February 2015

FDA Authorizes 23andMe to Market Genetic Testing For Bloom Syndrome

The FDA has classified the Bloom Syndrome carrier screening tests as class II, meaning the kits have special controls in place for direct-to-consumer marketing. The kits are also intended for exemption from FDA pre-market reviews, according to the FDA. “The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health said.

That last quote is really interesting.

Asthma Whistle

My new project. Working on making asthma management for children really simple.

If you’re interested go to the site and subscribe to the newsletter.

Scripps will use mHealth to safely monitor Ebola patients

The San Diego-based health system is partnering with three mHealth vendors to create a sensor array that can safely and continuously monitor not only those infected with the deadly disease, but those who may be at risk of an infection.

Minimizing the risk for everyone. Brilliant.

Impressive Accuracy of Devices to Track Physical Activity Data

We found that many smartphone applications and wearable devices were accurate for tracking step counts. Data from smartphones were only slightly different than observed step counts, but could be higher or lower. Wearable devices differed more and 1 device reported step counts more than 20% lower than observed.

I’m impressed. I didn’t realize smartphones were this accurate.

Healbe GoBe Review Spoiler: It Doesn't Work!

GoBe’s main crime? It doesn’t deliver on its most exciting feature.

It’s a total crapshoot.

FDA once again steers clear of health IT, finalizes plans to stop regulating some medical software

Bravo for not impeeding innovation.

“The MDDS guidance confirms our intention to not enforce compliance with applicable regulations for technologies that receive, transmit, store, or display data from medical devices. We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data,” wrote Jeffrey Shuren, the head of the FDA’s device arm (CDRH), and Bakul Patel, its associate director for digital health, last week on the FDA’s blog.

The European agencies should take a page out of FDA’s book on digital health regulation.