Medical Tidbits,Medtronic Receives Expanded Indication From FDA for Pillcam(TM) Colon 2 Capsule

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Medtronic plc (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) cleared PillCam(TM) COLON 2 capsule for an expanded indication for use. The PillCam(TM) COLON 2 capsule is the only non-invasive diagnostic test that directly visualizes the colon for the evaluation of polyps in patients who are at major risks for colonoscopy or moderate sedation. The PillCam(TM) capsule- a vitamin-sized capsule endoscope that is taken orally – does not require sedation, anesthesia or radiation, which makes it a more convenient procedure than other invasive colon exams.    read more

First Patients Enrolled in Medtronic Trial in Low-Risk Aortic Stenosis Patients

Medtronic plc (NYSE: MDT) today announced that the first patients were enrolled in the expanded indication trial for the CoreValve® Evolut® R System, the first and only next-generation recapturable, self-expanding transcatheter aortic valve replacement (TAVR) system commercially available in the United States. read more

New 2016 ACC/AHA Guideline Focused Update States that it is Reasonable to Choose Effient® (prasugrel) Over Clopidogrel for Certain ACS-PCI Patients with ST-Elevation Myocardial Infarction and NSTE-ACS

PRNewswire/ — A new guideline focused update provided oral antiplatelet therapy Effient® (prasugrel) with a Class IIa recommendation, meaning that it is reasonable to choose Effient over clopidogrel for the maintenance therapy of patients with acute coronary syndrome (ACS) who experience an ST-elevation myocardial infarction (STEMI) – the most severe form of a heart attack1 – or non-ST-segment elevation (NSTE) who are treated with dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI).  This recommendation applies to patients who are not at a high risk for bleeding complications and do not have a prior history of stroke or transient ischemic attack (TIA). read more

AIDS, TB Advocates to Press World Bank on Use of Middle-Income Country Designations

KIEV, Ukraine–(BUSINESS WIRE)–AHF Ukraine, the Ukrainian Center for Infectious Diseases, members of civil society and patient advocates will convene a press conference in Kiev titled “Life of Ukrainian patients is in the hands of the World Bank”at the Interfax-Ukraine news agency on April 1 at 12:30 p.m. in room 5a. (Interfax-Ukraine is located at 8 Reitarska St., room 5a; subway station Zoloti Vorota.) read more

Takeda and Teva Establish “Teva Takeda Yakuhin Ltd.” in Japan

JERUSALEM & OSAKA, Japan–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Takeda Pharmaceutical Company Limited (TSE:4502) announce the establishment of Teva Takeda Yakuhin Ltd. (“Teva Takeda Yakuhin”). The newly established business venture is pleased to announce that Mr. Hiroshi Matsumori has been appointed Chief Executive Officer and President of Teva Pharma Japan Inc. (“Teva Pharma”). Mr. Matsumori has over 34 years of rich and diverse experience in the pharmaceutical industry including in the generics and LLP businesses, the core business of the newly established business venture. Mr. Matsumori will assume this position on April 25, 2016, and will be based in Nagoya.

BTG Announces US Launch of LC Bead LUMI™, Ground-Breaking Radiopaque Embolic Bead

BTG plc (LSE: BTG), a global specialist healthcare company, today announced the launch of LC Bead LUMI™ in the US, the first commercially available radiopaque embolic bead for the embolization of hypervascular tumors and arteriovenous malformations (AVMs). LC Bead LUMI™ is a next generation development of LC Bead®, the market leading embolic bead. read more

Taiho’s TAS-102 Meets Primary Endpoint of Improving Overall Survival in Phase III TERRA Study in Asian Patients with Refractory Metastatic Colorectal Cancer

TOKYO, April 1, 2016 /PRNewswire/ ­­ Taiho Pharmaceutical Co., Ltd. of Tokyo announced on April 1 results from its Phase III TERRA study on its oral combination anticancer drug TAS­102 (product name in Japan and the US LONSURF (R), nonproprietary names: trifluridine (FTD) and tipiracil (TPI)) in Asian (China, South Korea and Thailand) patients with refractory metastatic colorectal cancer (mCRC). The TERRA study met its primary endpoint of demonstrating improvement in overall survival (OS) in patients with refractory mCRC whose disease had progressed after approved standard therapies. In this study, TAS­102 appeared to be generally well tolerated and its toxicities were consistent with what was previously reported. More detailed results from this study will be presented at a future international academic conference. read more

April 1, 2016 /PRNewswire/ — Taiho Pharmaceutical Co., Ltd. of Tokyo announced on April 1 results from its Phase III TERRA study on its oral combination anticancer drug TAS-102 (product name in Japan and the US LONSURF (R), nonproprietary names: trifluridine (FTD) and tipiracil (TPI)) in Asian (China, South Korea andThailand) patients with refractory metastatic colorectal cancer (mCRC). The TERRA study met its primary endpoint of demonstrating improvement in overall survival (OS) in patients with refractory mCRC whose disease had progressed after approved standard therapies. In this study, TAS-102 appeared to be generally well tolerated and its toxicities were consistent with what was previously reported.

New Clinical Study Reports Relationship Between Masimo’s Oxygen Reserve Index (ORI™) and Arterial Partial Pressure of Oxygen During Surgery

NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) announced today that a new retrospective study reports the relationship between Masimo’s Oxygen Reserve Index (ORI™) and arterial partial pressure of oxygen (PaO2) during surgery. The study suggests that ORI may provide an advanced indication of impending desaturation in adults undergoing surgery based on trends in the relationship between ORI and PaO2.1  read more

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