RPM Device With CCIQ
ChronicCareIQ recognizes the growing importance of remote patient monitoring in this increasingly digital age. That’s why we are proud to offer integrations with RPM devices from the companies listed below:
Preferred Device Vendors:
Other Device Vendors:
BodyTrace (Less support for reading management/no ability to sync past readings)
Telli Health (Less support for reading management/no ability to sync past readings)
MioConnect (Less support for reading management/no ability to sync past readings)
Life 365 (No Longer Supported)
Live Care (No Longer Supported)
Live Metric (Coming Soon)
CCIQ API (For device measurements only)
Standard RPM device fee of $2.50 per device; no additional API usage fees
Please email [email protected] with any questions regarding our current or potential device integrations.
FDA Regulations For RPM Devices
FDA-RPM Medical Devices
Section 201(h) of the Food, Drug & Cosmetic Act Definition: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar.
Medical Devices are divided into three Classes and forms of acceptance
RPM devices are Class II, 510(k) required notification
RPM devices require “FDA definition of medical device” and collect/transmit reliable and valid physiologic data automatically
Patient Scales Are EXEMPT
Title 21-Chapter 1-Subchapter 8
Patient Scales are EXEMPT from Medical Device Requirement
Scales CAN be used for RPM monitoring without “FDA Clearance” Status
Different Types Of FDA For RPM Devices
FDA Registered – ONLY means manufacturer known, NOT devices known
FDA 510(K) – MOST RPM DEVICES here – legally required to market/sell
FDA Cleared – same technology already exists, used for the same purposes
FDA Approved – for Class III devices with lengthy process (ie, implantables)
Helpful Articles & References
You can find more information on RPM devices and FDA regulations for these devices in the articles and references linked below: