There were 31 FDA clearances for mHealth devices in 2014. There are three that stand out for digital health marketers.
- Both Samsung and LG Electronics acquired certifications for devices. Samsung’s was a “cardiology signal transmitter” and LG’s was somewhat more mysterious and listed as “LG Smarthealth.” The fact that two large Android manufacturers have gone the 510(k) route whereas Apple has worked diligently to avoid certification shows the differences in the strategies. It will be interesting in 2015 to see if one of them pulls ahead because of this difference.
- The Dexcom Share allows for caregivers to track the glucose levels of a loved one and Vital Connect handles nine different measurements from the bandaid-like HealthPatch. The caregiver segment will probably see more innovation in 2015.
- Gauss Surgical achieved certification for an app that uses the built in iPad camera to estimate blood loss during surgery. Apps that use only the built-in equipment on mobile devices will only become more common as these devices, especially smartwatches, add more health-specific sensors.