Devices

Dthera Sciences Breakthrough Status for Alzheimer’s Device

FDA has granted Dthera Sciences a breakthrough device designation, for its Alzheimer’s treatment, DTHR-ALZ. If approved , the device would become the first non-pharmacological prescription treatment for Alzheimer’s symptoms. It is intended for use in mitigating the symptoms of agitation and depression associated with major neurocognitive disorder of the Alzheimer’s type.

The prescription digital therapeutic is designed to deliver Reminiscence Therapy to patients with Alzheimer’s. It uses artificial intelligence to automatically optimize the therapy based on various forms of biofeedback from a patient, the company says. According to the Alzheimer’s Association, Reminiscence Therapy is an evidence-based psychosocial intervention that has been shown in clinical trials to improve symptoms of the disorder, but its adoption has been limited because of the investment of caregiver time and resources. DTHR-ALZ was created to provide Reminiscence Therapy with more frequency, consistency and personalization while requiring minimal investment of time and resources, Dthera Sciences 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