The digital therapeutics market has seen an explosion of innovative products and interested investors. Regulators, too, have acknowledged their potential to improve outcomes in patients with chronic or debilitating conditions – often at lower cost and with less side effects than traditional drug therapies. To that end, the FDA has granted breakthrough device designation to Swing Therapeutics Inc. for its prescription digital therapeutic for the management of fibromyalgia.
The FDA has given the green light to Spintech Inc. for its STAGE (strategically acquired gradient echo) magnetic resonance imaging device. The post-processing software platform allows MRI technicians to capture higher-quality brain images in significantly less time than standard approaches.
Zoll Medical Corp. has released its Remedē EL-X system for the treatment of central sleep apnea in adults, following the receipt of FDA approval. The next-generation implantable neurostimulation device will be rolled out in a phased launch in implanting centers in the U.S.
Researchers from The Hong Kong University of Science and Technology (HKUST) have developed a blood test to detect Alzheimer’s disease (AD) early. They said the test has an accuracy level of over 96% and can also monitor disease progression. This is a new approach to detecting AD compared to the commonly used cognitive tests and invasive methods that detect changes in the brain caused by AD.
Brain-wide genome editing via a single systemic dose of modified adeno-associated virus variants that cross the blood-brain barrier may represent a promising new approach for the development of disease-modifying treatments for familial Alzheimer's disease. This strategy could also be applicable to other central nervous system (CNS) disorders, according to a proof-of-concept (PoC) study led by researchers at The Hong Kong University of Science and Technology (HKUST).
Post-traumatic stress disorder (PTSD) affects about 8 million Americans a year, disrupting lives with nightmares, memory loss, feelings of isolation and other negative effects. Treatment typically involves psychotherapy, but many patients do not find relief. To that end, the FDA has granted breakthrough device designation to Evren Technologies Inc. for its noninvasive Phoenix earbud device for treating PTSD.
The FDA’s device center has a mantra of sorts when it comes to the details, or lack thereof, in guidance, which is “talk to us early and often.” For device makers eyeing the brain-computer interface (BCI) device space, this mantra has been applied to the question of pivotal study enrollment numbers, suggesting that some sponsors will find their pivotal studies come with a case of sticker shock sufficient to force them to rethink their research and developmental plans.
Researchers from Finland and Italy published a biomarker-based algorithm for the diagnosis of dementia in the journal Diagnostics. The algorithm enables clinicians to distinguish between various neurodegenerative diseases with shared clinical presentations and select appropriate treatment. The algorithm relies primarily on blood biomarker measurements to diagnose the type of dementia much earlier than is possible with the diagnostic tools in use today.
Happify Inc. launched Ensemble, a prescription digital therapy designed to treat patients with major depressive disorder (MDD) or generalized anxiety disorder (GAD). The app joins several others that target both depression and anxiety, including the eponymous apps made by Woebot Health (Woebot Labs Inc.) and Youper Inc., although it is the only one that requires a prescription in the pack.
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