FDA/CE certified apps directory
Curated by
Name
Company
Category
Apple App store
Android Play store
Website
Certification(s)
Accu-Chek Connect app
Roche Diabetes Care BV
Diabetes
Website
CE, FDA 510(k)
Accu-Chek SugarView
Roche Diabetes Care BV
Diabetes
Website
CE
Actiste
Brighter AB
Diabetes
Website
CE
Activ8rlives
Aseptika, Ltd.
Patient monitoring
Website
CE I
AgaMatrix Diabetes Manager
AgaMatrix, Inc.
Diabetes
Website
CE, FDA 510(k)
AioCare
Healthup sp. z o.o. d.b.a. Aiocare
Respiratory system
Website
CE IIa
Air Next
Nuvoair AB
Respiratory system
Website
CE IIa
AirMini
ResMed Corp.
Respiratory system
Website
FDA 510(k)
AirStrip OB
AirStrip Technologies, LLC
Patient monitoring
No website
FDA 510(k)
AirStrip ONE
AirStrip Technologies, LLC
Patient monitoring
Website
CE, FDA 510(k)
AirView
ResMed Corp.
Respiratory system, Sleep management
Website
CE IIa, FDA 510(k)
alfred: Smart care
11 Health and Technologies, Ltd.
Digestive system, Genitourinary system
Website
CE, FDA 510(k)
Altoida
altoida, Inc.
Mental Health and Behavioral Disorders, Other
Website
CE, FDA class II
Andaman7
A7 Software SA
Patient monitoring
Website
under investigation
Asthma+me
Aseptika, Ltd.
Patient monitoring
Website
CE I
aycan mobile
aycan Medical Systems, LLC
Picture Archiving and Communication System
Website
CE IIb, FDA 510(k)
Beam Dental
Beam Technologies, Inc.
Digestive system, Other, Medical Device
Website
FDA 510(k)
Beddr SleepTuner
Hancock Medical, Inc.
Sleep management
Website
FDA 510(k)
Biobeat
Biobeat Technologies, Ltd.
Patient monitoring, Blood pressure
Website
FDA 510(k), CE
BioStamp nPoint
MC10, Inc.
Patient monitoring
Website
FDA 510(k)
BlueStar Diabetes
WellDoc, Inc.
Diabetes
Website
FDA 510(k)
BreatheSmart
Cohero Health, Inc.
Respiratory system
Website
FDA 510(k)
Butterfly iQ
Butterfly Network, Inc.
Medical Device
Website
FDA 510(k)
Cancer Risk Calculator
CHU de Liège
Oncology
No website
CE I
Cankado
Cankado
Clinical trial management
Website
CE I
CANTAB Insight
Cambridge Cognition, Ltd.
Mental Health and Behavioral Disorders
Website
CE, FDA 510(k) exempt
CANTAB Mobile
Cambridge Cognition, Ltd.
Mental Health and Behavioral Disorders
Website
CE, FDA 510(k)
CareTaker
CareTaker, LLC
Heart/Circulatory System, Patient monitoring
Website
CE, FDA 510(k)
Clarify App
Clarify Medical, Inc.
Skin and subcutaneous tissue
Website
FDA 510(k)
Clarius Ultrasound App
Clarius Mobile Health Corp.
Medical Device
Website
CE, FDA 510(k)
CliniCloud
StethoCloud Pty.Ltd (CliniCloud)
Medical Device
Website
CE, FDA 510(k)
Comunicare
Comunicare Solutions nv
Chronic disease management
Website
CE I
Contour Diabetes App
Ascensia Diabetes Care Holdings, AG
Diabetes
Website
CE, FDA 510(k)
CoVa 2
toSense, Inc.
Heart/Circulatory System
Website
FDA 510(k)
Current
Current Health (formerly snap40)
Patient monitoring, Telehealth
Website
FDA class II, CE IIa
CURVE system
Fresca Medical, Inc.
Respiratory system, Sleep management
Website
FDA de novo
D-EYE
D-EYE s.r.l.
Eyes and Ears
Website
CE I, FDA 510(k) exempt
DBLG1 System
diabeloop SA
Diabetes
Website
CE
Decisio Health Patient Dashboard
Decisio Health, Inc.
Patient monitoring
Website
FDA 510(k)
Dexcom G5 Mobile
Dexcom, Inc.
Diabetes
Website
CE, FDA PMA
Dexcom G6
Dexcom, Inc.
Diabetes
Website
CE, FDA 510(k)
Diabeo
Sanofi (via Voluntis)
Diabetes
Website
CE IIb
Dip.io
Healthy.io
Genitourinary system
Website
CE, FDA 510(k)
DreaMed advisor pro
DreaMed Diabetes, Ltd.
Diabetes
Website
CE, FDA de novo
Drowzle
Resonea, Inc.
Respiratory system, Sleep management
Website
FDA 510(k)
DynoLife
DynoSense Corp.
Patient monitoring
Website
FDA 510(k)
e-vive
CyMedica Orthopedics, Inc.
Musculoskeletal system and connective Tissue
Website
FDA 510(k)
eCareCompanion
Royal Philips BV
Diabetes, Heart/Circulatory System, Endocrine, Nutritional and metabolic diseases, Teleconsult, Patient monitoring
Website
CE, FDA 510(k)
ECG App
Apple
Heart/Circulatory System
Website
FDA class II
ECG Check
Cardiac Designs, Inc.
Heart/Circulatory System
Website
CE, FDA 510(k)
Eko Stethoscope CORE/DUO
Eko Devices, Inc.
Heart/Circulatory System, Medical Device
Website
CE, FDA 510(k)
eMurmur ID
CSD Labs International Inc. d.b.a. eMurmur
Heart/Circulatory System
Website
CE, FDA 510(k)
Epihunter
epihunter nv
Epilepsy
Website
CE I
EQ Active Brain Tracking
HighMark Interactive, Inc.
Nervous system
Website
CE, FDA 510(k)
Eversense CGM
Senseonics, Inc.
Diabetes
Website
CE, FDA PMA
Eye-Sync
SyncThink, Inc.
Eyes and Ears
Website
FDA 510(k)
EyeQue PVT
EyeQue Corp.
Eyes and Ears
Website
CE, FDA 510(k) exempt
Fever Scout
VivaLnk, Inc.
Medical Device
Website
FDA 510(k)
FibriCheck
Qompium nv
Heart/Circulatory System
Website
CE IIa, FDA 510(k)
Flow
Flow Neuroscience AB
Mental Health and Behavioral Disorders
Website
CE IIa
FreeStyle LibreLink
Abbott Diabetes Care
Diabetes
Website
CE IIb
Genesis Touch
Resideo Technologies, Inc. (Honeywell spin-off)
Teleconsult, Patient monitoring
Website
FDA 510(k)
Global ECG Management System (GEMS)
CardioComm Solutions, Inc.
Heart/Circulatory System, Patient monitoring
Website
CE, FDA 510(k)
Glooko - Track diabetes data
Glooko, Inc.
Diabetes
Website
CE, FDA 510(k)
GlucoMe
GlucoMe, Inc.
Diabetes
Website
CE
Gmate ON
philosys Co. Ltd.
Diabetes
Website
CE
Gmate SMART
philosys Co. Ltd.
Diabetes
Website
CE, FDA 510(k)
Go Dose
Eli Lilly and Company
Diabetes
No website
FDA 510(k)
GoCheck Kids+
Gobiquity, Inc.
Eyes and Ears
Website
CE, FDA 510(k) exempt
GoSpiro
Monitored Therapeutics, Inc.
Respiratory system
Website
CE, FDA 510(k)
Guardian connect
Medtronic, Inc.
Diabetes
Website
CE, FDA PMA
Hailie
Adherium, Ltd.
