumivascular is the only technology that combines real-time intravascular imaging with highly effective catheters for the treatment of P.A.D. The Company intends to launch two versions

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26 Mar 2018

SURMODICS GETS FDA OK TO SELL TELEMARK MICROCATHETHETER

  The U.S. Federal Food and Drug Administration has given Surmodics clearance to sell its Telemark .014-inch coronary and peripheral support microcatheter. The 510(k) approval allows Surmodics to start shipping a device designed for use in the treatment of peripheral lesions and complex coronary and peripheral lesions. Telemark brings together

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