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.

PERTH, Australia – The FDA gave the thumbs up to Omniscient Neurotechnology Ltd.’s Quicktome, the first brain connectomics planning software that provides neurosurgeons with a digital brain mapping platform to visualize and understand a patient's brain networks before performing brain surgery. By visualizing networks that are responsible for complex functions such as language, movement, and cognition, Quicktome assists neurosurgeons in making more informed decisions and reduces surgical uncertainty.

Fibromyalgia is an often debilitating condition, characterized by chronic pain throughout the body that can leave patients fatigued, depressed and unable to perform even the simplest of activities. While a handful of drugs have been approved to treat this autoimmune disorder, they can have unpleasant side effects and do not benefit all patients. To that end, the FDA has granted a breakthrough device designation to Neurometrix Inc.’s Quell wearable neurostimulation device for treating the symptoms of fibromyalgia in adults.

Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.

PARIS – Aleva Neurotherapeutics SA reported the first successful implantation of its Directstim directional deep brain stimulation (DBS) system into a patient suffering from Parkinson’s disease. The procedure involving this new generation of active brain device was performed by neurosurgeon Stephan Sobottka, from the Clinic for Neurosurgery at the University Hospital Carl Gustav Carus in Dresden, Germany.

Orexo AB enrolled the first patient in a pivotal trial of its digital therapeutic Modia plus sublingual buprenorphine/naloxone for treatment of opioid use disorder (OUD). Orexo’s Zubsolv, the combination of buprenorphine and naloxone used in the study, has been employed to help U.S. patients with OUD since 2013.

Pear Therapeutics Inc. released nine-month, real-world data showing long-term reduction in costly health care utilization categories, including inpatient stays and emergency department visits, in patients with opioid use disorder (OUD) who utilize its Reset-O prescription digital therapeutic. The findings suggest that Reset-O could help to stabilize patient outcomes long-term when used in conjunction with outpatient treatment.

Axogen Corp. has developed a suite of products to meet the needs of the 1 million patients in the U.S. who undergo surgery each year to repair peripheral nerve damage. While the process the company uses to decellularize nerves harvested from human donors and clear them of all cellular debris so they can be used as scaffolding for nerve regeneration has been successful, with the Recon study, Axogen aims to increase the utility of the purified nerve tissue by adding materials that promote growth.