Devices

FibriCheck Smartphone App Cleared for Heart Rhythm

FDA has cleared a FibriCheck 510(k) for its smartphone application that monitors heart rhythm disorders by using an optical signal originating from a smartphone. The app uses a smartphone camera or the optical sensors of a smartwatch to detect heartbeats and derive a heart rhythm, according to the company. The technique is based on photoplethysmography, which uses artificial intelligence in combination with medical software to perform an accurate analysis of the heart rhythm and informs users and their physician about their condition.

The device is intended to detect atrial fibrillation, Fibricheck says. To obtain clearance, FibriCheck had to demonstrate its accuracy compared to traditional technology to detect heart rhythm disorders using an electrocardiogram (ECG). “FibriCheck succeeded in achieving equal accuracy results compared to a state-of-the-art external device that connects to a smartphone with two electrodes to record a single lead ECG,” it says.

Using FibriCheck, a user places a finger on the smartphone’s camera for one minute. “The camera will then measure the light reflection caused by the blood that is flowing in the fingertip (photoplethysmography),” the company says. “Based on this, a signal is constructed which represents the pulse signal. After each measurement the user is prompted to enter his symptoms (if any) and the data is sent to an online platform where artificial intelligence ensures an accurate diagnosis of the heart rhythm.”

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