Devices

Cardiosense Wearable Cleared as Heart Function Monitor

FDA has cleared a Cardiosense 510(k) for its CardioTag device, a wearable device capable of simultaneously capturing electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals. These signals are intended to offer clinicians a more complete picture of heart function, including insights into cardiac mechanics, blood flow, and hemodynamics, according to the company.

The clearance permits CardioTag to be used for noninvasive measurement of SCG, ECG, and PPG signals, along with heart rate and pulse rate. SCG, a technique that detects subtle vibrations from heart contractions via the chest wall, is seen as a promising tool to evaluate cardiac mechanical activity the company says.

“Clinical studies conducted by Cardiosense have demonstrated that analyzing the SCG waveform alongside ECG and PPG signals can be used to accurately assess cardiac timing intervals such as left ventricular ejection time (LVET) — a measure of how efficiently the heart is pumping blood — compared to the current standard-of-care,” the company says. Cardiosense says it will begin exploring pilots with the CardioTag device paired with AI algorithms using the SCG, ECG, or PPG data from the device.

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

Read more

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