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Mobile medical apps are changing our health care system; rapidly and drastically.

Posted on December 30, 2013 · Posted in Medical Device Trends

Did you know, the FDA cleared over 100 medical apps in the last 10 years? 40 of these apps were cleared in just the last 2 years.

The medical app environment is showing great signs of not only growth but providing great innovation in our health care treatment and delivery systems.
This is an area of development that both new and existing medical device companies should consider moving into.

The sub-industry is ripe for gaining access to investment and grant dollars. The beauty of this type of innovation is that the product type fits both the technology and medical sectors. It’s the technology side of the coin that interests these investment groups.

Another advantage to developing low-risk medical apps is that the FDA regulatory environment is designed in such a way that the barriers to market entry are lower than some other medical device categories.

If the device falls outside of the items mentioned below, the regulatory hurdles may be minimal or non-existent if the apps Primary Mode of Action (PMOA) does not meet the requirements/definition of a medical device.

The FDA is focusing its oversight on mobile medical apps that:

1. are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
2. transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.

You can read more about the final FDA mobile app guidance issued on September 25, 2013.

Image courtesy of; 7/2/12 mobile app post.