Respiratory system
Website
CE, FDA 510(k)
Health Mate
CE Class I
Heart/Circulatory System, Other
Website
CE, FDA class I
Health2Sync
H2, Inc.
Diabetes
Website
FDA 510(k)
Heraeus Care
Heraeus Holding GmbH
Patient monitoring
Website
CE I
Hygieia D-Nav
Hygieia, Inc.
Diabetes
Website
FDA 510(k)
ID-Cap
etectRx, Inc.
Drug delivery
Website
FDA 510(k)
IDEAL LIFE Health App
Ideal Life, Inc.
Teleconsult, Patient monitoring
Website
FDA class I
iExaminer Pro
Welch Allyn, Inc.
Eyes and Ears
Website
CE, FDA 510(k)
iHealth Gluco-Smart
iHealthLabs, Inc.
Diabetes
Website
CE Ia, FDA 510(k)
iHealth MyVitals
iHealthLabs, Inc.
Heart/Circulatory System, Endocrine, Nutritional and metabolic diseases, Other, Medical Device
Website
CE Ia, FDA 510(k)
InPen: Diabetes Management App
Companion Medical, Inc.
Diabetes
Website
CE, FDA 510(k)
Insulia
Voluntis SA
Diabetes
Website
CE IIb, FDA 510(k)
IntelliSpace Portal Platform
Royal Philips BV
Picture Archiving and Communication System
Website
CE, FDA 510(k)
InTouch Health
InTouch Technologies, Inc.
Teleconsult, Patient monitoring
Website
FDA 510(k)
inui
inui Health (formerly Scanadu)
Genitourinary system
Website
CE, FDA 510(k)
InvisionECG system
InvisionHeart, Inc.
Heart/Circulatory System
Website
FDA 510(k)
iSage Rx
Amalgam Rx, Inc.
Diabetes
Website
FDA 510(k)
Jacoti ListenApp
Jacoti bvba
Eyes and Ears
Website
CE IIa, FDA class I
JiveX
VISUS Health IT GmbH
Picture Archiving and Communication System
Website
CE, FDA 510(k)
Kaia
Kaia Health Software GmbH
Pain management
Website
CE I
Kardia
AliveCor, Inc.
Heart/Circulatory System
Website
CE, FDA 510(k)
Kinsa Smart Thermometer
Kinsa, Inc.
Medical Device
Website
FDA 510(k)
Learn2ACT
Learn2ACT VoF
Mental Health and Behavioral Disorders
Website
under investigation
Lincus Companion
Rescon Technologies, Ltd.
Patient monitoring
Website
CE I
Livongo
Livongo Health, Inc.
Diabetes
Website
FDA 510(k)
Masimo Professional or Personal Health
Masimo Corp.
Heart/Circulatory System, Respiratory system
Website
CE, FDA 510(k)
Master Caution
HealthWatch Technologies, Ltd.
Heart/Circulatory System, Respiratory system, Patient monitoring
Website
CE, FDA 510(k)
Mate and Alert App for Embrace Watch
Empatica, Inc.
Nervous System, Other, Patient monitoring
Website
FDA 510(k)
McKesson ECG Mobile
McKesson Corp.
Heart/Circulatory System
Website
FDA 510(k)
MedDream DICOM Viewer
Softneta UAB
Picture Archiving and Communication System
Website
CE IIa, FDA 510(k)
Microlife Connected Health
Microlife Corp.
Heart/Circulatory System
Website
CE, FDA 510(k)
MiniMed Connect
Medtronic, Inc.
Diabetes
Website
CE, FDA 510(k)
Mobile MIM
MIM Software, Inc.
Picture Archiving and Communication System
Website
FDA 510(k)
MoMe Kardia
InfoBionic, Inc.
Heart/Circulatory System
Website
CE, FDA 510(k)
MoovCare Lung
Sivan Innovation, Ltd.
Patient monitoring
Website
CE I
moveUP
moveUP cvba
Musculoskeletal system and connective Tissue
Website
CE I
My Dose Coach
Sanofi SA
Diabetes
Website
FDA 510(k)
MyDario
Dario Health Corp.
