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Opinions are all over the map when it comes to whether the FDA regulates medical devices too strictly or too loosely.  Those favoring more regulation point to infamous examples like metal on metal hips and faulty defibrillator leads.  Power morcellators and duodenoscopes are the latest additions to that list.  Industry and others who favor faster access note that in Europe, many advanced devices are made available years before they are commercialized in the U.S.

The American Diabetes Association and the European Association for the Study of Diabetes have published a statement calling for the adoption of improved and harmonized safety standards for insulin pumps.  The joint statement appears in the April 2015 issue of the journal Diabetes Care.

Hospitals across the United States are deploying apps and health information technology to the Intensive Care Unit (ICU) with a goal of humanizing healthcare and improving interactions with patients and their families.

NEW DELHI:  After several horrific cases of malfunctioning medical devices, like babies being burnt to death due to short circuits in incubators or hip implants causing blood poisoning, the health ministry has approved a materio vigilance programme in an effort to ensure safety of medical devices.

In typical Apple style, CEO Tim Cook announced the debut of its open-source platform for creating mobile medical apps while standing in front of a black background at a glitzy event in San Francisco in March.  But the news contained substance too, at least from a med tech perspective.

People are hungry to participate in the first 5 iPhone-based studies enabled by Apple’s ResearchKit.  More than 19,000 participants have signed on within the first 24 hours of the mobile medical app platform’s debut.

Little did the FDA know that allowing drug makers to hand out medical-journal articles to doctors would be so controversial.  After talking about the idea for years, since 2007 at least, the Agency rolled out some guidelines last June that would govern the practice.  And now, the consumer watchdogs at Public Citizen, along with a bevy of patient groups, are in full protest mode.

The U.S. Food and Drug Administration approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent in February 2015.  This device is first to use adhesive to cut off blood supply.

The FDA has created a new category of devices – general wellness products – that the agency will exempt from regulation. The concept is a boon to makers of apps and other products that help manage weight loss, fitness, stress, sleep, and other aspects of good health.

The China Food and Drug Administration (CFDA; previously SFDA) will launch an expedited registration process on March 1, 2014 to increase availability of innovative and cutting-edge medical devices in the country.