Farm Blog

Five Promising Medical Device Mobile Apps

The medical device industry is likely on the cusp of a significant technology surge, one that merits close attention from device manufacturers, designers, and investors. Medical apps for mobile Apple and Android platforms continue to be developed at a rapid rate. But what’s new and noteworthy is that these apps are starting to evolve from information-only tools for consumers and clinicians – think calorie counters, clinical reference guides, or physical fitness support – to actual medical devices. Such apps are likely to change the future face of medicine.

The FDA stepped in with its July 2011 draft guidance on mobile medical applications. It carves out what the FDA calls a “small subset” of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices, distinguishing them from ones that merely support healthcare decisions or tracking. Examples of mobile medical apps that the FDA considers subject to regulatory oversight are:

• Those used as an accessory to medical devices already regulated by the FDA, for example, an app that allows a clinician to make a diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or mobile tablet; and
• Those that transform mobile devices into regulated medical devices by using attachments, sensors, or other peripheral devices, for example, an app that turns a smartphone into an ECG machine to detect abnormal heart rhythms or to determine if a heart attack is occurring.

Happily, the FDA has already approved a few mobile medical devices, signaling its awareness of how important it is to not block the wave of future mobile medical devices. It’s not hard to understand why this wave is likely to break big. According to one study, 80% of physicians already routinely use some sort of smartphone during their workday. Another study predicts that by 2015, 30% of the world’s smartphone users will use mobile health apps, up from 5% today. So the sheer numbers involved are one driver of this trend. But equally significant is the potential that mobile medical devices have for improving the life of those with poor access to healthcare—for example, rural areas of the U.S. or third-world countries. Their ubiquity and portability will help bring medical care to places where expensive equipment would likely never go, improving access while lowering costs.

Let’s take a look at five promising mobile medical devices:

1. Mobile MIM – Approved by the FDA in February 2011, this app allows physicians to view medical images on their iPad, iPhone, and iPad touch. It facilitates medical diagnoses based on CT, MRI, and PET images. Its portability enables clinicians to “immediately view images and make diagnoses without having to be back at the workstation or wait for film,” notes William Maisel, M.D., chief scientist and FDA’s CDRH deputy director for science.
2. AirStrip OB, Cardiology, and Patient Monitoring – AirStrip Technologies offers FDA-approved platforms that allow patient-critical information to be accessed by physicians/nurses using smartphones or tablets. It permits mobile transmission of information, including ECGs, maternal/fetal waveforms, vital signs data, and peak ventilator pressures. Remote real-time viewing allows anytime, anywhere clinical decision-making.
3. Mobisante – Recently FDA-approved, Mobisante utilizes a peripheral attachment to convert a smartphone into a small, portable, and accurate ultrasound machine. The attachment costs $7,495, and while the images are not as crisp as top-quality ultrasound machines, those cost much more, according to Jason Wagner, MD, an ER physician who reviewed this device. These medical devices are targeted for physicians on field calls or in remote areas.
4. iPhone ECG – AliveCor, developer of the iPhone ECG, kicked up a real stir when its video demo went viral on the internet. It has developed a device that transforms any smartphone into a clinical-quality electrocardiogram (ECG) recorder. It is described as a single lead that attaches to the back of an iPhone and displays heart rate information via an app. This medical device has not yet received FDA approval, but the company recently announced that it raised $3 million in its first round of funding.
5. Handyscope – This iPhone peripheral converts the smartphone into a dermatoscope. It slides onto the phone and magnifies its camera up to 20x. A concurrent Handyscope app assists in diagnosis and clinical decision making. Not yet FDA approved, these medical devices could be invaluable tools for skin cancer screening in rural areas.

In the course of research for this blog, it’s clear that there are lots of other promising mobile medical devices out there that haven’t yet moved from idea to actuality; it’s even more abundantly clear that this is an incredibly rich field for innovation and one that the medical device industry should embrace.