FDA greenlights the Dario Blood Glucose Monitoring system
The system consists of the Dario Blood Glucose Meter, Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario iOS app.
GI Logic’s AbStats System receives FDA 510K clearance for real-time digestive telemetry
The system allows care providers to see digestive signals as they occur and evaluate the rate of digestive activity to determine when the GI tract re-engages.
Viatom’s Checkme Pro medical tricorder clears the FDA
The device can perform one-lead ECG recording, pulse oximetry, temperature measurement, and movement sensing, among other things.
Android for Gmate SMART mobile diabetes monitoring system clears the FDA
The Gmate SMART is a small, portable blood glucose meter that plugs into the headphone jack of a smartphone and provides fast blood glucose test results.
FUJIFILM SonoSite’s portable ultrasound solution iViz clears the FDA
With iViz, clinicians can easily access learning resources and patient information, store exam findings, submit reports, and consult with remote providers.
Medtronic’s app-based remote monitoring system for pacemakers clears the FDA hurdle
The company is also announcing the U.S. product availability allowing patients to use own mobile devices to transmit data from their pacemakers to physicians.
Visible Patient gets the FDA nod to bring its custom 3D anatomy models to...
VP Planning Software Suite allows surgeons to send radiological data to Visible Patient where in-house designers create 3D models based on the data received.
FDA looking for comments on mHealth in clinical trials
The agency wants to know how healthcare providers and other parties are using consumer-generated data, and whether the data being collected is reliable.
Reflexion Health’s remote monitoring tool for physical therapy clears the FDA
Called Vera, it is designed to help people recovering from injuries do their physical therapy from home, while allowing therapists to collect patients' data.
Masimo’s MightySat Rx Fingertip Pulse Oximeter clears the FDA
The device noninvasively measures arterial oxygen saturation and pulse rate, in addition to perfusion index and optional pleth variability index.