The Swiss parliament made an urgent and necessary decision paving the way for accepting medical devices certified by the FDA.
The focus of the Pre-Cert program is not on particular products but on firms and developers, which in turn (if pre-certified) will be able to more easily certify all of their products.
The system includes an implanted glucose sensor that lasts up to 90 days, a wearable smart transmitter to calculate glucose levels, and a mobile app.
The company's flagship offering Triton scans surgical sponges and blood bearing canisters to estimate the amount of blood contained in them.
The Bluetooth-enabled system is made for people suffering from Parkinson's, tremor and dystonia; it comes in two sizes to better match patient needs...
The idea is to prevent usage of sensitive health data collected by Apple's upcoming smart watch and the HealthKit platform without owners' consent.
The previously rumored Microsoft smart watch has been caught at the FCC while getting the necessary regulatory approval to be sold in the U.S.
58 companies sent a letter to Congress requesting that the FDA implements a risk-based framework for deciding how health IT companies should be regulated.
From what we can tell, this will be a rather basic fitness band that will be able to track one's activity (or their lack off), sleep and heart rate.
Under the new rules, all patients have to do is provide verbal or written consent to being treated through telehealth at an initial meeting with their provider.