medical device

By Tammy Lovell 05:57 am November 13, 2019
Health tech manufacturer Phillips-Medisize has announced the opening of a global innovation and development centre in Copenhagen, Denmark to support its long-term growth plans for advanced injection, wearable devices and connected technologies. The Molex company says it plans for the centre, based in the Teknikerbyen area, to help accelerate the creation of differentiated drug delivery devices...
By Laura Lovett 03:32 pm July 16, 2019
The stakes are high when it comes to medical device safety, but recall notifications aren’t always easy to find. With this in mind, a new Boston-based startup called Soom is aiming to target this issue with its new app, called SoomSafety. The app lets users scan the bar code of a medical device to bring up all safety and recall information about the product. Soom pulls from the FDA’s open-source...
By Jonah Comstock 04:43 pm 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...
03:13 pm 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 These vulnerabilities were associated with outdated libraries used in...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 02:06 pm 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...