That excruciating moment when patients learn their lives are potentially at risk to a “wide neck” brain aneurysm could be softened by results of a long-awaited international study led by researchers at Massachusetts General Hospital (MGH) and Harvard Medical School. According to lead author Adam Dmytriw, wide-neck aneurysms will respond better to the Woven Endobridge Web device than metal stents and blood thinners.

Space travel has known effects on human health and biology. Some, such as loss of bone density, are well understood, while others, like inflammation, are not. Now, organ-on-a-chip maker Emulate Inc. is conducting experiments on the International Space Station U.S. National Laboratory (ISS-NL) aimed at revealing clues to how the brain functions in microgravity.

Jelikalite Corp. has received a breakthrough device designation from the FDA for its wearable neurostimulation device Cognilum. The home-based system aims to reduce symptoms of moderate to severe autism spectrum disorder in pediatric patients aged 2 to 6 years. The designation was based on the results of a double-blind, placebo controlled clinical trial of 30 pediatric patients with moderate to severe autism, which showed the technology can significantly improve symptoms.

Synchron Inc. closed out 2021 by providing an opening for a patient with amyotrophic lateral sclerosis (ALS) to send the first thought transferred to a tweet via an implantable brain computer interface. Philip O’Keefe, who received one of the company’s Stentrode implants in April 2020, took over the Twitter account of Sychron CEO Thomas Oxley to say, “Hello, World. Short tweet. Monumental progress.”

PARIS – Two months after successfully listing on Euronext Brussels and Euronext Amsterdam stock exchanges, raising nearly $100 million, Onward Medical NV reported completion of enrollment in its Up-LIFT study on its noninvasive electrical spinal cord stimulation, called Arc therapy.

Movendo Technology srl and Maragal Medical PC have collaborated to provide free community screening for the risk of falls for Massachusetts Medicare patients using Movendo’s Hunova robotic technology. Hunova performs a progressive assessment on seated and standing patients to evaluate their flexibility, strength and balance. The system also provides personalized rehabilitative therapy recommendations.

Investor appetite for digital mental health technologies is expected to continue in 2022, although startups will face the challenge of standing out from competition. Venture capital firm Rock Health reported funding for digital mental health startups was the top-funded therapeutic focus in 2021, with $3.1 billion raised by the end of Q3. Key trends are emerging, as investors seek companies addressing complex mental health conditions.

2021 may mark the beginning of a new phase in treatment of depression. While genetic matching of depression therapies to patients has been touted for a decade, meta-analyses have not supported claims of improved response rates with studies often finding that any improvements seen likely came from switching patients to guideline-recommended therapies rather than any insight from genetics.

The FDA granted 510(k) clearance to Neuronetics Inc.’s MT Cap technology for the company’s transcranial magnetic stimulation system, Neurostar Advanced Therapy for Mental Health. The MT Cap speeds the process used to determine the dose and motor threshold for treatment with the Neurostar system for major depressive disorder (MDD). The company expects to begin a limited introduction of the product within weeks, with national rollout to follow in the first quarter of 2022.

Brainsgate Ltd. came up short in a recent FDA advisory hearing for the company’s Ischemic Stroke System (ISS) to treat stroke despite that the panel was unanimously satisfied with the pivotal trial’s safety numbers. One of the issues with the pivotal study was the small enrollment of study subjects in the U.S., which demonstrates once again the hazards of relying on outside-U.S. study data in applications with the FDA.