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Fitbit Receives FDA Clearance, CE Mark For ECG App To Rival Apple

 
• By Marion Webb

Fitbit will launch its new Fitbit Sense smartwatch with ECG app in Europe, US, Hong Kong and India in October. 

Data synchronization of health book between smartwatch and smartphone in male hands

Fitbit, Inc. announced on 14 September it received clearance from the US Food and Drug Administration and the CE mark in Europe for its electrocardiogram app to assess the user’s heart rhythm for atrial fibrillation (AFib) with a planned product launch in October.

The Fitbit Sense smartwatch will rival Apple Inc.'s Apple Watch and Samsung Electronics America Inc.'s Samsung Galaxy Watch...

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Fallouh Healthcare Receives Grant Funding From Innovate UK

 
• By Natasha Barrow

Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.

Newborn Screening Tests Among FDA Classifications

 
• By Elizabeth Orr

The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.