FDA/CE certified apps directory

Curated by

Name
Company
Category
Apple App store
Android Play store
Website
Certification(s)
HealthLook
AXA Assistance nv
Patient monitoring
App store button
Play store button
CE
Actiste (demo app)
Brighter AB
Diabetes
App store button
Play store button
CE
DBLG1 System
diabeloop SA
Diabetes
CE
mySinusitisCoach
EUropean FOrum for Research and Education in Allergy and airway Diseases (Galenus Health)
Respiratory system
App store button
Play store button
CE
GlucoMe
GlucoMe, Inc.
Diabetes
App store button
Play store button
CE
Gmate ON
philosys Co. Ltd.
Diabetes
Play store button
CE
Activ8rlives
Aseptika, Ltd.
Patient monitoring
App store button
Play store button
CE I
Asthma+me
Aseptika, Ltd.
Patient monitoring
App store button
Play store button
CE I
Well@Home
BeWell Innovations nv
Pain management
App store button
Play store button
CE I
Cankado
Cankado
Clinical trial management
App store button
Play store button
CE I
Cancer Risk Calculator
CHU de Li├Ęge
Oncology
App store button
Play store button
No website
CE I
Comunicare
Comunicare Solutions nv
Chronic disease management
App store button
Play store button
CE I
Epihunter
epihunter nv
Epilepsy
App store button
Play store button
CE I
Heraeus Care
Heraeus Holding GmbH
Patient monitoring
App store button
Play store button
CE I
Kaia
Kaia Health Software GmbH
Pain management
App store button
Play store button
CE I
moveUP
moveUP cvba
Musculoskeletal system and connective Tissue
App store button
CE I
SugarBEAT
Nemaura Medical, Inc.
Diabetes
CE I
ONCOAssist
Portable Medical Technology, Ltd.
Oncology
App store button
Play store button
CE I
Lincus Companion
Rescon Technologies, Ltd.
Patient monitoring
App store button
Play store button
CE I
Routine
Routine Health GmbH
Rehabilitation, pain management
App store button
CE I
SilverCloud
Silvercloud Health, Inc.
Mental health
App store button
Play store button
CE I
MoovCare Lung
Sivan Innovation, Ltd.
Patient monitoring
CE I
SkinVision
SkinVision BV
Oncology, Dermatology / skin
App store button
Play store button
CE I
StethoMe
StethoMe sp. z o.o.
Heart/Circulatory System, Medical Device
Play store button
CE I
Syndo Health
Syndo Health nv
Cardiology
App store button
Play store button
CE I
D-EYE
D-EYE s.r.l.
Eyes and Ears
App store button
CE I, 510(k) exempt
iHealth Gluco-Smart
iHealthLabs, Inc.
Diabetes
App store button
Play store button
CE Ia, FDA 510(k)
iHealth MyVitals
iHealthLabs, Inc.
Heart/Circulatory System, Endocrine, Nutritional and metabolic diseases, Other, Medical Device
App store button
Play store button
CE Ia, FDA 510(k)
PACSonWEB
Dobco Medical Systems nv
Picture Archiving and Communication System
App store button
Play store button
CE IIa
NightOwl Companion
Ectosense nv
Respiratory system, Sleep
App store button
Play store button
CE IIa
Flow
Flow Neuroscience AB
Mental health
App store button
CE IIa
AioCare
Healthup sp. z o.o. d.b.a. Aiocare
Respiratory system
App store button
Play store button
CE IIa
Air Next
Nuvoair AB
Respiratory system
App store button
Play store button
CE IIa
RemeCoach
Remedus bvba
Patient monitoring
App store button
Play store button
CE IIa
ResAppDx-EU
ResApp Health, Ltd.
Respiratory system, Sleep
CE IIa
AirView
ResMed Corp.
Sleep management
CE IIa
FibriCheck
Qompium nv
Heart/Circulatory System
App store button
Play store button
CE IIa, FDA 510(k)
MedDream DICOM Viewer
Softneta UAB
Picture Archiving and Communication System
CE IIa, FDA 510(k)
E4 realtime
Empatica, Inc.
Patient monitoring
App store button
Play store button
CE IIa, FDA Class I
Jacoti ListenApp
Jacoti bvba
Eyes and Ears
App store button
CE IIa, FDA class I
FreeStyle LibreLink
Abbott Diabetes Care
Diabetes
App store button
Play store button
CE IIb
Diabeo
Sanofi (via Voluntis)
Diabetes
App store button
Play store button
CE IIb
Noona
Varian Medical Systems, Inc.
