Switzerland flag

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 graphic

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

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

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 Medical Infinity DBS system

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 smart watch

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 make the rules clear for health IT innovators

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

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.