An app by Israeli health-tech firm Voyant, to help doctors plan hip replacement on mobile devices, was granted FDA approval this week as a Class II medical device (requiring regulatory controls to provide reasonable assurance of the device’s safety and effectiveness).
With this app, doctors can import images from secure hospital networks, insert digital implant images to determine the best surgery techniques for each case, visualize an operation, and use the resulting data for review or consultation.
In a statement, Marc Mackey, general manager of orthopedics at German firm BrainLab, which acquired Voyant in 2001, said that Voyant’s TraumaCad platform, in use on desktops for over a decade, is very popular among surgeons, and “with the mobile version of TraumaCad, digital templating can now be accessed from any web browser or iPad, enabling surgeons to be more productive while also providing access to data for better inventory management.”
TraumaCad is the latest in a growing number of apps that are being used by iPhone- and iPad-bearing doctors, nurses, hospital administrators, and other health professionals. Already, dozens of apps have been approved as medical devices by the FDA, since the US agency began requiring such approval in 2013.
Many of these apps, such as the one that receives data from the Kinsa oral or rectal thermometer, work in conjunction with actual devices. Other apps connect to wristbands, radiology units, blood-pressure monitors, and other devices.
An Israeli device of this type made by EarlySense recently received FDA approval as well. EarlySense’s Chair Sensor monitors patients who are sick enough to require continuous tracking, but are unwilling — or do not need — to be connected physically to monitors and sensors. Designed for use in non-emergency room or even home settings, the system uses sensors embedded into a mattress or chair cushion to monitor heartbeat, respiration rate, and movement — the theory being that the more a patient moves around in bed, the healthier they are, in general.
The data is transferred to a monitoring station, either local or remote, with the system setting off alarms in the event that something appears amiss. In use in thousands of hospitals, nursing homes and home settings around the world, and according to hospital studies, over 90% of staff said that the system was useful in stemming and preventing patient deterioration.
The FDA approvals are a harbinger, many industry experts believe, of Apple’s entry into the medical-device business — which could be the result of the company’s new ResearchKit, a platform that will enable iPhone owners to use their devices to measure, record, upload, and analyze all sorts of data about their health. Announced last month by Apple CEO Tim Cook, the platform could turn Apple products, such as the Apple Watch, into devices that collect and analyze information about blood pressure, glucose levels, and Parkinson’s disease, among others.
That could be a problem for Israel, which has a significant medical-device industry. As with other devices — music players, Internet browsers, messaging devices (pagers) — that have “folded into” the IoS platform, it’s possible that Apple could develop apps and offer peripherals that will take the place of oxymeters, blood-pressure monitors, and diagnostic tools, much like the one developed by Voyant.
With 700 million iPhones out there, does that mean Israel’s medical-device industry is now in competition with a behemoth that has the money, marketing, and moxie to take over the market?
Not necessarily, according to D. Todd Dollinger, CEO of the Trendlines Group and one of Israel’s leading experts on medical devices. The Trendlines medical incubator, headed by Dollinger, was named Best Incubator by Israel’s Office of the Chief Scientist in 2010, and again in 2014.
“The new Apple platform looks like a great way to gather data — which may or may not turn out to be a good idea,” said Dollinger, “but I don’t see it taking on advanced characteristics of medical devices, at least in the near future.”
What’s going to make or break the iPhone and iPad as medical devices is the software that manages the data that the Apple Research Kit platform will collect — and that is a business Israel excels in, Dollinger claims. “I really see this as a platform to gather data. In the past, it took years to build a body of data on patients with a specific medical condition. Now, in just a day you could have more data than you would have been able to collect in a year.
Of course, more data that is more accessible to more people could mean bad statistics and worse conclusions — but I think a lot of good will come out of it.” Despite that, Israel’s medical-device business is safe. “The iPhone is a tool,” added Dollinger. “It is not going to replace the advanced medical devices we produce in Israel.”