Biopharma Business

Health monitoring smartphone system readied for FDA approval by Leman Micro Devices

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Health monitoring smartphone system readied for FDA approval by Leman Micro Devices

February 20
12:41 2017

Developer of consumer healthcare products, Leman Micro Devices (LMD) has announced that its Health Sensor & App will be submitted to the FDA for approval.

The app allows users to measure blood pressure and other vital signs with, what the company state, medical accuracy.

Unlike the standard technique of using a cuff to measure blood pressure, the app measures it by having users push their fingers against a sensor built into the smartphone. Other features include reading of users’ body temperatures as well as blood oxygen saturation, heart rate and respiration rate. The measurements can be performed anywhere at any time in under 60 seconds, without a need for extra accessories, LMD claim.

More so, the use of the app under conditions that the user finds favourable negates the risk of ‘White Coat’ syndrome, where a patient’s blood pressure level is higher due to the clinical setting in which the reading is taken.

LMD CEO, Mark-Eric Jones said: “The world is ready for smartphones that come with a built-in medically-accurate heath monitoring system, rather than current products which are not approved and often inaccurate. Most wearable devices do not measure health at all, only activity, while other solutions carry a hefty price tag. Yet the market is immense – Apple’s CEO Tim Cook says healthcare products could ‘dwarf’ the smartphone market – and we believe that just as today no one would buy a smartphone without a high quality camera or GPS, very soon users will expect accurate healthcare functions to be included in the package.”

“Our product is proven in the lab and already the FDA has ruled that it is our device, not the smartphone itself which is the regulated element – in this instance, the smartphone is regarded as an ‘accessory’. We expect to submit our Health Sensor & App for full approval and certification later this year.”


Written by Reece Armstrong

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