A key milestone for mobile medical imaging: FDA approves mobile radiology viewer & smartphone ultrasound probe
Two key announcements last week should have physicians excited about the future of mobile medical imaging. FDA approval of a radiology viewing app and approval of a smartphone connected ultrasound probe peripheral.
Last week the FDA announced the first FDA approved diagnostic radiology app for mobile devices — Mobile MIM. We held off on announcing the news because we had read several reports last year stating another another diagnostic radiology app had been approved by the FDA already, ResolutionMD. We never reported on this because of the lack of information from the FDA.
We profiled ResolutionMD last year when it was announced Health Canada (analogous to the FDA) had approved the mobile app for diagnostic radiology viewing purposes.
In order to clarify this we spoke with the FDA and they told us the only mobile app they have approved for radiology diagnostic purposes is Mobile MIM, and that ResolutionMD’s mobile app is currently not approved by the FDA.
In its press release, the FDA stated Mobile MIM is not intended to replace DICOM workstations, and should only be used when a workstation is not available — e.g. when not at the hospital. From details provided in their press release, it’s clear the FDA did comprehensive testing of the device on multiple mobile devices, not just the iPhone. They tested luminance, resolution, and noise with multiple radiologists under various levels of lighting conditions. All the radiologists agreed the app was sufficient for diagnostic imaging interpretation.
From the press release:
The Mobile MIM application includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions. The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen. If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician’s ability to discern subtle differences in contrast. In addition, a safety guide is included within the application.
Ultrasound Smartphone Peripheral:
Last year we reported on a Smartphone based Ultrasound peripheral, MobiUS, from Mobisante, an mHealth company based in Redmond, WA. The device allows an ultrasound probe to be connected to a smartphone via USB 2.0 support. Last week they announced they had received FDA approval of the device.
Unfortunately, based on its form factor, MobiUS will not work on the Apple iPhone or on Android phones. The current setup of the medical peripheral requires USB 2.0 support. MobiUS will only work on the outdated Windows Mobile 6.5 OS with a Toshiba TG01 smartphone. Hopefully Mobisante is working on offering support to a wide variety of smartphone devices because limiting the ultrasound peripheral to one device significantly reduces its appeal.
The probe + phone combination will cost under $8,000 — less then some ultrasound devices that can cost tens of thousands of dollars. The company’s PDF file on the specs of the device do not contain too many specific product details of the probe. There are sample images available on their website that offer a better glimpse into the picture quality of the device.
Last week the FDA announced the first FDA approved diagnostic radiology app for mobile devices — Mobile MIM. We held off on announcing the news because we had read several reports last year stating another another diagnostic radiology app had been approved by the FDA already, ResolutionMD. We never reported on this because of the lack of information from the FDA.
We profiled ResolutionMD last year when it was announced Health Canada (analogous to the FDA) had approved the mobile app for diagnostic radiology viewing purposes.
In order to clarify this we spoke with the FDA and they told us the only mobile app they have approved for radiology diagnostic purposes is Mobile MIM, and that ResolutionMD’s mobile app is currently not approved by the FDA.
In its press release, the FDA stated Mobile MIM is not intended to replace DICOM workstations, and should only be used when a workstation is not available — e.g. when not at the hospital. From details provided in their press release, it’s clear the FDA did comprehensive testing of the device on multiple mobile devices, not just the iPhone. They tested luminance, resolution, and noise with multiple radiologists under various levels of lighting conditions. All the radiologists agreed the app was sufficient for diagnostic imaging interpretation.
From the press release:
The Mobile MIM application includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions. The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen. If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician’s ability to discern subtle differences in contrast. In addition, a safety guide is included within the application.
Ultrasound Smartphone Peripheral:
Last year we reported on a Smartphone based Ultrasound peripheral, MobiUS, from Mobisante, an mHealth company based in Redmond, WA. The device allows an ultrasound probe to be connected to a smartphone via USB 2.0 support. Last week they announced they had received FDA approval of the device.
Unfortunately, based on its form factor, MobiUS will not work on the Apple iPhone or on Android phones. The current setup of the medical peripheral requires USB 2.0 support. MobiUS will only work on the outdated Windows Mobile 6.5 OS with a Toshiba TG01 smartphone. Hopefully Mobisante is working on offering support to a wide variety of smartphone devices because limiting the ultrasound peripheral to one device significantly reduces its appeal.
The probe + phone combination will cost under $8,000 — less then some ultrasound devices that can cost tens of thousands of dollars. The company’s PDF file on the specs of the device do not contain too many specific product details of the probe. There are sample images available on their website that offer a better glimpse into the picture quality of the device.
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