Latest Premarket approval Stories

2014-08-28 23:15:02

Learn how to navigate an advisory panel from an insider’s perspective. FDAnews has teamed Chris Sloan, Principal Consultant at Quintiles Consulting and former FDA device advisory panelist, and Michael Morton, Medtronic’s chief for global regulatory affairs, in a 90-minute presentation on the FDA advisory panel process. Falls Church, VA (PRWEB) August 28, 2014 FDA Device Advisory Panel Review Process: How to Ensure Successful Outcomes **FDAnews Webinar** Sept. 24, 2014 — 1:30 p.m....

2014-06-10 08:29:11

PITTSBURGH, June 10, 2014 /PRNewswire/ -- Cohera Medical, Inc.(®), a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that a meeting of the General and Plastic Surgery Devices Advisory Panel has been scheduled for August 1, 2014 to review its Premarket Approval (PMA) application for TissuGlu(®) Surgical Adhesive. The Panel, comprised of independent surgeons and...

2014-05-27 23:01:09

Medtronic is attempting to rely on the legal concept of preemption, which has been used by a number of medical device makers when arguing liability lawsuits filed over U.S. Food and Drug Administration- (FDA) approved devices. Port Washington, NY (PRWEB) May 27, 2014 A key issue in this case involves “failure-to-warn” claims that may be preempted by federal oversight of high-risk medical devices. Following the high court’s October request that it provide an opinion in a dispute...

2014-05-13 12:30:05

LONDON, May 13, 2014 /PRNewswire/ -- Reportbuyer.com has added a new market research report:Commercial Aircraft Parts Manufacturers Approval (PMA) Market Forecast 2014-2024http://www.reportbuyer.com/countries/north_america/usa/commercial_aircraft_parts_manufacturers_approval_pma_market_forecast_2014_2024.htmlReport DetailsThe commercial aircraft PMA market offers a unique range of opportunities and challenges which will assume ever greater prominence in the years to come. Companies...

2014-05-08 16:26:08

CHARLOTTE, N.C., May 8, 2014 /PRNewswire/ -- SonaCare Medical, LLC, a leader in minimally invasive high intensity focused ultrasound (HIFU) technology, today announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled a Gastroenterology and Urology Devices Advisory Committee Panel meeting on October 2, 2014 to review the Company's Premarket Approval (PMA) application for Sonablate® 450 for the treatment of recurrent prostate cancer following external beam...

2014-04-10 08:29:04

DUBLIN, April 10, 2014 /PRNewswire/ -- Research and Markets ( http://www.researchandmarkets.com/research/t45c8d/fda_approval) has announced the addition of the "FDA Approval Process for Medical Devices - Updated Programme Includes all the Current FDA Guidelines (Seminar, London)" [http://www.researchandmarkets.com/research/t45c8d/fda_approval ]conference to their offering. (Photo: http://photos.prnewswire.com/prnh/20130307/600769 ) The FDA Approval Process...

2014-01-31 08:25:48

ATLANTA, Jan. 31, 2014 /PRNewswire/ -- Acella Pharmaceuticals, LLC, a specialty pharmaceutical company, recently announced the approval and launch of Loutrex Topical Cream following a successful 510(k)(1 )notification with the Food and Drug Administration (FDA), which determined that Acella's 510(k) submission was equivalent to another legally U.S.-marketed device and at least as safe and effective as the predicate. The approved 510(k) (Loutrex) is indicated to manage and relieve...

FDA Regulatory Process Variable
2014-01-22 09:31:53

Rebekah Eliason for redOrbit.com – Your Universe Online According to a recent study, the approval of drugs by the Food and Drug Administration (FDA) is based on widely varying clinical trials between 2005 and 2012. The background from the article states that “FDA review of new drug applications is guided by the Federal Food, Drug, and Cosmetic Act, which requires 'adequate and well controlled investigations' to determine efficacy. Many patients and physicians assume that the safety...

2014-01-06 16:27:53

Requires Premarket Approval for ECP Devices for Other Intended Uses WESTBURY, N.Y., Jan. 6, 2014 /PRNewswire/ -- Vasomedical, Inc. ("Vasomedical") (OTCBB: VASO), a diversified medical technology company specializing in the design, manufacture and sale of medical devices including EECP(®) (Enhanced External Counterpulsation) Therapy systems, the gold standard of ECP therapy, announced today that the U.S. Food and Drug Administration (FDA), Department of Health and Human Services,...

Word of the Day
  • Remarkable; prodigious.
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This word is probably from the dialectal 'boldacious,' a blend of 'bold' and 'audacious.'