Medtech on the Brain

In a pilot study building on previously published Phase 2 trial results, Sinaptica’s precision therapy, combining repetitive transcranial magnetic stimulation with EEG monitoring and artificial intelligence, showed macro- and micro-structural grey matter preservation and increased functional connectivity in Alzheimer’s patients versus a sham treatment arm.

Sonara Health founder Michael Giles talks take-home methadone treatments, remote patient monitoring and sponsoring legislation to fund opioid treatment programs.

Vijay Ravindran, founder of autism therapy digital therapeutic firm Floreo, spoke to Medtech Insight about working with the FDA, and why the TAP pilot made sense for them.

Leading digital therapeutic maker’s CEO David Benshoof Klein and CMO Shaheen Lakhan discuss outlook on the DTx space, priorities going forward, and what makes Click a standout player in a changing game.

The France-based, clinical-stage medtech has enrolled first patients in a pivotal trial to evaluate overall survival in glioblastoma patients using its implanted SonoCloud-9 ultrasound device combined with a chemotherapy. If successful, it will become the first technology to optimize drug delivery by opening the blood-brain barrier.

Spun out from Cedars-Sinai to VRx Health, Inc., Xaia provides “AI-enabled, conversational therapy in relaxing spatial environments such as a creek-side meadow or a sunny beach retreat,” using the Apple Vision Pro virtual reality headset. Its insights have been eye-opening, showing significant promise for on-demand therapy at a time when mental health resources are stretched.

Cedars-Sinai’s Virtual Medicine director Brennan Spiegel discusses the shortage of mental health professional resources and how Medical Extended Reality – e.g., immersing patients in a virtual world with an AI therapy avatar – is helping to address depression, pain, and a growing host of health and wellness needs in hospital and consumer settings.

US FDA neurological device office head David McMullen is watching digital health tools make mental health treatments more widely available than ever before, though the expansion comes with some risks. Medtech Insight spoke with him about the FDA’s role in this growing field.

Swiss-based start-up DeepPsy aims to streamline mental health care using EEG and ECG biomarkers to better match depression patients with treatments. Co-founder Mateo de Bardeci discusses the company’s vision as it launches its in-house medical device as a service in Switzerland.

Motif’s “pea-sized” Digitally programmable Over-brain Therapeutic (DOT) requires 20 minutes to implant and can be activated at home with a wearable to “lift the fog” for people with depression. Motif CEO Jacob Robinson believes data captured by brain-computer interfaces and continuous monitoring will eventually be able to identify key biomarkers that enable psychiatrists to head off mental health crises.

A panel of mental health experts, advocates, and patients met recently in Manhattan to discuss the promise of the Neuronetics’ NeuroStar transcranial magnetic stimulation system, which the US FDA recently cleared to treat depression in adolescents ages 15 through 21. It is the first and only treatment of its kind the regulatory agency has cleared for this patient group.