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FDA Digital health

FDA Advancing Digital Health to Accurately Diagnose and Treat Disease and Enhance Delivery of...

Digital health encompasses a wide range of novel digital technologies related to health and medicine. These include mobile health (mHealth), health information technology (IT),...
FDA supports AI in Telemedicine

How FDA is Backing the Use of Artificial Intelligence in Telemedicine

Telemedicine, also known as e-medicine, is the remote delivery of healthcare services, including tests and consultations, over the telecommunications infrastructure. Telemedicine allows health care...
SweynTooth vulnerabilities

FDA: “SweynTooth” Cybersecurity Vulnerabilities Found in Certain Medical Devices with Bluetooth Low Energy

The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and manufacturers about a set of cybersecurity vulnerabilities, referred to as...
Abbott FDA DBS system

Abbott Secures FDA’s Expanded Indication for its Deep Brain Stimulation System for Parkinson’s Treatment

Abbott’s Infinity Deep Brain Stimulation (DBS) system has received an expanded clearance from the U.S. Food and Drug Administration (FDA) to include targeting of...
Medtronic buys Klue

Medtronic Buys Diabetes Management Startup Klue to Strengthen Personalized Closed Loop System

Irish Medtech giant Medtronic has acquired California-based Klue, a startup that uses gesture sensing and other behavioral health metrics to determine when a user...
Eversense CGM Recalled

FDA Issues Recall for Eversense Continuous Glucose Monitoring System

The US Food and Drug Administration (FDA) has issued a recall for Senseonics’ Eversense Continuous Glucose Monitoring (CGM) system. Read more Senseonics & Glooko Partner...