Tag: FDA
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 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 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...
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...
How Health Wearables Are Improving Patients’ Lives
The proliferation of wearables such as Fitbit to FDA approved medical devices shows that wearable tech is poised to disrupt the healthcare industry.Estimated worldwide...
Nightware Receives FDA Breakthrough Status for its PTSD Nightmare Therapy App
Many people suffering from post-traumatic stress disorder (PTSD) experience nightmares on a regular basis. Nighttime memories often manifest as distressing dreams or nightmares in...