Diabetes
Website
CE, FDA 510(k)
myMerlin for Confirm Rx ICM
Abbott (formerly St. Jude Medical)
Heart/Circulatory System
Website
CE, FDA 510(k)
mySinusitisCoach
EUropean FOrum for Research and Education in Allergy and airway Diseases (Galenus Health)
Respiratory system
Website
CE
mySugr
mySugr GmbH (acquired by Roche in 2017)
Diabetes
Website
CE IIb, FDA class I
myVisionTrack (mVT)
Vital Art and Science, LLC
Eyes and Ears
Website
CE, FDA 510(k)
Natural Cycles
NaturalCycles Nordic AB
Birth control / contraception
Website
FDA 510(k), CE IIa
Naya Health Tracker
Naya Health, Inc.
Patient monitoring
Website
FDA 510(k)
Nerivio Migra
Theranica Bio-Electronics Ltd.
Migraine electroceutical
Website
FDA De Novo
nfant feeding solution
NFANT Labs, LLC
Infant feeding
Website
FDA 510(k)
NightOwl Companion
Ectosense nv
Respiratory system, Sleep management
Website
CE IIa
Noona
Varian Medical Systems, Inc.
Oncology
Website
CE IIb
Nucleus Smart
Cochlear, Ltd.
Eyes and Ears
Website
CE, FDA PMA
Oleena
Voluntis SA
Oncology
Website
FDA 510(k)
Omnipod DISPLAY & Omnipod VIEW
Insulet Corp.
Diabetes
Website
FDA 510(k)
ONCOAssist
Portable Medical Technology, Ltd.
Oncology
Website
CE I
One Drop I Mobile
Informed Data Systems, Inc. and One Drop
Diabetes
Website
CE, FDA 510(k)
Opternative
Visibly (formerly Opternative)
Eyes and Ears
Website
FDA class I
Optum TeleHealth
Optum, Inc.
Teleconsult, Patient monitoring
Website
FDA 510(k)
PACSonWEB
Dobco Medical Systems nv
Picture Archiving and Communication System
Website
CE IIa
painKARE
TrioWave Technologies, Inc.
Pain management
Website
FDA 510(k)
Patient controller
Abbott (formerly St. Jude Medical)
Pain management
Website
FDA PMA
PatientCare
Preventice, Inc.
Heart/Circulatory System
Website
CE, FDA 510(k)
Pear reSET
Pear Therapeutics, Inc.
Mental Health and Behavioral Disorders, Other
Website
FDA de novo
Pear reSET-O
Pear Therapeutics, Inc.
Mental Health and Behavioral Disorders, Other
No website
FDA 510(k)
Pearl Fertility App
Colorimetrix, Inc.
Fertility
Website
CE
Peerbridge Cor
Peerbridge Health, Inc.
Heart/Circulatory System
Website
FDA 510(k)
PeriCoach
Analytica, Ltd.
Musculoskeletal system and connective Tissue, Genitourinary system
Website
CE, FDA 510(k)
Philips IntelliVue Mobile Caregiver
Royal Philips BV
Patient monitoring
Website
CE, FDA 510(k)
Philips Lumify Ultrasound App
Royal Philips BV
Medical Device
Website
CE IIa, FDA 510(k)
Physiotrace Smart
NimbleHearth, Inc.
Heart/Circulatory System
Website
FDA 510(k)
PhysioWave Pro
PhysioWave, Inc.
Heart/Circulatory System
Website
FDA 510(k)
pillphone
ImageWareSystem, Inc.
Patient monitoring
Website
FDA 510(k)
Pivot Journey
Carrot, Inc.
Respiratory system, Other
Website
FDA 510(k)
POPS! Diabetes care
POPS! Diabetes Care, Inc.
Diabetes
Website
FDA 510(k)
Powerdot
Smartmissimo Technologies PTE, Ltd.
