The lag in FDA approval time for major medical innovations has come increasing concerns about the ability of the United States to remain at the forefront of research, especially in light of stringent FDA policies regarding clinical trials and device approval.

PHS Technologies Group LLC, a division of PACSHealth LLC, announced that it will integrate VirtualDose CT (computed tomography) software from Virtual Phantoms Inc. into their DoseMonitor product.

carotid artery stenting, outcomes, JACC, Beau Hawkins, Robert Yeh, CARE Registry

Hospitals performing carotid artery stenting vary considerably in rates of in-hospital stroke or death, according to a study published in JACC: Cardiovascular Interventions. Those rates can range from 0 to 18 percent overall, and from 1.2 to 4.7 percent when accounting for variation in health of patients at admission.
CardiAQ, Edwards, acquire, acquisition, Fortis, TMVI, mitral valve replacement

Edwards Lifesciences Corp. announced that it has agreed to acquire CardiAQ Valve Technologies Inc., a privately held company and developer of a transcatheter mitral valve replacement (TMVR) system.
sentraheart lariet, LAA occlusion, FDA safety alert

The U.S. Food and Drug Administration (FDA) is alerting healthcare providers and patients of reports of patient deaths and other serious adverse events associated with the use of the Lariat Suture Delivery Device used for minimally invasive surgical closure of the left atrial appendage (LAA)
21st Century Cures Act, H.R. 6, HR-6, HR 6, medical device innovation

The U.S. House of Representatives July 10 passed its version of the 21st Century Cures Act (H.R. 6), designed to improve the U.S. healthcare innovation infrastructure. It was approved in a bipartisan vote of 344-77. The bill calls for providing resources to researchers working on next-generation medical devices and therapies. The legislation is aimed at addressing concerns that U.S. healthcare innovation is lagging behind the rest of the world due to large amounts of time-consuming and expensive regulatory oversight requirements that some feel are stifling innovation and the ability of startup companies to bring new products to market.
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