FDA Aims to Improve Medical Device Security
The agency has issued proposed draft recommendations to guide incorporation of cybersecurity protections into medical devices at the time of manufacture.
Medical Devices
Evoke SCS System Approved for Chronic Intractable Pain
Evoke is a novel, closed-loop SCS system that instantaneously reads, records, and responds to evoked compound action potentials.
Senza SCS System Approval Expanded to Include Nonsurgical Refractory Back Pain
The Senza SCS System is a neuromodulation device designed to deliver electrical stimulation using implantable leads and a rechargeable, implantable pulse generator.
Digital Health App Tracks Pain Progress With Neurostimulation Therapy
Patients will be able to share information collected in the app with health care providers to provide a comprehensive assessment of the SCS or DRG therapy.
Latest Health Technology at CES 2021
MPR highlights health innovations from the 2021 Consumer Electronics Show (CES).
FDA Authorizes Digital Therapeutic for Sleep Disturbance in PTSD
NightWare is a smartwatch application that uses the Apple Watch and Apple iPhone platform.
FDA Approves DBS Neurostimulation System With Brain Signal Tracking
The FDA has approved the Percept™ PC Deep Brain Stimulation (DBS) system (Medtronic) with BrainSense™ technology for neurological disorders.
Infinity DBS System Gains Expanded Approval for Parkinson Disease Management
The FDA has approved an expanded indication for the Infinity™ Deep Brain Stimulation (DBS) system (Abbott) to include targeting the internal globus pallidus, which may lead to symptom improvement in patients with Parkinson disease.
Wearable Device Data May Help Predict Flu-Like Illness Patterns
Fitbit data significantly improved prediction of influenza-like illness in top five states with most users
FDA Approves Unique SCS System for Chronic Pain
The Food and Drug Administration (FDA) has approved the Senza Omnia Spinal Cord Stimulation (SCS) System (Nevro) for the treatment of chronic intractable pain of the trunk and/or limbs. The Omnia SCS system is the first to deliver Nevro’s proprietary HF10 therapy (continuous stimulation at 10,000 Hz) as well as all other available SCS frequences…
