Early feasibility studies for cardiology devices were a massive problem for the FDA and industry in times gone by, a problem that was believed to drive device flight from the U.S. That problem has been largely solved, according to the FDA’s Andrew Farb, but Farb noted that neurological devices are the next target for improved early feasibility study (EFS) development in the U.S., which suggests that the path to pivotal studies for devices in this space will soon be much less cumbersome.
PERTH, Australia – Emvision Medical Devices Ltd.’s stroke helmet could potentially transform care for stroke patients by treating them at the bedside or before they even get to the hospital. The company’s portable, non-ionizing brain scanner is capable of rapidly producing quality images to help paramedics determine if a stroke is ischemic or hemorrhagic.
Woebot Labs Inc. got a bit of a pick-me-up with the FDA's decision to grant breakthrough device designation to the company's digital therapeutic for postpartum depression. The WB001 app combines cognitive behavioral therapy with interpersonal psychotherapy and an understanding of how postpartum depression affects interactions and daily life. The investigational treatment is designed as an eight-week, prescription-only intervention for women under a physician’s care.
Digital therapeutics startup Akili Interactive Inc. has secured $160 million in a combined equity and debt financing to accelerate commercialization of its Endeavorrx platform for cognitive disorders. The company won FDA clearance and the CE mark in June 2020 for its video game-based treatment, Endeavorrx ALK-T01, for children with attention deficit hyperactivity disorder (ADHD).
With the support of the NIH’s National Institute of Child Health and Human Development and the National Institute of Mental Health, researchers at Duke University’s Center for Autism and Brain Development have developed a mobile app that can quickly screen toddlers for autism spectrum disorder without the need for specialized skills.
LONDON – Wise Srl has received CE marking for its cortical strip electrode, validating the underlying flexible electronics technology and opening the door to the development of implantable devices for long-term neurostimulation.
Dariohealth Corp. agreed to acquire Psyinnovations Inc. (dba Wayforward), a behavioral health digital platform, for $30 million. The deal represents Dario's second of 2021, following the acquisition of the digital musculoskeletal company Upright Technologies Ltd. in January. The Wayforward transaction calls for $25 million at closing, with $6 million of that in cash and $19 million in shares of Dario common stock valued at $21.09 per share. In addition, Wayforward will receive another $5 million, if behavioral health revenues exceed a certain threshold in 2022.
Collectively, lysosomal storage disorders (LSDs) are caused by malfunctions in metabolic enzymes in the lysosome system. Depending on which enzyme is missing, toxic metabolites accumulate. While the LSDs are highly heterogenous – even within one disease, presentation can vary widely – neurodegeneration is a common feature in these disorders.
While the founder of Woebot Health says that the app is not intended to replace human therapists, for the majority of the world who cannot locate an available psychologist or afford one once found, Woebot aims to offer a “radically accessible” option for mental health care.
PERTH, Australia – The launch of Australia’s first medical device development and manufacturing facility in Melbourne is set to fast-track new treatments for people with conditions such as epilepsy, Parkinson’s disease, hearing loss, stroke and diabetes.