Devices

B-Secur HeartKey Software Library Cleared

FDA has cleared a B-Secur 510(k) for its HeartKey software library, which was developed to enable scalability of medical grade EKG/ECG across “Internet of Things” devices. The company says its suite of powerful EKG/ECG algorithms combine user identification, health and wellness to generate accurate data encrypted through a user’s unique heartbeat. The algorithms can be “quickly and easily integrated in semiconductors for a broad range of devices in the consumer wellness, health monitoring and medical technology sectors, enabling rapid integration of medical-grade EKG/ECG software with those devices,” it says. They also aid technology device manufacturers and healthcare service providers to “generate advanced medical-grade wellness and health data from any device and platform.”

B-Secur says the FDA clearance covers the following EKG/ECG feature algorithms: signal conditioning, heart rate and arrhythmia analysis. Additionally, the HeartKey Arrhythmia Analysis algorithm currently includes atrial fibrillation, bradycardia and tachycardia.

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