Pharmaceutical Innovations, Inc.

MASSDEVICE ON CALL — South Korean healthcare regulators are looking to make some changes to their medical device classifications after ruling that a Samsung’s (LON:BC94) new Galaxy S5 smartphone is not a medical device, according to local reports. The Galaxy S5 sparked review of the country’s regulations when it was revealed last month that the smartphone features a built-in heart-rate sensor. "Although the Galaxy S5 is technically a medical device under the current law, it will be excluded from the category after the revision," an official from the Ministry of Food & Drug Safety said. "It will take about 25 days for the amendment." The agency plans to rewrite its laws to separate medical heart-rate sensors from those intended for "leisure," according to the Yonhap News Agency. The Galaxy S5 is scheduled to hit major markets next month. Sleepers are looking for healthcare apps The $97 million sleep disorder device market is poised for an app-takeover as patients and doctors lean toward home-testing systems. Michigan university’s med school named for Stryker founder Western Michigan University named its new medical school, slated to start classes this fall, after Stryker (NYSE:SYK) founder Dr. Homer Stryker.   FDA’s unique device identifiers poised to help track increasingly globalized recalls The FDA’s unique device identifier mandate may help medical devices makers better track recalls that are ever more complex and far-reaching. FDA’s export certificate program gets a day in court New Jersey-based Pharmaceutical Innovations filed a lawsuit against the FDA over the agency’s standards for issuing export certificates, putting to test a system that some call inconsistent with other FDA policies.