Oncology
App store button
Play store button
CE IIb
aycan mobile
aycan Medical Systems, LLC
Picture Archiving and Communication System
App store button
CE IIb, FDA 510(k)
Insulia
Voluntis SA
Diabetes
App store button
Play store button
CE IIb, FDA 510(k)
mySugr
mySugr GmbH (acquired by Roche in 2017)
Diabetes
App store button
Play store button
CE IIb, FDA class I
EyeQue PVT
EyeQue Corp.
Eyes and Ears
App store button
Play store button
CE, Class I 510(k) exempt
GoCheck Kids+
Gobiquity, Inc.
Eyes and Ears
App store button
CE, Class II 510(k) exempt
alfred: Smart care
11 Health and Technologies, Ltd.
Digestive system, Genitourinary system
App store button
Play store button
CE, FDA 510(k)
myMerlin for Confirm Rx ICM
Abbott (formerly St. Jude Medical)
Heart/Circulatory System
App store button
Play store button
CE, FDA 510(k)
Hailie
Adherium, Ltd.
Respiratory system
App store button
Play store button
CE, FDA 510(k)
Sense4baby
AirStrip Technologies, LCC (formerly Sense4Baby, Inc.)
Genitourinary system, Other, Patient monitoring
App store button
Play store button
CE, FDA 510(k)
AirStrip ONE
AirStrip Technologies, LLC
Patient monitoring
App store button
Play store button
CE, FDA 510(k)
Kardia
AliveCor, Inc.
Heart/Circulatory System
App store button
Play store button
CE, FDA 510(k)
PeriCoach
Analytica, Ltd.
Musculoskeletal system and connective Tissue, Genitourinary system
App store button
Play store button
CE, FDA 510(k)
Contour Diabetes App
Ascensia Diabetes Care Holdings, AG
Diabetes
App store button
Play store button
CE, FDA 510(k)
CANTAB Mobile
Cambridge Cognition, Ltd.
Mental Health and Behavioral Disorders
App store button
CE, FDA 510(k)
ECG Check
Cardiac Designs, Inc.
Heart/Circulatory System
App store button
Play store button
CE, FDA 510(k)
Global ECG Management System (GEMS)
CardioComm Solutions, Inc.
Heart/Circulatory System, Patient monitoring
App store button
Play store button
CE, FDA 510(k)
CareTaker
CareTaker, LLC
Heart/Circulatory System, Patient monitoring
CE, FDA 510(k)
Clarius Ultrasound App
Clarius Mobile Health Corp.
Medical Device
App store button
Play store button
CE, FDA 510(k)
InPen: Diabetes Management App
Companion Medical, Inc.
Diabetes
App store button
Play store button
CE, FDA 510(k)
eMurmur ID
CSD Labs International Inc. d.b.a. eMurmur
Heart/Circulatory System
CE, FDA 510(k)
Dexcom G6
Dexcom, Inc.
Diabetes
App store button
Play store button
CE, FDA 510(k)
Eko Stethoscope CORE/DUO
Eko Devices, Inc.
Heart/Circulatory System, Medical Device
App store button
Play store button
CE, FDA 510(k)
Glooko - Track diabetes data
Glooko, Inc.
Diabetes
App store button
Play store button
CE, FDA 510(k)
SONON Ultrasound
Healcerion, Inc.
Medical Device
App store button
Play store button
CE, FDA 510(k)
Master Caution
HealthWatch Technologies, Ltd.
Heart/Circulatory System, Respiratory system, Patient monitoring
Play store button
CE, FDA 510(k)
Dip.io
Healthy.io
Genitourinary system
App store button
Play store button
CE, FDA 510(k)
EQ Active Brain Tracking
HighMark Interactive, Inc.
Nervous system
App store button
Play store button
CE, FDA 510(k)
MoMe Kardia
InfoBionic, Inc.
Heart/Circulatory System
Play store button
CE, FDA 510(k)
One Drop I Mobile
Informed Data Systems, Inc. and One Drop
Diabetes
App store button
Play store button
CE, FDA 510(k)
inui
inui Health (formerly Scanadu)
Genitourinary system
App store button
Play store button
CE, FDA 510(k)
Dario
Labstyle Innovation, Ltd.
Diabetes
App store button
Play store button
CE, FDA 510(k)
Masimo Professional or Personal Health
Masimo Corp.
Heart/Circulatory System, Respiratory system
App store button
Play store button
CE, FDA 510(k)
MiniMed Connect
Medtronic, Inc.
