The Apple Watch has recently been recognized by the Food and Drug Administration (FDA) with a qualification that positions the smartwatch as a valuable resource for medical device companies demonstrating the effectiveness of prevalent heart treatments.
Just last week, the Apple Watch's Atrial Fibrillation History feature was officially qualified under the FDA's Medical Device Development Tools (MDDT) program. Introduced in 2022, this feature provides estimates of a user's A-fib burden—the amount of time their heart remains in atrial fibrillation. Atrial fibrillation is a condition characterized by an irregular heartbeat that can lead to symptoms like shortness of breath and fatigue, and it increases the risk of stroke.
This FDA qualification indicates that the feature can now be used as a secondary endpoint in clinical trials, eliminating the need for additional validation. Specifically, the Apple Watch is approved to serve as a secondary endpoint in studies evaluating cardiac ablation devices. These devices aim to alleviate A-fib by using extreme heat or cold to create scars in the heart tissue that disrupt faulty electrical signals. The latest advancement in this technology, pulsed field ablation, utilizes controlled electric fields to create these scars, offering a safer alternative to traditional thermal energy methods.
Sign up for our newsletter
We like to keep our readers up to date on complex regulatory issues, the latest industry trends and updated guidelines to help you to solve a problem or make an informed decision.
Analyzing the Similarities and Differences Between ICH-GCP and GDPR in Clinical Trials
ICH-GCP and GDPR are vital for clinical trials, setting standards for participant protection and data integrity, with distinct focuses and enforcement approaches.
Comprehensive Cyber Insurance for the Life Sciences Industry
Cyber insurance provides coverage to businesses, including those in the life sciences industry, to protect against losses from cyberattacks, such as data breaches, ransomware, and other threats. For life sciences companies, which handle high-value intellectual property and sensitive data, tailored cyber insurance policies offer essential protection against financial, legal, and reputational damage while complementing existing cybersecurity measures.
UK data watchdog to fine NHS vendor Advanced for security failures prior to LockBit ransomware attack
The UK data watchdog is set to fine NHS vendor Advanced for security failures that occurred before the LockBit ransomware attack. These security lapses contributed to the vulnerability exploited during the attack.
