A personal EKG monitor, an app that wirelessly connects to a smart thermometer, and 3 more FDA-cleared apps for primary care.
The FDA's decision to regulate a health/wellness app as a medical device is based on whether the application has the potential to significantly expose a user to health risks if it fails to perform as intended. In March, our app reviewer chose 5 FDA-cleared apps that primary care physicians and patients could use and this month he has reviewed 5 more that can be used either coupled with a required medical device or on their own. We highlight:
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Eko: Digital Stethoscope + ECG is a HIPAA-compliant app that connects to the Eko digital stethoscope via Bluetooth and allows users to store and share auscultation sessions and ECG tracings.
My Dose Coach™ is a mobile app that provides T2DM patients dose recommendations for the adjustment of once-daily long-acting basal insulin based on PCP guidance.
Quell Relief is an app that connects via Bluetooth to the Quell® wearable device to help patients with chronic pain track their therapy, sleep, pain levels, and activity.
KardiaMobile records a medical-grade EKG anytime via 30 seconds of contact with sensors on the Kardia EKG device. Results are available immediately on the app.
Withings Thermo is a mobile app that syncs to the Withings Thermo, a smart temporal thermometer, and allows patients to record their temperature and add notes on relevant symptoms and medications.