Capsule’s patient monitoring system clears the FDA
Called SmartLinx Vitals Plus, the solution integrates vital signs monitoring, documentation and connectivity in a single device.
NFANT Labs’ smart infant feeding solution gets FDA clearance
The nfant Feeding Solution monitors infants' tongue movements during feeding to provide objective, measurable data, accessible from a connected mobile device.
Intelesens’ zensor gets FDA 510(k) clearance
The small device can be worn for seven days at a time, while collecting data on respiration rate, three-lead ECG, heart rate and motion.
FDA clears LifeWatch’s ACT software on Android
This clearance is part of the company's plan to introduce a universal gateway, which will also run on Android and is currently under development.
First digital medicine starts its journey with the FDA
A drug/device product combines Otsuka's ABILIFY for serious mental illness, embedded with the Proteus ingestible sensor in a single tablet to record ingestion.
FDA clears Eko’s digital stethoscope
Called CORE, the device can wirelessly stream heart sounds to a smartphone app and integrate heart sounds directly into the patient's electronic health record.
HealthWatch’s MasterCaution Device clears the FDA hurdle
The agency cleared it as a Class II medical device intended to condition electrocardiogram (ECG) signals for digital transmission via Bluetooth.
Dexcom G5 Mobile CGM system clears the FDA
This is the first and only full mobile CGM system that allows adults and children as young as 2 years old to conveniently monitor and share glucose levels.
Noninvasive glucose monitoring device GlucoTrack starts its regulatory journey with the FDA
The product, developed by Integrity Applications, comes in the form of a clip the user places on his or her ear to take readings without drawing blood.
precisionFDA to enable genomic researchers to collaborate
The platform will enable next generation sequencing (NGS) researchers to share and cross-validate their tests/results against crowd-sourced reference material.