Diabetes
App store button
Play store button
CE, FDA 510(k)
Microlife Connected Health
Microlife Corp.
Heart/Circulatory System
App store button
Play store button
CE, FDA 510(k)
GoSpiro
Monitored Therapeutics, Inc.
Respiratory system
App store button
Play store button
CE, FDA 510(k)
Quell Relief
NeuroMetrix, Inc.
Pain management
App store button
Play store button
CE, FDA 510(k)
The Levo System
Otoharmonics Corp.
Eyes and Ears
App store button
CE, FDA 510(k)
Gmate SMART
philosys Co. Ltd.
Diabetes
App store button
Play store button
CE, FDA 510(k)
PatientCare
Preventice, Inc.
Heart/Circulatory System
CE, FDA 510(k)
ResolutionMD
PureWeb (formerly Calgary Scientific, Inc.)
Picture Archiving and Communication System
CE, FDA 510(k)
Qardio heart health
Qardio, Inc.
Heart/Circulatory System, Patient monitoring
App store button
Play store button
CE, FDA 510(k)
Propeller Health
Reciprocal Labs Corp.
Respiratory system
App store button
Play store button
CE, FDA 510(k)
Accu-Chek Connect app
Roche Diabetes Care BV
Diabetes
App store button
Play store button
CE, FDA 510(k)
eCareCompanion
Royal Philips BV
Diabetes, Heart/Circulatory System, Endocrine, Nutritional and metabolic diseases, Teleconsult, Patient monitoring
CE, FDA 510(k)
IntelliSpace Portal Platform
Royal Philips BV
Picture Archiving and Communication System
CE, FDA 510(k)
Philips Lumify Ultrasound App
Royal Philips BV
Medical Device
Play store button
CE, FDA 510(k)
Philips IntelliVue Mobile Caregiver
Royal Philips BV
Patient monitoring
App store button
Play store button
CE, FDA 510(k)
Smartheart
Shl Telemedicine, Ltd.
Heart/Circulatory System
App store button
Play store button
CE, FDA 510(k)
Powerdot
Smartmissimo Technologies PTE, Ltd.
Musculoskeletal system and connective Tissue
App store button
Play store button
CE, FDA 510(k)
CliniCloud
StethoCloud Pty.Ltd (CliniCloud)
Medical Device
App store button
Play store button
CE, FDA 510(k)
Sway Medical
Sway Operations, LLC
Nervous System
App store button
CE, FDA 510(k)
TytoCare (TytoApp)
Tyto Care, Ltd.
Teleconsult
App store button
Play store button
CE, FDA 510(k)
JiveX
VISUS Health IT GmbH
Picture Archiving and Communication System
CE, FDA 510(k)
myVisionTrack (mVT)
Vital Art and Science, LLC
Eyes and Ears
App store button
Play store button
CE, FDA 510(k)
The Vista Solution
VitalConnect, Inc.
Patient monitoring
CE, FDA 510(k)
Viz.ai
Viz.ai, Inc.
Heart/Circulatory System, Other
App store button
Play store button
CE, FDA 510(k)
Vyntus WALK
Vyaire Medical, Inc.
Respiratory system
CE, FDA 510(k)
iExaminer Pro
Welch Allyn, Inc.
Eyes and Ears
App store button
CE, FDA 510(k)
TrialMax App
CRF Health (now Signant Health)
Patient monitoring
App store button
Play store button
CE, FDA class I
Health Mate
Withings France SA (formerly Nokia)
Heart/Circulatory System, Other
App store button
Play store button
CE, FDA class I
Altoida
altoida, Inc.
Mental Health and Behavioral Disorders, Other
CE, FDA class II
DreaMed advisor pro
DreaMed Diabetes, Ltd.
Diabetes
App store button
CE, FDA de novo
CANTAB Insight
Cambridge Cognition, Ltd.
Mental Health and Behavioral Disorders
App store button
CE, FDA exempt
Nucleus Smart
Cochlear, Ltd.
Eyes and Ears
App store button
Play store button
CE, FDA PMA
Dexcom G5 Mobile
Dexcom, Inc.
Diabetes
App store button
Play store button
CE, FDA PMA
Guardian connect
Medtronic, Inc.
Diabetes
App store button
Play store button
CE, FDA PMA
Eversense CGM system
Senseonics Holdings, Inc.
Diabetes
App store button
Play store button
CE, FDA PMA
Eversense CGM
Senseonics, Inc.
