Med Device Monday: BrainPulse 1100

When blood flows through our bodies, it creates motion and movement. A new device is able to register and measure these tiny movements through sensors on the skull, and help derive health information from it. I've said it before and I'll say it again: living in the future is pretty great. 

Recently approved via the de novo pathway, the BrainPulse™ 1100 is a headset with an attached computer that collects and extrapolates information "by sensing small signals created by the effect of brain oscillations on the skull. The system senses these signals in the subject’s head via sensitive passive sensors (accelerometers), which are an integral part of the headset. The accelerometers convert the skull motion to very low-level analog electronic signals. The data collector then digitizes the analog signals. The digitized signals are passed to the computer where the software creates a data file. The data file is then stored in the computer."

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Jan Medical, the company behind the Brainpulse™ 1100, explains that blood going to the brain creates a pulsing pattern that has a predictable rhythm. Problems like concussion, ischemia (inadequate blood supply to a certain area, tissue, or organ), and dementia create predictable patterns of disruption in this pulse. Data is taken through the headset, sent through a cloud-based algorithm, and then sent to the tablet computer attached to the headset. What might be most impressive is that all of this takes only 45 heartbeats and three minutes to do: healthcare professionals have the information they need quickly to help them make a diagnosis and appropriate treatment plan.

Let's look a little more closely at how BrainPulse™ can help with concussions. The Brain Injury Association of America explains what concussions are: "The Centers for Disease Control and Prevention (CDC) defines concussion as a traumatic brain injury (TBI) caused by a bump, blow, or jolt to the head or by a hit to the body that causes the head and brain to move rapidly back and forth. This sudden movement can cause the brain to bounce around or twist in the skull, stretching and damaging brain cells and creating chemical changes in the brain." It's easy to imagine, then, how such a disruption in the brain would register in the "traffic pattern" of the brain's blood flow. Importantly, the clinical benefit of the BrainPulse™ goes beyond an initial quick diagnosis.

As the company explains, "Concussion is an everyday concern for up to 2.6 million student athletes in the US, with an actual occurrence of up to 300,000 annually. A second concussion incurred while recovering from an initial concussion, otherwise referred to as Second Impact Syndrome (SIS), can be lethal. While cognitive tests are generally effective at diagnosing an initial concussion, they do not provide the assurance that a physiologic test would in grading the severity of the injury or, more significantly, in making return-to-play determinations. The expectation is that the BrainPulse™ 1100 will have the capability of identifying not only an initial concussion, but to also track the crucial course of recovery and return to baseline." Using technology to get information more quickly and accurately in a way that's never been done before is a pretty exciting part of the medical device world these days. Jan Medical has continued to explore this with various clinical studies, including one study that is following students with concussions and monitoring them with this equipment for about a year.

Further reading:

FDA Classification Order for BrainPulse™ 1100

FDA Decision Summary for BrainPulse™ 1100