Four organizations have announced they are forming a new, multi-stakeholder collaboration, Xcertia, dedicated to improving the quality, safety and effectiveness of mobile health applications. The initial supporters of the collaboration include the American Heart Association (AHA), the American Medical Association (AMA), DHX Group and the Healthcare Information and Management Systems Society (HIMSS).

Acist Medical Systems Inc. announced that enrollment is complete for its Fractional Flow Reserve (FFR) Study – Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve measurement. The study, which began in November 2015, included 240 patients at 12 sites across the United States. Final results are expected to be released in mid-2017.

Experts at Johns Hopkins and New York's Mount Sinai Health System have published a suggested new plan for a five-stage system of classifying the risk of heart attack in those with heart disease. The team said the plan puts much-needed and long-absent focus on the risks faced by millions of Americans who pass so-called stress tests or have less obvious or earlier-stage danger signs.

GE Healthcare unveiled its new generation of pocket-sized, dual-probe ultrasound, the Vscan Extend. From the hospital and ambulance to more rural environments, Vscan Extend uses high image quality and wireless connectivity to help users increase clinical confidence and improve patient care.

International healthcare-focused merger and acquisition (M+A) advisory firm Vertess recently shared its vision of how a new healthcare plan from President-elect Donald Trump could impact the healthcare industry.

EXCEL Trial, TCT 2016, drug-eluting stents, CABG, surgery left main heart disease, LMCAD

The biggest news from the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting this past fall was the results of the EXCEL (Evaluation of Xience versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) Trial, which compared the latest generation Xience V drug-eluting stents (DES) to coronary artery bypass surgery (CABG).[1] The result of the 1,905-patient study was that both revascularization strategies have comparable outcomes using the latest techniques and technology in patients with a blockage in the left main coronary artery.

January 12, 2017 — Bayer Healthcare has initiated a recall of all its Medrad Intego PET Infusion System Source Administration Sets used in nuclear imaging. The company said particulates can form inside the vials. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. The FDA said use of these devices may cause serious injuries or death.

The company is recalling all product distributed between Oct. 9, 2008 to Oct. 11, 2016. This includes 86,172 products in the U.S. 

According to a recent study by the Harvey L. Neiman Health Policy Institute, the last two decades have seen a substantial decline in new enteral access procedures in the Medicare population. The study, published online in November in the Journal of Vascular and Interventional Radiology (JVIR), also found that maintenance services have increased, with radiologists and emergency physicians surpassing gastroenterologists and surgeons as the leading providers of those procedures.

January 11, 2017 — Lombard Medical Inc. recently announced approval from the Japanese Ministry of Health, Labour and Welfare for its IntelliFlex Low Profile (LP) Delivery System for the Aorfix Endovascular Stent Graft. Commercial launch will follow reimbursement approval, which is anticipated in February 2017.

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