Devices

Army Scientific Group’s Hemorrhage AI Detector Cleared

FDA has cleared a U.S. Army Biotechnology High Performance Computing Software Applications Institute 510(k) for an artificial intelligence-powered smartphone application (APPRAISE-HRI) that uses vital-sign data from trauma patients to assess their risk of hemorrhage. The clearance will permit the Army’s Medical Research and Development Command to license the device for use in military applications to help treat combat casualties who are at risk of massive blood loss.

The Android app works by collecting heart rate and blood pressure data received via Bluetooth from a patient’s external vital-sign monitor and analyzes the pattern in these data to estimate the patient’s potential risk of uncontrolled bleeding. The primary cause of death among combat casualties is uncontrolled bleeding, and the “APPRAISE-HRI application can stratify the risk of hemorrhage within 10 minutes, greatly assisting medics in triaging casualties in prolonged field care scenarios with limited resources in time to improve their chances of survival,” according to the Army.

The Army’s Medical Technology Transfer Office is currently seeking commercial partners interested in licensing the technology for use in products that can be employed by military healthcare providers in the field. The Department of Defense holds three U.S. patents related to APPRAISE-HRI.

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