Inventory of 23 digital health-related apps and devices approved by the FDA to date

Release date: 2014-10-23

In fiscal 2014, the FDA has approved 23 apps and devices related to digital health.

 
Q1: 7 models
 
Kinsa Health, the Kinsa smart thermometer for the mouth, lower arm or rectum, transmits data to a companion smartphone app.
 
Samsung, the S Health app, acts as a cardiologist signal transmitter that interfaces with other connected medical devices.
 
EarlySense, the Early Sense Beside Unite, a passive, non-contact bedside monitor that continuously monitors respiratory rate, heart rate, and motion as a sensor to monitor a patient's clinical condition.
 
Alere Connect, a home health hub, enables patients to self-test at home and quickly and seamlessly transfer data to clinical systems accessible to healthcare providers.
 
Camntech, Inc. - MotionWatch and PRO-Diary, a sports tracking watch and wrist-worn electronic diary, may be used clinically.
 
Carestream, Inc. - VUE Motion, a mobile radiology viewing and reading software for iPhone 4s, iPad 2, Galaxy Note and Galaxy S mobile devices.
 
HealthInterlink, Beacon 2.0, a mobile center software system that integrates data from a variety of home medical devices.
 
Q2: 11 models
 
Propeller Health, a platform that combines smart inhalers for patients with asthma or chronic obstructive pulmonary disease (COPD).
 
Qardio - QardioARM, a blood pressure monitor
 
Nexus6, SmartTouch, a smartphone-connected inhaler, acts as a prescription metered dose inhaler (MDI) for clinical trials, clinical practice, and patient self-management.
 
CardioMEMS, the CardioMEMS HF System, monitors pulmonary hypertension.
 
Calgary Scientific, ResolutionMD, a diagnostic medical imaging software that vendors can use for all imaging modalities, except for mammography.
 
McKesson, Inc. - McKesson Cardiology ECG Mobile enables clinicians to analyze and review ECG waveforms captured by various ECG devices.
 
InTouch Health, the CS App, is an application that allows auscultation from a digital stethoscope in an approximate real-time manner.
 
Reflectance Medical, Inc. - Multi-Parameter Mobile CareGuide 3100 Oximeter system, a multi-parameter mobile CareGuide 3100 oximeter system, provides a non-invasive assessment of oxygen saturation and pH in skeletal muscle tissue beneath the sensor.
 
Vital Connect, the Vital Connect Platform, supports the company's vital sign monitor HeartPatch, a wearable device that captures single-lead ECG, heart rate, heart rate variability, respiratory rate, skin temperature, body posture (fall detection), walking, stress, sleep stage.
 
Gauss Surgical, the Triton Fluid Managment System, is an application that uses the iPad's camera to estimate blood loss and the amount of surgical sponge used during surgery.
 
Entra Health Systems, Inc. - MyHealthPoint Telemedicine Management System, an online mobile software that stores biometric data from a variety of sources, measuring vital signs including blood sugar, blood pressure, weight, activity, body temperature, electrocardiogram, pulse and oximetry degree.
 
Q3: 5 (as of September 24)
 
Global Kinetics, Personal KinetiGraph, a wearable device that monitors and treats Parkinson's disease, provides comprehensive automated reporting of Parkinson's patient activities, making it easier for neurologists and other physicians to identify changes in motor symptoms To help make decisions to optimize treatment.
 
Otoharmonics, the Levo system app, an iPad and iPad Touch app that helps treat tinnitus.
 
dorsaVi, the ViMove sensor system, tracks body movements and muscle vitality for clinical or athlete training.
 
AliveCor, a kind of atrial fibrillation algorithm, uses its smartphone electrocardiogram (ECG) sensor to detect atrial fibrillation with high accuracy.
 
Philosys, Gmate Smart, a blood glucose meter that allows smartphones to connect.

Source: Medical consultation

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