Peijia Medical Ltd. has received two marketing approvals from China’s NMPA for its catheters to be used in neurointerventional surgery. They are the balloon guide catheter (BGC) Fluxcap and delivery balloon dilation catheter Fastunnel. Both were developed by Peijia’s wholly owned subsidiary Achieva Medical Ltd.

Ekso Bionics Holdings Inc. added a new indication for its robotic Eksonr exoskeleton with a U.S. FDA 510(k) clearance for use of the mobility device in patients with multiple sclerosis (MS). The green light for MS follows clearances for stroke and spinal cord rehabilitation in 2016 and acquired brain injury (ABI) in 2020.

The U.S. FDA has granted clearance for Earlitec Diagnostics Inc.’s Earlipoint evaluation tool for the diagnosis and assessment of autism spectrum disorder (ASD) in children aged 16-30 months. The eye-tracking technology utilizes Dynamic Quantification of Social-Visual Engagement (DQSVE), which captures a child’s moment-by-moment looking behavior. The clearance was based on positive results from two studies in which more than 500 children were enrolled.

Bipolar disorder (BPD) is disabling, destructive and notoriously difficult to diagnose. Research indicates that up to 40% of patients diagnosed with major depressive disorder or unipolar depression actually have BPD and treating them with antidepressants alone runs an elevated risk of worsening their condition. But the issue is not one-sided: other studies found that 30% to 60% of patients diagnosed with BPD do not meet the clinical criteria for the illness and may be taking powerful mood stabilizers needlessly while failing to receive potentially beneficial therapies.

Otsuka Pharmaceutical Co. Ltd. and Ai-Brainscience Inc. signed an exclusive sales agreement for Japan that will see Otsuka market Ai-Brainscience’s eye-tracking application to test for cognitive function. The eye-tracking app, AiBS-01, could become the first dementia diagnosis application to receive regulatory approval in Japan. Ibaraki, Japan-based Ai-Brainscience (AiBS) is developing devices that use the eye-tracking based cognitive assessment test to detect early dementia beyond the conventional assessment methods performed by specialists.

Primary care doctors in England have been told by the National Institute for Health and Care Excellence (NICE) to prescribe a digital therapeutic instead of sleeping tablets for patients suffering with insomnia. Sleepio, an app developed by London-based Big Health Ltd. that uses an algorithm to provide personalized cognitive behavioral therapy (CBT), could benefit up to 800,000 people, according to NICE. It is recommending use of the app as an effective alternative to drugs such as zolpidem and zopiclone, after weighing evidence from 28 studies, including 12 randomized controlled trials.

Beacon Biosignals Inc. has teamed up with Stratus Inc., a provider of electroencephalogram (EEG) services, to improve at-home brain monitoring and neurodiagnostics using Beacon’s machine learning-driven neuroanalytics platform. The collaboration will increase opportunities for home-based studies of Alzheimer’s and other neurological diseases.

Hypothermic therapy startup Tectraum Inc. has finished enrolling patients in a pivotal trial of its Pro2cool device for the treatment of concussion. The company expects to submit the results to the U.S. FDA to support regulatory clearance by the end of this year and commercially launch Pro2cool in the U.S. in the first quarter of 2023.

The rehabilitation robot market will soon have a new entrant as Able Human Motion SL prepares to launch a next-generation robotic exoskeleton. The Universitat Politècnica de Catalunya spin-off is on a mission to shake up the exoskeleton technology market with a low-cost, lightweight model that can be accessed by anyone with mobility impairments.

A research team led by neuroscientists and neurosurgeons from Paris-Saclay University have recently managed to demonstrate that electrical stimulation of the thalamus can restore consciousness when this has been impaired.