Medtech approvals: FDA releases October 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015: Summary of PMA Originals &Supplements Approved Originals: 9 Supplements: 133 Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 597 Total Active: 433 Total On Hold: 164 Summary of All PMA Submissions Originals: 7 Supplements: 74 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 133 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 161.5 FDA Time: 97.9 Days MFR Time: 63.6 Days PMA Original Approvals APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, &ZIP DEVICE DESCRIPTION / INDICATIONS P150003 10/2/15 SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation Maple Grove, MN 55311 Approval for the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System. This device is indicated for improving luminal diameter in patients with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter in lesions ≤34 mm in length. P150013 10/2/15 PD-L1 IHC 22C3 pharmDx Dako North America, Inc. Carpinteria, CA 93013 Approval for the PD-L1 IHC 22C3 pharmDx. This device is...
One month after stepping down as head of research and development at Gilead Sciences, Norbert Bischofberger has taken the helm of a new cancer drug startup in Cambridge. Kronos Bio formally announced its launch on Wednesday. The company is operating out of LabCentral, and has collected $18 million in seed financing from various venture funds and individual investors. They include Bischofberger, who spent more than 30 years with California-based Gilead (Nasdaq: GIL D) before leaving in April. Kronos’…
Ed Gregg from the CDC joins The Lancet to discuss new research into changing trends of diabetes-related mortality in the United States.
Norbert Bischofberger rides again. The 62-year-old former chief scientific officer at Gilead Sciences Inc. (NASDAQ: GILD), who stepped down last month after overseeing the development of groundbreaking and sometimes-controversial HIV and hepatitis C drugs, will become president and CEO of Cambridge, Mass., cancer-fighting startup K ronos Bio Inc. And Bischofberger, an investor in Kronos' $18 million seed round disclosed Wednesday, isn't alone: Also investing in the company is Gilead's executive…
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Yan-Yan Li, Xin-Zheng Lu, Hui Wang, Xin-Xing Yang, Hong-Yu Geng, Ge Gong, Yi-Yang Zhan, Hyun Jun Kim, Zhi-Jian Yang
Data presented at the European Congress on Obesity warns that one in eight people will have type-2 diabetes by 2045, if obesity rates continue to rise at the current rate.Guardian
A boy named Logan in Connecticut is raising diabetes awareness as he embraces a dream of racecars and someday becoming a Hot Wheels car designer.
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