explore -WSS

explore

author：knowledge 2025-09-28 21:06:30 - browse：29489

Person wearing a smart watch. -- first opinion coverage from STAT — Adobe

The Apple Watch has secured a new qualification from the Food and Drug Administration that could make the smartwatch an appealing tool for medical device companies hoping to illustrate the benefits of a common heart procedure.

Last week, the Apple Watch’s Atrial Fibrillation History feature became the first digital tool qualified under the Medical Device Development Tools (MDDT) program. Released in 2022, the feature estimates a user’s A-fib burden, or how much time they spend in atrial fibrillation, which is an irregular heart rhythm that can cause shortness of breath and fatigue, and is also linked to an increased risk of stroke.

The qualification means that FDA has determined in advance that sponsors can use the feature as a secondary endpoint in clinical trials without having to do additional work. Specifically, the Apple Watch is qualified for use as a secondary endpoint in clinical trials for cardiac ablation devices, which reduce the electrical signals that cause A-fib by scarring the heart with extreme heat or cold energy. Pulsed field ablation is the latest version of the technology, using a controlled electric field to scar tissue rather than the riskier thermal energy.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+.

Already have an account? Log in

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$30

for 3 months, then $39/month

$30 for 3 months Get Started

Then $39/month

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： 23andMe had bad news about my health. I wish a person had delivered it
Next article： CRISPR gene editing developments we’re watching in 2024

Wikipedia

WSS

In Spain, a hospital brews its own CAR

Violet CEO on training clinicians to promote more inclusive care

Three trends to watch in biotech in 2024

The United States is paying nearly triple for new Covid vaccines

SEC charges former device maker CEO with $41 million fraud

RSV injection headlines need to be accurate for good uptake

entertainment

explore

This article is exclusive to STAT+ subscribers

Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+.

Wikipedia

How one medical school became remarkably diverse

Medicare Advantage beneficiaries sue Humana over algorithm use

The Supreme Court will review a ruling striking down a domestic violence federal gun ban

Stop Congress from blocking public access to science

At least 13 dead in Texas as scorching temps continue

Christmas in the PICU brings some surprising joy

How one medical school became remarkably diverse

Why health records don't always know when patients are dead

In Memoriam: Notable people who died in 2023

SEC charges former device maker CEO with $41 million fraud

knowledge

What STAT readers think about the FDA and patient advocacy

Bristol Myers buys into radiopharmaceuticals with RayzeBio

Health insurers' Q3 question: how much care are people getting?

Nobel honors Karikó and Weissman's enduring partnership

What STAT readers think about the FDA and patient advocacy

Bristol Myers buys into radiopharmaceuticals with RayzeBio

hotspot

Wikipedia

hotspot

knowledge