Technology Innovation and Signal Processing Refinements Providing the Path to Commercialization according to Greystone Research Associates
Several companies are pursuing noninvasive monitors capable of rendering and reporting relative values of key brain health indicators, including intracranial pressure (ICP), cerebral tissue oxygenation and cerebral blood flow, without the need to disturb the cranium. These devices utilize a range of diagnostic modalities that include ultrasound, near infrared spectroscopy, impedance and acoustics. The global market for these monitors will exceed US $250 million in 2019, Greystone Research Associates forecasts in a new report.
The ability for clinicians to measure key brain health indicators noninvasively has long been an unmet need that contributes to patient morbidity and mortality. Patients experiencing traumatic brain injury (TBI) are at risk of progressive trauma due to secondary factors directly or indirectly related to the initial insult. But monitoring these patients continues to prove difficult, as caregivers find themselves limited to relying on methods and techniques first employed decades ago. ICP, a key indicator of brain risk post-admission, can provide valuable information directly related to patient outcomes if monitored continuously, but monitoring this parameter still requires invasive techniques that result in their use being restricted to only a small minority of cases.
There are currently six devices for noninvasively monitoring one or more neurological parameters linked to brain injury that are approved for marketing under the FDA’s 510(k) approval process. Two-thirds of these are approved for cerebral tissue oximetry, another important indicator of injured brain health. Only one device is currently approved for monitoring ICP, but two additional devices are currently recruiting patients for new clinical trials.
One of the key factors that will impact the commercial success of noninvasive brain monitors is the rate of caregiver acceptance. A prerequisite of acceptance will be the level of confidence clinicians can achieve with regard to the accuracy of the measurements. To reach this tipping point, more evidence will be needed to demonstrate the accuracy and reliability of noninvasive brain monitors against verifiable values.
These developments are examined in a new and comprehensive report written and researched by Greystone Research Associates. Noninvasive Brain Monitors: Devices, Markets, Strategies and Prospects includes technology analysis, device assessments, market data and forecasts, and market sector participant profiles.