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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.

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More from Cardiology

HRS Released Framework For Afib Center Of Excellence To Improve Outcomes Through Multidisciplinary Care

 
• By Marion Webb

Medtech Insight sat down with Jared Bunch, chair of AF Center of Excellence Task Force, at HRS 2025 to discuss the newly HRS released framework for Afib Center of Excellence and get his perspective on the role industry could play to help clinicians improve patient outcomes.

Former FDA Head Tells Heart Society To ‘Get Involved’ To Protect Health Innovation

 
• By Elizabeth Orr

Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.

FDA Issues A Pair Of Early Alerts For Intravascular Catheters

 
• By Brian Bossetta

The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.

Looking Back Towards The Future

 
• By Brian Bossetta

As it celebrates 75 years shaping the medtech industry, Medtronic invited Medtech Insight to its Minneapolis headquarters to get a closer look at the company’s past, what it’s working on now, and what’s on the horizon.

More from Device Area

No Knife, No Burn, Just Bubbles: HistoSonics Hits 90% Tumor Control In #HOPE4Liver Trial, Eyes IPO Timing

 
• By Marion Webb

HistoSonics, which developed a noninvasive technology to destroy tumor cells, reports 90% local tumor control at 12-month follow-up in the #HOPE4Liver Trial. The Edison System, cleared by the US FDA in late 2023, is also being evaluated for kidney and pancreatic tumors. CEO Mike Blue said the medtech is financially secure but watching public markets as it considers an IPO.

Medtronic Presents Data To Boost Hugo’s Odds Of Getting FDA Nod

 
• By Brian Bossetta

Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.

Roche Diagnostics Hit By China Reforms As Q1 Sales Remain Flat

 
• By Shubham Singh

While Roche continues to view China as a strategic growth market, a sharp 23% decline in Chinese diagnostics sales offset gains in other regions and segments. Despite near-term headwinds, Roche is betting on strong instrument placement growth across its Core Lab, Molecular, and Near Patient Care segments to fuel future demand for consumables and services–key components of its long-term medtech strategy.