Cambridge-based Sinaptica Therapeutics, a company providing electromagnetic treatment for patients with neurodegenerative diseases, announced its receipt of FDA Breakthrough Device Designation for its non-invasive SinaptiStim - AD System, designed to treat cognitive and functional decline in Alzheimer's patients.
SinaptiStim uses neurostimulation and brain wave monitoring technologies with an AI...
Calif.-based DyAnsys, a medical device company specializing in the autonomous nervous system, announced Primary Relief, its percutaneous electrical nerve stimulator (PENS) system, received approval by the FDA to treat postoperative pain following cardiac surgery.
According to DyAnsys, the PENS system can be used for up to three days following cardiac surgery and, in a clinical trial, reduced...
Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.
In fact, the FDA is turning to developers in the digital health space to help solve some of the country’s most difficult problems. In May, the agency announced an innovation challenge aimed at tackling the...
DyAnsys, a medical device company specializing in the autonomic nervous system, announced this week that it has received FDA approval for a wearable auricular neurostimulation device designed to treat symptoms of opioid withdrawal.
The device, called Drug Relief, is now available to providers in the US, and is distributed in the EU by the DyAnsys’ European branch.
"This device offers hope to...
