Devices

Empatica Adds 2 Biomarkers to Monitoring Device

FDA has cleared an Empatica 510(k) for two new digital biomarkers for its Empatica Health Monitoring Platform — pulse and respiratory rate. “With the addition of pulse and respiratory rate, the Empatica Health Monitoring Platform now includes six FDA-cleared digital biomarkers for use in clinical trials,” Empatica says. The device received its initial FDA clearance 11/2022, which included monitoring for electrodermal activity, SpO2, skin temperature, and movement during sleep. “Beyond the FDA-cleared measures provided, the Empatica Health Monitoring Platform also offers access to raw data from the EmbracePlus sensors, and over 100 research-grade biomarkers,” the company says. Additionally, the platform includes Empatica’s proprietary Care software suite, secure cloud infrastructure, and clinically validated digital biomarkers.

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