Category: Samsung Electronics Co. Ltd.
Here's a look at some of the top regulatory stories for medical device companies this week.
South Korean healthcare regulators rule that Samsung's new Galaxy S5 smartphone is not a medical device, despite having a built-in heart-rate sensor.
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.
Samsung's new Galaxy S5 smartphone features a heart rate sensor, and South Korean regulators are reviewing the technology to determine whether it qualifies as as medical device.
MASSDEVICE ON CALL — South Korean healthcare regulators are taking a closer look at Samsung's (LON:BC94) new Galaxy S5 smartphone in order to determine whether the built-in heart rate sensor turns the phone into a medical device.
Carestream Health lands 510(k) clearance from the FDA for its Vue Motion X-ray app for mobile devices made by tech giants Apple and Samsung.
Carestream Health said it landed 510(k) clearance from the FDA for its new Vue Motion mobile app for Apple and Samsung mobile device platforms.
The app gives physicians mobile access to X-ray exams using Apple's iPhone 4 and iPad 2 devices, as well as the Galaxy Note and Galaxy S III devices made by Samsung.
Samsung plans this April to launch a new model of its Gear smartwatch featuring a heart rate sensor, even as rival smartphone maker Apple refuses to acknowledge rumors of its mHealth pursuits.
MASSDEVICE ON CALL — Technology giant Samsung (LON:BC94) announced new healthcare features for upcoming models of its Gear smartphone-connected watches, which will include heart rate sensors and the company's FDA-cleared S Health app.
Samsung wins clearance for its S Health health monitoring app for smartphones.
Samsung Electronics (LON:BC94) said it landed 510(k) clearance from the FDA for its S Health app.
The S Health app pulls biometric variables from 3rd-party devices, including calories burned, projected heart rate, blood glucose, blood pressure and sleep efficiency.