Jan Medical has teamed up with the U.S. Army Medical Material Agency to get an indication for a test that can detect brain disorders and injury, including concussions. The Mountain View, CA-based company said in a release that it has conducted its first user feedback session for the BrainPulse device as part of the agreement with the Army.
Simulations were performed to replicate how BrainPulse would be used in the battlefield by medics and physicians. Due to its small size, portability and battery power source, the company said BrainPulse is ideal for transportation and may be considered for use as a triage tool in Battalion Aid Stations and medical treatment facilities. BrainPulse has De Novo Clearance from FDA for cranial motion measurement. The partnership with the Army would help the company get the concussion detection indication.
“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," said Brian Dacanay, Product Manager at the U.S. Army Medical Materiel Agency, a subordinate organization of the U.S. Army Medical Research and Materiel Command, in a prepared statement. "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.”
Here’s how the device works. Blood flow to the brain during each heartbeat is not symmetrical due to the distribution of arteries into the head, which cause the brain to oscillate inside the skull. With highly sensitive sensors in the headset, BrainPulse is designed to detect any abnormalities in this oscillation, which may indicate disease or injury. Jan Medical said the results are then analyzed by algorithms and displayed on a touchscreen tablet for the physician, nurse or trained medical personnel to interpret. The company said the whole process, from set-up to a complete recording, takes between three to five minutes.
Brain Injury Market is Hotbed of Activity
There has been intense interest in diagnosing concussions and traumatic brain injury (TBI) in recent years. A study published in the March 2017 edition of The Journal of the American Medical Association showed that at least some form of TBI was diagnosed in 87 percent of donated brains of 202 football players. The NFL in particular has been plagued with lawsuits regarding Chronic traumatic encephalopathy.
This has led to many companies developing technologies for the growing space. FDA’s response has been swift too, as it has cleared and approved a number of devices and diagnostics that can give greater insight, if not outright detect TBI in patients.
Nearly two months ago, FDA cleared the Banyan Brain Trauma Indicator, the first blood-based TBI detection test. San Diego-based Banyan Biomarkers developed the assay. Banyan’s diagnostic test works by identifying two brain-specific protein biomarkers (Ubiquitin Carboxy-terminal Hydrolase-L1 or UCH-L1 and Glial Fibrilliary Acidic Protein or GFAP) that rapidly appear in the blood after a brain injury.
In 2016, FDA cleared two medical devices, the first to fall into the new computerized cognitive assessment aid for concussion device category. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric devices from Pittsburgh, PA-based ImPACT Applications are computerized tools used to test a person's cognitive function after a possible concussion.
However, the tests don't actually diagnose concussion. Instead they can be used to determine how a person's thinking may have been impaired by a possible brain injury. Patients are tested on measures like word memory and recognition as well as reaction time. Their performance is compared against their own results before injury or to database scores from other people their own age.
FDA also cleared a virtual reality, eye-tracking headset that can detect concussion symptoms in less than 60 seconds. Eye-sync, from Boston-based startup Syncthink, is the product of years of research by the Stanford concussion and brain performance center at Stanford school of medicine.