FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared a Butterfly Network 510(k) for what the sponsor describes as the world’s first “ultrasound-on-a-chip” based imaging system, the Butterfly iQ for the iPhone. The clearance covers 13 clinical applications, the “broadest ever for a single ultrasound transducer,” the company says. “By combining almost 10 thousand sensors, 40 times more than systems costing 100 times as much, Butterfly ushers in a new era of accessible, high-performance medical imaging.”

FDA has cleared a Nitiloop 510(k) for the Nova Cross Extreme and Nova Cross BTK, dedicated microcatheters for use in conjunction with conventional guidewires to access discrete regions of the coronary and peripheral vasculature. The low profile micro-catheters use an expandable nitinol scaffold shaped like a loop located at the distal end of the device. The loop is expanded and collapsed by the operator, providing guidewire support and positioning within the artery lumen, according to the company.

DRUGS

FDA has approved a Tesaro supplemental NDA for Varubi (rolapitant) IV in combination with other antiemetic agents in adults for preventing delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy. Delayed nausea and vomiting can occur anytime between 25 and 120 hours following chemotherapy, and is often extremely debilitating, the company says.

FDA has approved an Alexion Pharmaceuticals supplemental BLA for Soliris (eculizumab) as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive. Soliris is described as a first-in-class terminal complement inhibitor, and is approved in the U.S. for treating patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis. Approval for the expanded indication is based on data from the Phase 3 REGAIN study that “demonstrated treatment benefits for patients with anti-AchR antibody-positive gMG who had previously failed immunosuppressive treatment and continued to suffer from significant unresolved disease symptoms, which can include difficulties seeing, walking, talking, swallowing and breathing,” the company says.

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