Remote patient monitoring company HealthInterlink received FDA 510(k) class II clearance for Beacon 2.0, a mobile-centric software system that integrates data from various home health devices. Beacon was previously cleared as a class I medical device (MDDS). HealthInterlink plans to begin commercialization of the device in the US immediately.
Beacon 2.0 works on tablets, smartphones and via texting. The software system integrates with patients' connected medical devices including blood pressure cuffs, spectrometers, thermometers, pulse oximeters, glucometers, and weight scales. This information is sent through HealthInterlink's server to a healthcare provider's tablet, laptop or desktop.
Multiple patients can share one Beacon system.
“We see this clearance as a major milestone in helping make chronic care more convenient and less disruptive for patients,” Danna Kehm, Managing Director of HealthInterlink said in a statement. “Regulatory clearance of our software shows that it performs equivalently to a traditional bulky monitor and helps us move towards our bigger vision of reimagining chronic care with mobile devices in a mHealth world.”
HealthInterlink sells its software as part of a custom kit, which contains a combination of tablets and remote monitoring devices that the user may need to use Beacon. The standard kit comes with a 10.1" Android tablet or a 7" tablet (with FDA-cleared medical devices as well), but the company said they would work with patients to provide them with a kit that suits their needs.
In July 2013, Juniper Research predicted that remote patient monitoring will save the world’s healthcare systems up to $36 billion by 2018. The report goes on to say that smartphones and connected devices will grow more rapidly than dedicated, non-smartphone-connected mobile health devices.