Devices

Pear Therapeutics Seeks Somryst Marketing OK

Pear Therapeutics is asking FDA for marketing authorization for its Somryst, described as a prescription digital therapeutic intended for use in treating adults with chronic insomnia and depression. The company says Somryst is intended to provide neurobehavioral interventions, specifically cognitive behavioral therapy for insomnia and sleep restriction driven by algorithms to reduce the severity of insomnia and symptoms of depression.

Pear says Somryst is the first product submitted to FDA through the software pre-certification pilot program as part of the agency test plan released in January. Pear is one of nine companies participating in the FDA digital health software precertification pilot program.

The company says its submission is supported by data from two trials evaluating the effectiveness of the investigational digital therapeutic. The studies enrolled more than 1,400 adults with chronic insomnia, some 1,100 of whom also had depression. It says significant improvement was seen in patients in the treatment arm following a nine-week treatment course.

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