FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared a Nanowear 510(k) for its SimplECG, a remote cardiac monitoring undergarment. The device collects continuous multi-channel ECG, heart rate and respiratory rate data from the garment and transfers it to a Web-based portal for review by a physician through a mobile application.

FDA has cleared a BrightWater Medical 510(k) for the ConvertX Nephroureteral Stent System for treating ureteral obstructions, which prevent urine in the kidneys from draining to the bladder. The device is implanted once and converts from a catheter to a stent in an office procedure without the need for radiation or sedation, in less than one minute, the company says. It then remains implanted in the patient like a standard internal ureteral stent.

FDA has cleared a Toshiba Medical 510(k) for the Forward Projected Model-based Iterative Reconstruction Solution (FIRST) that is intended to improve high contrast spatial resolution while reducing radiation dose up to 85% as compared to filtered back projection computed tomography imaging. “FIRST can improve high-contrast spatial resolution by up to 129% (2.29 times) as compared to filtered back projection for body imaging while reducing radiation dose,” the company says.

DRUGS

FDA has approved a new indication for Eli Lilly’s Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with Type 2 diabetes mellitus and cardiovascular disease. The approval is based on a postmarketing study required by the agency when it approved Jardiance in 2014 as an adjunct to diet and exercise to improve glycemic control.

FDA has approved a Lupin Ltd. ANDA for armodafinil tablets 50 mg, 150 mg, 200 mg and 250 mg — generic versions of Cephalon’s Nuvigil, indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy or shift work disorder. Brand sales are over $500 million annually.

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