Devices

Google Fitbit Algorithm Cleared for AFib

FDA has cleared a Google 510(k) for its Fitbit and the company’s new PPG (photoplethysmography) algorithm to identify atrial fibrillation (AFib). The algorithm is intended to power a new Irregular Heart Rhythm Notifications feature on Fitbit, Google says in a blog post.

Often, AFib is difficult to detect because there may be no symptoms and episodes can come and go. “Our new PPG AFib algorithm can passively assess your heart rhythm in the background while you’re still or asleep,” the company says. “If there’s anything that might be suggestive of AFib, you’ll be notified through our Irregular Heart Rhythm Notifications feature — allowing you to talk with your healthcare provider or seek further assessment to help prevent a significant medical event, such as stroke.”

The device is intended to detect blood volume changes through its optical heart-rate sensor on the wrist. “These measurements determine your heart rhythm, which the detection algorithm then analyzes for irregularities and potential signs of atrial fibrillation,” Google says.

Clearance was based on clinical validation data from the Fitbit Heart Study, which launched in 2020 and enrolled 455,699 participants over five months. “Data presented at the 2021 American Heart Association Scientific Sessions found that the Fitbit PPG detections correctly identified AFib episodes 98% of the time, as confirmed by ECG patch monitors,” the company says.

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