Dario Blood Glucose Monitoring system

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

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.
Checkme Pro

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.
Gmate smart

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 iViz

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.
MyCareLink Smart Monitor

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

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 logo

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 - Vera

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.
MightySat Rx

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.