The decline in cognitive health, especially that leading to Alzheimer’s and other brain diseases, is one of the most feared conditions by patients and their families. It’s also one of the most expensive. But if we can predict it early there are things we can do to prevent or ameliorate it. The issue has been finding an easy and comprehensive way to monitor it as part of primary care. The team at Linus Health has been building a diagnostic solution for exactly that and claims that it’s now the right time to roll it out as part of general primary care. CEO David Bates, John Showalter, Chief Product Officer (a primary care doc) and Alvaro Pascual Leone, a neurologist and Chief Medical Officer, took me through an extensive end to end demo. This is a long and fascinating look at the state of play in neurology diagnosis, and discussion about what the future of brain health looks like. Matthew Holt
The FDA & Me (or How to Explain Your Test Isn’t a Game)
So you have a great idea for an app. Not so fast: it took two years and over half a million dollars to get ours cleared for marketing by the US Food and Drug Administration (FDA).
Our app, DANA uses a mobile phone to records peoples’ reaction time during game-like tests. It also provides questionnaires that help clinicians evaluate brain health. Commissioned from AnthroTronix by the Department of Defense, the app will help diagnose concussion, depression and Post-Traumatic Stress Disorder (PTSD).
For something so important, a serious investment of time and money for clearance may not sound extravagant, but few small companies can afford a two-year go-to-market delay, not to mention the significant investment and heartache that goes with it. And although the FDA has tried to facilitate regulation by providing guides like the Mobile Medical Applications Guidance Document and the Mobile Medical Applications website, the regulatory process remains confusing.
Here are five simple lessons from our own experience that will help other entrepreneurs to do the right thing and engage with the FDA:Continue reading…
