An international group of medical device regulators and stakeholders released a draft framework designed to harmonize regulation of software as a medical device, or SaMD, Health Data Management reports.

On Tuesday, March 27, 2014 the FDA published a proposed rule in the Federal Register that would update how the agency classifies medical devices, including mobile health technologies, Health Data Management reports (Slabodkin, Health Data Management, 3/25).

U.S. Food and Drug Administration issued final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA’s tailored approach to mobile apps.

Alere™ Connect has been granted a 510(k) market clearance by the U.S. Food and Drug Administration for the Alere™ MobileLink. The new product offering is one of Alere's connected device technologies designed to empower patients by allowing self-testing at home and delivering data quickly and seamlessly to clinical systems accessed by their healthcare providers.

Teratech Corporation today announced the launch of the new uSmart 3200T Ultrasound System, the first in Terason's uSmart family of proprietary products. This revolutionary new tablet, deemed "disruptive technology" by industry leaders, will change the way healthcare is delivered in both hospital and outpatient sectors of point-of-care ultrasound.

The AliveCor Heart Monitor gives you instant, portable screening opportunities. Utilize the device anytime, anywhere to evaluate heart rate and rhythm. The AliveCor Heart Monitor is cleared by the FDA for sale in the U.S. to licensed medical professionals and prescribed patients to record, display, store,
and transfer single-channel electrocardiogram (ECG) rhythms.

For more info check out their site: http://www.alivecor.com/en

FDA's Bakul Patel took the stage at the WLSA Wireless Convergence Summit 2013 using an iRobot RP-VITA to speak with the audience on the status of FDA's mobile health application regulations. It was a gesture as symbolic as it was quasi-futuristic. Patel could have just as easily conferenced in using Skype or Facetime (but then again this is a health conference). Likewise, given the current stage of FDA's draft guidance on mobile medical apps, one has to wonder if there might be a more convenient way...or at least one that brings up fewer questions.

Applications are now open for ZeroTo510, an entrepreneurship accelerator program designed to help start-ups bring medical device products and services to market. Applications will be accepted until March 25, 2013.

“Last year, ZeroTo510 was launched as the first-ever program of its kind in the United States focused on medical devices”