Musculoskeletal system and connective Tissue
Website
CE, FDA 510(k)
Prescription Check
JAND, Inc. d.b.a. Warby Parker
Eyes and Ears
Website
FDA class I
ProAir Digihaler
Teva Pharmaceutical Industries, Ltd.
Respiratory system
Website
FDA 510(k)
Propeller Health
Reciprocal Labs Corp.
Respiratory system
Website
CE, FDA 510(k)
Proteus Discover
Proteus Digital Health, Inc.
Drug delivery
Website
FDA 510(k)
Qardio heart health
Qardio, Inc.
Heart/Circulatory System, Patient monitoring
Website
CE, FDA 510(k)
Quell Relief
NeuroMetrix, Inc.
Pain management
Website
CE, FDA 510(k)
RemeCoach
Remedus bvba
Patient monitoring
Website
CE IIa
ResAppDx-EU
ResApp Health, Ltd.
Respiratory system, Sleep management
Website
CE IIa
ResolutionMD
PureWeb (formerly Calgary Scientific, Inc.)
Picture Archiving and Communication System
Website
CE, FDA 510(k)
RhythmAnalytics
Biofourmis, Inc.
Heart/Circulatory System
Website
FDA class II
Rooti Rx
Rooti Labs, Ltd.
Heart/Circulatory System
Website
FDA 510(k)
Routine
Routine Health GmbH
Rehabilitation, pain management
Website
CE I
Samsung Health
Samsung Electronics Co, Ltd.
Heart/Circulatory System, Endocrine, Nutritional and metabolic diseases, Other
Website
FDA 510(k)
Scanwell
Scanwell Health, Inc.
Genitourinary system
Website
FDA 510(k)
Sense4baby
AirStrip Technologies, LCC (formerly Sense4Baby, Inc.)
Genitourinary system, Other, Patient monitoring
Website
CE, FDA 510(k)
SilverCloud
Silvercloud Health, Inc.
Mental Health and Behavioral Disorders
Website
under investigation
SimplECG
Nanowear
Heart/Circulatory System, Respiratory system
Website
FDA 510(k)
SkinVision
SkinVision BV
Oncology, Dermatology / skin
Website
CE I
SmartClick eGlycemic Management System
Aseko, Inc. d.b.a. Glytec, LLC
Diabetes
Website
FDA 510(k)
Smartheart
Shl Telemedicine, Ltd.
Heart/Circulatory System
Website
CE, FDA 510(k)
SONON Ultrasound
Healcerion, Inc.
Medical Device
Website
CE, FDA 510(k)
SOZOapp
ImpediMed, Inc.
Genitourinary system
Website
FDA 510(k)
StethoMe
StethoMe sp. z o.o.
Heart/Circulatory System, Medical Device
Website
CE I
SugarBEAT
Nemaura Medical, Inc.
Diabetes
Website
CE I
Sway Medical
Sway Operations, LLC
Nervous System
Website
CE, FDA 510(k)
Syndo Health
Syndo Health nv
Heart/Circulatory System
Website
CE I
Temp Sitter
Guangdong Biolight Meditech Co, Ltd.
Medical Device, Patient monitoring
Website
FDA 510(k)
TempTraq
Blue Spark Technologies, Inc.
Medical Device, Patient monitoring
Website
FDA 510(k)
The Levo System
Otoharmonics Corp.
Eyes and Ears
Website
CE, FDA 510(k)
The Vista Solution
VitalConnect, Inc.
Patient monitoring
Website
CE, FDA 510(k)
Trak: Sperm Health & Fertility
Sandstone Diagnostics, Inc.
Genitourinary system, Other
Website
FDA 510(k)
TraumaCad Mobile
Brainlab, Ltd. (Voyant Health)
Musculoskeletal system and connective Tissue
Website
FDA 510(k)
TrialMax App
CRF Health (now Signant Health)
Patient monitoring
Website
CE, FDA class I
Triton Sponge, Canister, L&D
Gauss Surgical, Inc.
