South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital therapeutic software solution to aid depression screening and diagnosis on Dec. 20. Approved as a class II software as a medical device, Acryl-D01 utilizes a patient’s medical records to quantify and analyze the individual’s emotional response and assess the probability of having clinical depression based on the data.

Researchers from Engrail Therapeutics Inc. recently described the pharmacological characterization of ENX-105, a new class of molecule that combines 5-HT1A/2A receptor agonism with D2/3 receptor antagonism, to be used for its antianhedonic and antipsychotic effects.

Biohaven Ltd.’s BHV-7000, a selective Kv7.2/7.3 potassium channel activator, is in phase II/III development for the treatment of focal epilepsy, generalized epilepsy, bipolar disorder and major depressive disorder. The company recently presented findings from preclinical testing assessing the candidate’s potential for the treatment of comorbidities associated with epilepsy.

Beacon Biosignals Inc. can rest easy now that it has received U.S. FDA authorization of its predetermined change control plan for the Dreem 3s, a wearable sleep monitor that conducts electroencephalograms as users sleep. The authorization allows Beacon to incorporate updates to the Dreem 3S sleep-staging algorithm acquired through machine learning without submitting a new 510(k) application.

Diagnosing depression and other mental illnesses is largely subjective, but that could soon change as Sydney-based Trivarx Ltd. developed an AI-based algorithm that uses heart rate and heart rate variability coupled with sleep disturbance to diagnose major depressive episodes.

The first patenting from Neuro-Joy Ltd. details development of a device that electrically stimulates facial nerves and muscles in order to emulate a facial expression configured to ameliorate a mood disorder and improve symptoms of depression, anxiety and sleep disorders.

Targeting NMDA in mental health has chalked wins but not universally, as shown by Sage Therapeutics Inc.’s failure of the placebo-controlled phase II Lightwave study testing dalzanemdor in Alzheimer's disease, which missed the primary outcome measure, another bit of bad luck from the company that was disclosed Oct. 8.

In what represents the first patenting from Cerathrive Ltd., its co-founder and CEO, Sarah Turner, describes their development of the Cera system, which they claim to be the first and only U.S. FDA-cleared red-light device that targets the gut-brain axis to improve focus and energy levels.