Switzerland to accept medical devices certified by the FDA
The Swiss parliament made an urgent and necessary decision paving the way for accepting medical devices certified by the FDA.
FDA’s digital health pre-certification pilot program is now open for applications
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.
Senseonics’ Eversense CGM System receives CE Mark approval
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.
Gauss Surgical’s receives CE mark for its surgical blood loss system
The company's flagship offering Triton scans surgical sponges and blood bearing canisters to estimate the amount of blood contained in them.
St. Jude’s Infinity Deep Brain Stimulation System receives CE mark
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...
FTC wants Apple’s guarantees over health data use
The idea is to prevent usage of sensitive health data collected by Apple's upcoming smart watch and the HealthKit platform without owners' consent.
Microsoft’s upcoming wearable device gets the FCC certification
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.
Tech companies want Congress to make the rules clear for health IT innovators
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.
Lenovo SW-B100 smartband caught at the FCC
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.
California lawmakers ease telehealth access for residents
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.