Concussions have long found their way into mainstream medicine but diagnosis and long-term impact remain difficult.
But Medtech is beginning to provide answers. As we explained back in the spring in our report “Eight Medtechs Tackling Head Concussion,” Medtech start-ups are developing new methods of examining brain injury with an eye toward helping physicians diagnose concussions.
One of those companies, BrainScope Company Inc., just announced that the FDA has cleared the firm’s third-generation diagnostic tool, Ahead 300. In this week’s Medtech Talk Podcast, BrainScope CEO Michael Singer details the start-up’s eight-year journey to develop the device and reveals its next plans.
“We made the decision to commercialize this version,” Singer said. “We will now be pivoting from a pure R&D to a commercial organization with continuing R&D as well.”
In the podcast, Singer discusses:
- How the company secured close to $30 million from the Department of Defense and NFL.
- What steps it had to take to satisfy the clinical trials demands of the FDA.
- Whether or not the company will be seeking a strategic partner to sell the Ahead300.
BrainScope’s Ahead 300 features electroencephalography (EEG) capabilities that employ sophisticated algorithms and machine learning to analyze head-injured patient data. The system is accessed via a smartphone connection.
Singer says the Ahead 300 device doesn’t provide a binary positive or negative diagnosis. “What we are providing is all kinds of clinical data to allow them to make that decision,” he said. “We are not telling the clinician that the patient is concussed… We are giving them all kinds of objective capabilities to make their clinical diagnosis, and there is nothing like that today.”
Michael Singer
CEO
BrainScope
Michael Singer has over 25 years of executive leadership with significant operating, healthcare and financial experience.
As CEO of BrainScope, Michael has guided the company from technology development, clinical studies, product validation, Intellectual Property creation, organizational build, and multiple regulatory clearances to commercial launch of the first FDA-cleared medical device for assessment of the full spectrum of brain injury, including concussion. Michael also secured significant equity investment and research funding through government and military research contracts.
Before Michael joined BrainScope, he was President of Revolution Health Investments, where he managed its sale to Everyday Health. He was previously the Chief Financial Officer, Executive Vice President of Corporate Development for Data Critical Corporation, a Seattle-based venture-backed medical device company. At Data Critical he was responsible for facilitating the company’s IPO and eventually led the sale of Data Critical to General Electric (GE). He has also worked as an executive at Microsoft Corporation responsible for developing small business and healthcare strategies. For a decade Michael was a healthcare investment banker and M&A generalist for Wolfensohn & Co., Alex. Brown and Montgomery Securities in New York and San Francisco. He started his career at Union Bank of Switzerland in Zurich.
Michael has served on the Board of Directors of Exact Sciences Corporation (molecular diagnostics), MedEfficiency (medical devices, sold to Derma Sciences), SparkPeople (consumer health), One Reel (entertainment), and Data Critical Corporation (medical devices, sold to GE), and currently serves on the Advisory Board of the Maxwell School of Citizenship and Public Affairs. He holds a Ph.D. from the London School of Economics.
