FDA Approves Apple Watch AFib as First Digital Health Tool for Clinical Trial Evaluation

News | Published: Tuesday, May 21, 2024

---

The U.S. Food and Drug Administration (FDA) has qualified the Apple Watch atrial fibrillation (AFib) history feature as the first digital health technology tool for its Medical Device Development Tools (MDDT) program. Through this program, the Apple Watch AFib history feature can be used as a noninvasive method to collect data for device evaluation in clinical trials on a case-by-case basis.^1,2

The Apple Watch AFib history feature falls under the MDDT program's category of biomarker tests and will collect data to be used as secondary endpoints to assess AFib burden in studies of cardiac ablation devices.^1,3 The device detects blood flow at the wrist and scans intervals between heart beats to deliver an AFib burden reading.³

Although the FDA has expressed concerns about patient compliance with wearables, the technology is also familiar and comfortable to many patients.³ The agency recognizes the potential for the technology to support medical device developers “by eliminating the need to provide a rationale for its collection methods and cadence ... with respect to AFib burden estimates."³

Ongoing concerns about the feature include a lack of a definition for clinically significant reduction in AFib burden and timestamps and potentially reduced performance for patients who have already undergone ablation.³ Despite these concerns, the MDDT program qualification process ensures the validity of data and supporting evidence for the tool and its promise for use in clinical trials.²

References:

1. Apple Watch AFib Feature Becomes First-Ever Digital Tool Approved by FDA to Evaluate Medical Devices. Cardiovascularbusiness.com. Published May 2, 2024. Accessed May 21, 2024. https://cardiovascularbusiness.com/topics/clinical/heart-rhythm/apple-watch-afib-feature-becomes-first-ever-digital-tool-approved-fda-evaluate-medical-devices.
2. >Phelan D. Apple Watch Heart Health Feature Wins First of its Kind Approval. Forbes.com. Published May 3, 2024. Accessed May 21, 2024. https://www.forbes.com/sites/davidphelan/2024/05/03/apple-watch-key-health-feature-wins-1st-of-a-kind-approval/.
3. Taylor NP. FDA Qualifies Apple Watch AFib Feature for Use in Clinical Trials. Medtechdive.com. Published May 6, 2024. Accessed May 21, 2024. https://www.medtechdive.com/news/fda-apple-watch-atrial-fibrillation-medical-device-development-tool/715210/.

« Back