Inventory of 31 digital medical products approved by the FDA in 2014
This year, MobiHealthNews reported a number of significant advances in digital healthcare , including four initial public offerings (IPOs) raising $2 billion, 33 mergers and acquisitions, and the first presence of some established companies. However, this year the FDA has some important initiatives in the digital healthcare arena.
In August, the FDA banned a significant number of Class I and Class II medical devices , including thermometers, smart body meters, stethoscopes, and certain eye cameras. These devices are no longer required for 510(k) applications. However, according to MobiHealthNews, there are still 31 types of digital medical-related apps and devices approved by the FDA this year. For example, an app that can estimate blood loss during surgery through a camera on IPad, a thermometer connected to a smartphone, and The IOS application for the treatment of tinnitus, and the chair that shows vital signs – even the mysterious application “LG Smarthealth†from LG Korea.
Below are 31 FDA-approved App and devices related to digital healthcare.
the first season
Kinsa Health's Kinsa Smart Thermometer. The thermometer can be used to measure the temperature of the mouth, underarms and rectum and then transmit the data to the smartphone client.
Samsung's S Health App. As a signal transmitter for heart disease, the app can connect to other medical devices.
Waltham's Massachusetts-based Early Sense II. This passive, non-contact bedside monitoring system continuously monitors the user's respiratory rate, heart rate and movements.
Alere Connect's latest home health hub (hub) Homelink. Homelink allows users to self-test and transmit data to healthcare providers.
The British company Camntech's Motion Tracking Bracket (Motion Watch 8) and the wearable wristband electronic log (PRO-Diary). These devices may be used in clinical trials.
Carestream's VUE Motion. This is a mobile phone software for viewing and reading radio images, which can be used on mobile devices such as iPhone 4s, iPad 2, Galaxy Note and Galaxy S III.
HealthInterlink's Beacon 2.0. Beacon was previously classified as a Class I medical device. The latest Beacon 2.0 license is a Class II medical device that integrates different family medical data centered on the mobile software system.
Second quarter
A smart inhaler from Propeller Health that records data from patients with asthma or chronic lung obstruction.
Qardio's QardioArm. The device is a connectable blood pressure monitor.
New Zealand's medical device company Nexus6's SmartTouch. As an inhaler for smartphones, Smartouch can meter inhaled drugs according to prescriptions and is widely used in clinical trials, clinical practice, and patient self-management.
CardioMEMS' CardioMEMS HF system. The system monitors pulmonary blood pressure. However, it can only be used for patients who meet the following criteria: 1) meet the third-grade heart failure of the New York Heart Association (NYHA); 2) have a history of hospitalization for heart failure.
ResolutionMD from Calgary Scientific, Canada. ResolutionMD is a medical diagnostic imaging software that can be used for all imaging methods except mammography.
McKesson's Mckesson Cardiology ECG Mobile. This app allows clinicians to analyze and review ECG waveforms from ECG devices from different vendors.
CS App for InTouchHealth. The CS App can perform a similar real-time digital auscultation effect, transmitting patient data remotely to the doctor.
ReflectanceMedical's Multi-Parameter Mobile Care Guide 3100 Oximeter system. According to the company's description, this oximeter system provides a non-invasive measurement of hemoglobin oxygen saturation and pH in skeletal muscle tissue in the area where the sensor is located.
Vital Connect's Vital Connect Platform. This platform supports the company's HeartPatch. The device is a band-aid-like stripping device for monitoring single-lead ECG, heart rate, heart rate variability, respiratory rate, skin temperature, body posture (detecting falls), pace, pressure, and sleep cycle.
Gauss Surgical's Triton Fluid Management System. This app can estimate the amount of bleeding during surgery through the iPad's camera.
MyHealthPoint telemedicine manager of Entra Health Systems. This telemedicine management software collects biometric data from stored users from a variety of sources, including blood glucose, blood pressure, weight, body composition, activity, body temperature, electrocardiogram, and pulse oximetry.
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