medical device

By Jonah Comstock April 26, 2018
This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for comments by the end of May), the publication comes with some long-awaited details about how the program might work. The document lays out five "excellence principles" on which companies applying for...
May 30, 2017
A recent report from security firm WhiteScope describes more than 8,600 flaws in pacemaker systems and the third-party libraries that power various components of the devices. The broad list of flaws includes a lack of encryption and authentication, simple bugs in the code and poor design that can put patient lives at risk. These vulnerabilities were associated with outdated libraries used in...
By Jonah Comstock February 6, 2017
Wearable activity tracker company Jawbone has been in dire straits for the better part of a year now, losing key executives, dumping its speaker business, reportedly selling out of its inventory (the company has fervently denied those reports), and not announcing any new products for several years. Last we heard, the company's planned hail mary was a more clinically-focused wearable, likely...