June 15, 2021

Virtual Vital Signs—the Invasion of Medical Devices to our Living Rooms


In the recent years healthcare has significantly advanced with the development of mobile based medical apps. Such apps have facilitated communication amongst doctors, hospitals, medical insurance companies and patients. Medical devices, once restricted to a hospital or clinic, are now evolving to interface with these apps. In women’s health, a woman’s smartphone and her medical chart have already been intertwined!

Telemedicine is extending a clinician’s reach, and the line is blurring between what is a medical device and what is a health app, because medical apps are deemed regulated medical devices when they:

• perform patient-specific analysis
• provide patient-specific diagnosis or treatment recommendations
• can assist in the prevention of diseases
• help in mitigating complications if any

Consider the following:

Pregnancy books such as “Taking Charge of Your Fertility” by Toni Weschler, have a companion app- OvaGraph, where a woman can chart her fertility online.

The Wheel RE, by eNATAL LLC is an app that displays the same wheel used by obstetricians. A couple can follow the pregnancy with the obstetrician or midwife on a daily basis that identifies the last menstrual period, ovulation, quickening, weeks of gestation, lunar months, and estimated fetal weight along the journey.

Ovuline offers two apps, Ovia Pregnancy and Ovia Fertility, which help women track their pregnancy and fertility through iOS and Android apps.

On the hardware front, tangible technology can help you feed in, record, and track data into apps. Bluetooth technology in the nfant® Mobile App, interfaces with a special measuring accurate infant intake, stored in the cloud nfant® Patient Database. Feeding data is accessible to a pediatrician concerned with a baby’s nutrition or failure to thrive.

AirStrip provides wireless maternal-fetal monitoring for high-risk pregnancies. A woman’s doctor can access her baby’s heart rate and her contractions to assess important and timely biometric data.

“Computers were invented to count things. Apps were invented to organize the numbers and paint them pretty for us”

Instead of patients having to wait until their appointments to provide data that is sporadic, medical devices can now come to them, rendering continuous streaming data; health apps are the latest input/output for them. The merger of the two is emphasized by the need to standardize and regulate the association, with guidance for app developers:

Mobile Medical Applications – Guidance for Industry and Food and Drug Administration Staff
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices – Guidance for Industry and Food and Drug Administration Staff
• FDA Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance for Home Uterine Activity Monitors
Quality System (QS) Regulation/Medical Device Good Manufacturing Practice
• Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

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