Blood loss monitor
Website
FDA 510(k)
TytoCare (TytoApp)
Tyto Care, Ltd.
Teleconsult, Patient monitoring
Website
CE, FDA 510(k)
Verily Study Watch
Verily (Google Alphabet)
Heart/Circulatory System
Website
FDA 510(k)
Vital Sync Virtual Patient Monitoring Platform 2.6
Medtronic, Inc.
Patient monitoring
Website
FDA 510(k)
Viz.ai
Viz.ai, Inc.
Heart/Circulatory System, Other
Website
CE, FDA 510(k)
Vue Motion
Philips Healthcare Information Solutions (formerly Carestream Health, Inc.)
Picture Archiving and Communication System
Website
FDA 510(k)
Vyntus WALK
Vyaire Medical, Inc.
Respiratory system
Website
CE, FDA 510(k)
Well@Home
BeWell Innovations nv
Pain management
Website
CE Class I
Wing
Sparo, Inc.
Respiratory system
Website
FDA 510(k)
your leva
Renovia, Inc.
Musculoskeletal system and connective Tissue, Genitourinary system
Website
FDA 510(k)
CapMedic
Cognita Labs, LLC
Respiratory system
Website
FDA 510(k)
CADence IRONMAN
AUM Cardiovascular, Inc.
Heart/Circulatory System
Website
FDA 510(k)
Medicus AI
Medicus AI, gmbH
Self management
Website
CE Class I
One Touch Reveal
Lifescan, inc.
Diabetes
Website
CE, FDA 510(k)
LifeSignals
LifeSignals
Heart/Circulatory System
Website
CE Class I
Keesense
Chronolife
Heart/Circulatory System, Respiratory system
Website
CE Class II
WatchPAT™ ONE
Itamar Medical
Sleep management, Sleep apneu
Website
CE Class I
Somryst
Pear Therapeutics, Inc.
Sleep management, Insomnia
Website
FDA Pre-Cert
Lumee
Profusa
Real-time monitoring of tissue oxygen
Website
CE Class I
Luscii
Luscii healthtech
Teleconsult, Patient monitoring
Website
CE Class I
EndeavorRx
Akili
ADHD, mental health
Website
FDA 510(k)
Sunrise
Sunrise
Sleep, sleepapneu
Website
CE Class I
Healthentia
Healthentia
Self reporting RWD
Website
CE Class I
MyMerlinPulse
Abbott (formerly St. Jude Medical)
Heart/Circulatory System
No website
CE, FDA 510(k)
C100 system
Circadia Health
Respiratory system
Website
FDA 510(k)
Vida24
Vidavo
Teleconsult, Patient monitoring
Website
CE Class IIa
Patient Controller App - NeuroSphere Digital Care
Abbott
Neuromodulation, pain, movement disorders
Website
FDA 510(k)
Vitls
Vitls
Medical Device, Patient monitoring
Website
FDA 510(k)
Samsung Health ECG monitor
Samsung Electronics Co, Ltd.
Heart/Circulatory System
Website
FDA Class II
ScanWatch
Withings France SA (formerly Nokia)
Heart/Circulatory System, Respiratory, Sleep, Oxygen
Website
CE class I
Fitbit Sense ECG App
Fitbit
Heart/Circulatory System
Website
CE, FDA 510(k)
SimpleSense
Nanowear
Heart, lungs, and upper vascular system
Website
FDA Class II 510(k)
Nightware
Nightware
Nightmares related to PTSD
Website
TempPal
IweeCare
Temperature Thermometer patch
Website
CE class I
VitalMed VitalCompanion diary app
AireHealth
Respiratory system/ Wheez
Website
FDA Class II medical device
Strados RESP
Strados
Respiratory system/ lung sounds
Website
FDA Class II medical device
Neuronaute EEG system
BioSerenity
Epilepsy
Website
FDA 510(k)
Aktiia
Aktiia
Continuous Blood pressure monitoring
Website
CE Class lla
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