Devices

Apple Watch Qualified for AFib Trial Monitoring

CDRH has qualified the Apple Watch’s Atrial Fibrillation (AFib) History Feature as a medical device development tool (MDDT) for use as a biomarker test to help evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies intended to evaluate the safety and effectiveness of cardiac ablation devices. The watch feature “opportunistically analyzes pulse rate data collected by the general-purpose Apple Watch photoplethysmography (PPG) sensor to identify episodes of irregular heart rhythms consistent with AFib and provides the user with a retrospective estimate of AFib burden (a measure of the amount of time spent in AFib during past Apple Watch wear),” according to a CDRH summary document.

The summary document notes that the watch’s weekly estimates of AFib burden generated by the AFib History Feature can be used for comparative analysis across arms of a clinical study. “The AFib History Feature may be used throughout the clinical study to monitor a participant’s weekly estimate of AFib burden in order to compare weekly burden estimates before and after cardiac ablation treatment,” it says. “The AFib History Feature’s utility as a secondary endpoint is not intended to replace the findings of any primary endpoints (i.e., it cannot by itself be used to evaluate the safety and effectiveness of cardiac ablation devices).”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome