While doctors, other health care professionals (HCP), and us patients/”consumers” don’t yet have a Star Fleet medical tricorder like the one that Dr. Leonard “Bones” McCoy uses on Star Trek, we’re getting closer — by using smartphones as the off-the-shelf guts for new next-generation mobile medical devices.

“I use Liftpulse  and iSeismograph on my iPhone all the time, for diagnosing and measuring tremor in patients, like people with Parkinson’s Disease,” says Dr. George Plotkin, neurologist with the ETMC Neurological Institute in Tyler, Texas and ETMC FirstPhysician.

“New gigahertz-speed mobile CPUs let even a handheld device pack enough processing power for compute-intensive tasks,” says Sailesh Chutani, chief executive and co-founder and Mobisante, a company that sells ultrasound systems based on smart phones and tablets. “Before QualComm’s SnapDragon chips and its gigahertz computing, it wasn’t technically possible for us to do ultrasound imaging on a phone.”

Some of these mobile medical apps  make use of the sensors built into smartphone hardware. These days, that can mean not just microphone, camera, and GPS, but also things like accelerometer, gyroscope, magnetometer, proximity sensor and luxmeter, and even temperature, humidity and sensors.

Other mobile medical apps use increasingly affordable add-ons, like the EyeNetra.

And most can take use the HCP or patient’s smartphone, although some, like the MobiSante Ultrasound, currently come bundled with a Windows 8 phone as part of the package. (The company is working on Android and iOS apps versions.)

“Smartphone and tablets are being increasingly used for telemedicine and telehealth,” according to Roeen Roashan, an analyst with IHS Technology.

“Inexpensive, easy to use, connected medical diagnostic devices lets you equip primary care physicians and nurse-practitioners, clinics, urgent care centers, retirement homes and other locations with powerful tools, which in turn helps move care closer to the patient, and away from expensive settings like hospitals,” notes Mobisante’s Chutani. “It also means better point-of-care tools for EMTs and other first responders, so, for example, they can determine if a person is bleeding internally and needs a hospital ER rather than a clinic that’s closer.”

Diagnostic apps aren’t as simple as submitting to an app store

There’s no shortage of health and medical mobile apps and add-ons — over 100,000 for Android and iOS as of October 2013, says Dr. Douglas B. Kamerow, Senior Scholar in Residence, Robert Graham Center and Professor of Clinical Family Medicine, Georgetown University.

However, most of these are informational, like providing diet information or helping track exercise, or are e-book versions of medical books, education apps, etc., like to Skyscape’s free Medical Resources App used by doctors and other health care professionals.

Three factors control to the slow growth of mobile medical apps and devices. One, funding. Two and three, where required; clinical trials to see how well they work, intrinsically, and, ideally, compared to existing tools and techniques; and FDA approval.

The U.S. Food and Drug Administration has three Classes, and associated regulatory controls, for medical devices, based on factors including intended use, and how much potential risk using a device poses to a patient, with Class I being the lowest, Class III — e.g., heart valves — highest.

Only a very small number — maybe a few hundred, Dr. Kamerow estimates — have so far been approved by the U.S. Food & Drug Administration (FDA). “They are only evaluating a sub-set of apps that they categorize as ‘mobile medical apps,’ meaning, software and/or hardware that lets a mobile device like a smartphone or tablet become an accessory to a regulated medical device, or turns a mobile device into a regulated medical device.”

And, notes IHS Technology’s Roashan, “The intended regulation level for mobile medical apps is Class II. We have seen few mobile medical apps with Class II approval due to the costly process of obtaining by FDA approval. As mobile medical devices and apps become more advanced the risk levels will increase, which implies moving closer to Class III. We haven’t yet seen any Class III mobile medical apps, because the costs of the FDA approval process.”

One strategy for getting to market, notes Mobisante’s Chutani, is to start outside the United States, where certification procedures may be less daunting.
Here’s a look at some of what’s available, or still in the development/approval cycle.

Ultrasound with Mobisante

Ultrasound imaging is used for more than just “let’s have a look at your baby” and echocardiograms to routine screenings, guide needle placement for some treatments and other procedures, letting first responders check trauma victims (for pneumothorax), and more.

Standard clinical ultrasound systems can cost as much as $30,000 and up. Mobisante’s Ultrasound  currently using Windows smartphone or tablet (Android and iOS apps are being developed), including the cloud-side components and support, are far more affordable either to buy or rent, providing, says Chutani, providing about 70% of standard clinical functions for about one-third the cost.

A Case (or Puck) Of Health

Several mobile-connected devices can collect a handful of “vitals.”

Azoi’s ‘Wello’ Health Tracking Case,  available for iPhone and Android, tests and displays “vitals” like heart rate, temperature and “pulse-ox” when you hold it. (And can be used as a case for many iPhones.) At $199 (pre-order), not cheap, but affordable.

The Scanadu Scout  (not quite yet available) will assess blood pressure, temperature, respiratory rate, ECG, oximetry, all within ten seconds.

Ears To You: CellScope Otoscope

CellScope’s clip-on and app turns your iPhone’s camera into an otoscope — the dingus used to look in your ear. Aside from being used directly by doctors, the clip-on should be affordable enough for parents, clinics, school and day care staff, and others to have them, letting them send a picture of the ear view to a doctor to examine for signs of infection… reducing doctor visits for things like recurring ear infections.

A standard doctor’s optical otoscope can run $500 to $600, and a USB digital one $1,000 to $1,500. While CellScope pricing has yet to be determined, “We expect to be less expensive than the standard optical,” says Dr. Erik Douglas, CEO, CellScope.

Measuring Tremor

Apps like Lift Lab’s LiftPulse (Free, iOS) app and iSeismograph give doctors an easy, affordable way to measure and quantify “tremor” — a common symptom of medical issues like Parkinson’s Disease — using the accelerometers in an iPhone.

The Eyes Get It

Why sit patients in steampunk-torture-like chairs to check for eye problems when you could do it with a smartphone?

Vitor Pamplona in the MIT Media Lab’s Camera Culture research group has at least two (so far) promising inexpensive snap-ons that make use of smartphone cameras: the NETRA  (Near-Eye Tool for Refractive Assessment), and the CATRA.

NETRA, being worked on in Somerville’s EyeNETRA, replaces up-to-$45,000 devices, and can measure “refractive eye disorders,” which include near- and far-sightedness, astigmatism, and presbyopia — one or more of which nearly two billion people world-wide have. CATRA, similarly, will help diagnose cataracts, which are a leading cause of blindness.

Blood Glucose Measuring

Granted, blood glucose meters are already small and inexpensive (although the cost of the single-use test strips adds up), but the iBGStar blood glucose meter (around $70-$80 — not including packs of test strips) can be used with an iPhone or iPod Touch, or on its own.

Check Skin Spots

Are those moles or spots on your skin benign, or cancer? Apps and add-ons like Handyscope  and the app-only Doctor Mole help dermatologists decide.

Interpret Color Test Strip Results

Apps like Colormetrix and uChek  turn your smartphone into a portable spectrophotometer, analyzing the color of test solutions or strips used in medical, drug, environmental and other test situations. For example, checking results of a saliva, urine, blood or other body-fluid sample.

Conclusion

Not all of these medical doohickeys are available yet. Some are still in development and testing, some await sufficient funding (many have KickStarter or other crowdfund campaigns going). And many are still awaiting FDA approval, at least for use within the US.

Meanwhile, all smartphones have at least one medical diagnostic use: being used as a small hammer to test knee reflexes.

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