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

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 3, which have already received FDA clearances for their respective...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Cardiology

TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Digital Health And AI Tools Advance Cardiac Event Prediction, SCAI 2025 Data Show

 
• By 

Out-of-hospital cardiac arrest remains one of the most challenging and resource-intensive emergencies in cardiovascular care. At SCAI 2025, clinicians presented a novel algorithm that improved triage decisions and reduced unnecessary interventions.

Thousands Of Cardiac Digital Twins Reveal Novel Connections With Mental Health

 

King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.

Abbott’s FreeStyle Libre CGM Reduces Cardiovascular Disease-Related Hospitalization

 

The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.

More from Device Area

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By 

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.