Diabetes
App store button
Play store button
CE, FDA PMA
AgaMatrix Diabetes Manager
AgaMatrix Holdings, LLC
Diabetes
App store button
Play store button
CE, FDA 510(k)
AirStrip OB
AirStrip Technologies, LLC
Patient monitoring
App store button
Play store button
FDA 510(k)
KardiaAI
AliveCor, Inc.
Heart/Circulatory System
App store button
Play store button
FDA 510(k)
iSage Rx
Amalgam Rx, Inc.
Diabetes
App store button
Play store button
FDA 510(k)
SmartClick eGlycemic Management System
Aseko, Inc. d.b.a. Glytec, LLC
Diabetes
FDA 510(k)
Beam Dental
Beam Technologies, Inc.
Digestive system, Other, Medical Device
App store button
Play store button
FDA 510(k)
Biobeat
Biobeat Technologies, Ltd.
Patient monitoring, Blood pressure
App store button
Play store button
FDA 510(k)
TempTraq
Blue Spark Technologies, Inc.
Medical Device, Patient monitoring
App store button
Play store button
FDA 510(k)
TraumaCad Mobile
Brainlab, Ltd. (Voyant Health)
Musculoskeletal system and connective Tissue
App store button
FDA 510(k)
Butterfly iQ
Butterfly Network, Inc.
Medical Device
App store button
FDA 510(k)
Pivot Journey
Carrot, Inc.
Respiratory system, Other
App store button
Play store button
FDA 510(k)
Clarify App
Clarify Medical, Inc.
Skin and subcutaneous tissue
App store button
Play store button
FDA 510(k)
BreatheSmart
Cohero Health, Inc.
Respiratory system
App store button
Play store button
FDA 510(k)
e-vive
CyMedica Orthopedics, Inc.
Musculoskeletal system and connective Tissue
App store button
Play store button
FDA 510(k)
Decisio Health Patient Dashboard
Decisio Health, Inc.
Patient monitoring
FDA 510(k)
DynoLife
DynoSense Corp.
Patient monitoring
App store button
Play store button
FDA 510(k)
Go Dose
Eli Lilly and Company
Diabetes
App store button
Play store button
FDA 510(k)
Alert App for Embrace Watch
Empatica, Inc.
Nervous System, Other, Patient monitoring
App store button
Play store button
FDA 510(k)
Mate and Alert for Embrace Watch
Empatica, Inc.
Nervous System, Other
App store button
Play store button
FDA 510(k)
Triton Sponge, Canister, L&D
Gauss Surgical, Inc.
Blood loss monitor
App store button
FDA 510(k)
Temp Sitter
Guangdong Biolight Meditech Co, Ltd.
Medical Device, Patient monitoring
App store button
Play store button
FDA 510(k)
Health2Sync
H2, Inc.
Diabetes
App store button
Play store button
FDA 510(k)
Beddr SleepTuner
Hancock Medical, Inc.
Sleep management
App store button
FDA 510(k)
Hygieia D-Nav
Hygieia, Inc.
Diabetes (Insulin management)
App store button
Play store button
FDA 510(k)
pillphone
ImageWareSystem, Inc.
Patient monitoring
App store button
Play store button
FDA 510(k)
Omnipod DISPLAY & Omnipod VIEW
Insulet Corp.
Diabetes
App store button
FDA 510(k)
InTouch Health
InTouch Technologies, Inc.
Teleconsult, Patient monitoring
App store button
FDA 510(k)
InvisionECG system
InvisionHeart, Inc.
Heart/Circulatory System
FDA 510(k)
Kinsa Smart Thermometer
Kinsa, Inc.
Medical Device
App store button
Play store button
FDA 510(k)
Livongo
Livongo Health, Inc.
Diabetes
App store button
Play store button
FDA 510(k)
BioStamp nPoint
MC10, Inc.
Patient monitoring
FDA 510(k)
McKesson ECG Mobile
McKesson Corp.
Heart/Circulatory System
App store button
FDA 510(k)
Guardian Connect + Sugar.IQ
Medtronic, Inc.
Diabetes
App store button
FDA 510(k)
Vital Sync Virtual Patient Monitoring Platform 2.6
Medtronic, Inc.
Patient monitoring
FDA 510(k)
Mobile MIM
MIM Software, Inc.
Picture Archiving and Communication System
App store button
FDA 510(k)
SimplECG
Nanowear, Inc.
Heart/Circulatory System, Respiratory system
FDA 510(k)
Naya Health Tracker
Naya Health, Inc.
Patient monitoring
App store button
FDA 510(k)
nfant feeding solution
NFANT Labs, LLC
Infant feeding
FDA 510(k)
Physiotrace Smart
NimbleHearth, Inc.
Heart/Circulatory System
FDA 510(k)
Optum TeleHealth
Optum, Inc.
Teleconsult
App store button
Play store button
FDA 510(k)
Pear reSET-O
Pear Therapeutics, Inc.
Mental Health and Behavioral Disorders, Other
App store button
Play store button
No website
FDA 510(k)
Peerbridge Cor
Peerbridge Health, Inc.
Heart/Circulatory System
FDA 510(k)
PhysioWave Pro
PhysioWave, Inc.
Heart/Circulatory System
FDA 510(k)
POPS! Diabetes care
POPS! Diabetes Care, Inc.
Diabetes
App store button
FDA 510(k)
Proteus Discover
Proteus Digital Health, Inc.
Drug delivery
App store button
FDA 510(k)
your leva
Renovia, Inc.
Musculoskeletal system and connective Tissue, Genitourinary system
App store button
Play store button
FDA 510(k)
Genesis Touch
Resideo Technologies, Inc. (Honeywell spin-off)
Teleconsult
App store button
Play store button
FDA 510(k)
AirMini
ResMed Corp.
Respiratory system
App store button
Play store button
FDA 510(k)
Drowzle
Resonea, Inc.
Respiratory system, Sleep
App store button
FDA 510(k)
Rooti Rx
Rooti Labs, Ltd.
Heart/Circulatory System
App store button
FDA 510(k)
Vue Motion
Royal Philips BV (formerly Carestream Health, Inc.)
Picture Archiving and Communication System
FDA 510(k)
Samsung Health
Samsung Electronics Co, Ltd.
Heart/Circulatory System, Endocrine, Nutritional and metabolic diseases, Other
App store button
Play store button
FDA 510(k)
Trak: Sperm Health & Fertility
Sandstone Diagnostics, Inc.
Genitourinary system, Other
App store button
Play store button
FDA 510(k)
My Dose Coach
Sanofi SA
Diabetes
App store button
Play store button
FDA 510(k)
Wing
Sparo, Inc.
Respiratory system
App store button
FDA 510(k)
Eye-Sync
SyncThink, Inc.
Eyes and Ears
Play store button
FDA 510(k)
ProAir Digihaler
Teva Pharmaceutical Industries, Ltd.
Respiratory system
FDA 510(k)
CoVa 2
toSense, Inc.
Heart/Circulatory System
FDA 510(k)
painKARE
TrioWave Technologies, Inc.
Pain management
App store button
Play store button
FDA 510(k)
Verily Study Watch
Verily (Google Alphabet)
Heart/Circulatory
FDA 510(k)
Fever Scout
VivaLnk, Inc.
Medical Device
App store button
Play store button
FDA 510(k)
Oleena
Voluntis SA
Oncology
FDA 510(k)
BlueStar Diabetes
WellDoc, Inc.
Diabetes
App store button
Play store button
FDA 510(k)
Natural Cycles
NaturalCycles Nordic AB
Birth control / contraception
App store button
Play store button
FDA 510(k), CE IIa
IDEAL LIFE Health App
Ideal Life, Inc.
Teleconsult, Patient monitoring
Play store button
FDA class I
Prescription Check
JAND, Inc. d.b.a. Warby Parker
Eyes and Ears
App store button
FDA class I
Opternative
Visibly (formerly Opternative)
Eyes and Ears
FDA class I
ECG App
Apple
Cardiology
FDA class II
RhythmAnalytics
Biofourmis, Inc.
Heart/Circulatory System
FDA class II
Current
Current Health (formerly snap40)
Patient monitoring, Telehealth
FDA class II, CE IIa
CURVE system
Fresca Medical, Inc.
Respiratory system, Sleep
FDA de novo
Pear reSET
Pear Therapeutics, Inc.
Mental Health and Behavioral Disorders, Other
App store button
Play store button
FDA de novo
Nerivio Migra
Theranica Bio-Electronics Ltd.
Migraine electroceutical
App store button
Play store button
FDA De Novo
Patient controller
Abbott (formerly St. Jude Medical)
Pain management
App store button
FDA PMA
Andaman7
A7 Software SA
Patient monitoring
App store button
Play store button
under investigation
Learn2ACT
Learn2ACT VoF
Mental Health and Behavioral Disorders
App store button
Play store button
under investigation
Scanwell
Scanwell Health, Inc.
Genitourinary system
App store button
Play store button
FDA 510(k)
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