FDA/CE certified apps directory
Curated by 
Name
Company
Category
Apple App store
Android Play store
Website
Certification(s)
AirStrip OB
AirStrip Technologies, LLC
Patient monitoring
No website
FDA 510(k)
alfred: Smart care
11 Health and Technologies, Ltd.
Digestive system, Genitourinary system
CE, FDA 510(k)
aycan mobile
aycan Medical Systems, LLC
Picture Archiving and Communication System
CE IIb, FDA 510(k)
Cancer Risk Calculator
CHU de Liège
Oncology
No website
CE I
CANTAB Insight
Cambridge Cognition, Ltd.
Mental Health and Behavioral Disorders
CE, FDA 510(k) exempt
eCareCompanion
Royal Philips BV
Diabetes, Heart/Circulatory System, Endocrine, Nutritional and metabolic diseases, Teleconsult, Patient monitoring
CE, FDA 510(k)
Eko Stethoscope CORE/DUO
Eko Devices, Inc.
Heart/Circulatory System, Medical Device
CE, FDA 510(k)
Genesis Touch
Resideo Technologies, Inc. (Honeywell spin-off)
Teleconsult, Patient monitoring
FDA 510(k)
Global ECG Management System (GEMS)
CardioComm Solutions, Inc.
Heart/Circulatory System, Patient monitoring
CE, FDA 510(k)
Go Dose
Eli Lilly and Company
Diabetes
No website
FDA 510(k)
iHealth MyVitals
iHealthLabs, Inc.
Heart/Circulatory System, Endocrine, Nutritional and metabolic diseases, Other, Medical Device
CE Ia, FDA 510(k)
IntelliSpace Portal Platform
Royal Philips BV
Picture Archiving and Communication System
CE, FDA 510(k)
Masimo Professional or Personal Health
Masimo Corp.
Heart/Circulatory System, Respiratory system
CE, FDA 510(k)
Master Caution
HealthWatch Technologies, Ltd.
Heart/Circulatory System, Respiratory system, Patient monitoring
CE, FDA 510(k)
Mate and Alert App for Embrace Watch
Empatica, Inc.
Nervous System, Patient monitoring, Covid-19 (Corona)
CE IIa, FDA 510(k)
MedDream DICOM Viewer
Softneta UAB
Picture Archiving and Communication System
CE IIa, FDA 510(k)
myMerlin for Confirm Rx ICM
Abbott (formerly St. Jude Medical)
Heart/Circulatory System
CE, FDA 510(k)
mySinusitisCoach
EUropean FOrum for Research and Education in Allergy and airway Diseases (Galenus Health)
Respiratory system
CE
Pear reSET-O
Pear Therapeutics, Inc.
Mental Health and Behavioral Disorders, Other
No website
FDA 510(k)
PeriCoach
Analytica, Ltd.
Musculoskeletal system and connective Tissue, Genitourinary system
CE, FDA 510(k)
Powerdot
Smartmissimo Technologies PTE, Ltd.
Musculoskeletal system and connective Tissue
CE, FDA 510(k)
ResolutionMD
PureWeb (formerly Calgary Scientific, Inc.)
Picture Archiving and Communication System
CE, FDA 510(k)
Samsung Health
Samsung Electronics Co, Ltd.
Heart/Circulatory System, Endocrine, Nutritional and metabolic diseases, Other
FDA 510(k)
Sense4baby
AirStrip Technologies, LCC (formerly Sense4Baby, Inc.)
Genitourinary system, Other, Patient monitoring
CE, FDA 510(k)
Trak: Sperm Health & Fertility
Sandstone Diagnostics, Inc.
Genitourinary system, Other
FDA 510(k)
TraumaCad Mobile
Brainlab, Ltd. (Voyant Health)
Musculoskeletal system and connective Tissue
FDA 510(k)
Vital Sync Virtual Patient Monitoring Platform 2.6
Medtronic, Inc.
Patient monitoring
FDA 510(k)
Vue Motion
Philips Healthcare Information Solutions (formerly Carestream Health, Inc.)
Picture Archiving and Communication System
FDA 510(k)
your leva
Renovia, Inc.
Musculoskeletal system and connective Tissue, Genitourinary system
FDA 510(k)
MyMerlinPulse
Abbott (formerly St. Jude Medical)
Heart/Circulatory System
No website
CE, FDA 510(k)
Patient Controller App - NeuroSphere Digital Care
Abbott
Neuromodulation, pain, movement disorders
FDA 510(k)
ScanWatch
Withings France SA (formerly Nokia)
Heart/Circulatory System, Respiratory, Sleep, Oxygen
CE class I
VitalMed VitalCompanion diary app
AireHealth
Respiratory system/ Wheez
FDA Class II medical device
Cardiacsense
Cardiacsense
Heart (AFib), lungs, and upper vascular system, oxygen saturation
CE class I
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