Jan Medical said today that it has launched a cooperative research and development deal with the US Army Medical Materiel Agency to evaluate its BrainPulse device.
Jan Medical’s BrainPulse device is designed to non-invasively capture novel physiological signals through a patient’s cardiac output, used to measure vascular and brain tissue conditions, the company said. The data can be used as an ‘aid to diagnoses’ for multiple indications, including concussion and stroke.
Initial testing as part of the R&D program was completed on March 9, with the first user feedback session conducted today, the Mountain View, Calif.-based company said. The user assessments were completed at Fort Bragg, N.C.
“The BrainPulse device by Jan Medical, Inc. was identified as a potential product through market research efforts based on the Federal acquisition regulation part 10. Our goal is to provide clinicians with the capability to non-invasively diagnose mild brain injury in field and pre-hospital settings. Unlike brick and mortar hospitals where conditions are controlled and ideal, medical devices may not operate in the field environment, especially when exposed to extreme environmental conditions. Making hardware or software modifications as the device is being developed will help assure that medical devices can operate in the field and reduces overall developmental costs. User feedback is essential because it allows developers to incorporate hardware and software modifications early in the process,” US Army Medical Materiel Agency product manager Brian Dacanay said in prepared remarks.
The company said its BrainPulse device has received FDA de novo clearance as a class II medical device for cranial motion measurement. As part of the deal, the US Army will provide regulatory guidance to Jan Medical as it seeks FDA clearance for a concussion indication for the BrainPulse device.
“Jan Medical is honored to be working side by side with U.S. Army based clinicians to advance our next-gen device. BrainPulse will provide diagnostic indicators for urgent brain disorders, including concussion, allowing for rapid diagnosis of head injuries in both military and civilian populations,” Jan Medical prez Ken Bruener said in a press release.