Medical Devices

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…

MPR Weekly Dose Podcast: Episode 7

This week we talk about the new Invokana approval; The ranitidine recalls that led CVS to suspend all sales; The 11 serious cybersecurity vulnerabilities identified by the FDA that could affect medical devices and hospital networks; Entresto’s expanded indication; and the investigative COPD treatment that was rejected.

FDA: Cybersecurity Vulnerabilities Identified With Certain Medical Devices, Hospital Networks

The Food and Drug Administration (FDA) has issued an alert regarding a set of cybersecurity vulnerabilities that may potentially introduce risks for certain medical devices and hospital networks.  Security researchers have determined 11 vulnerabilities, referred to as “URGENT/11”, that may potentially allow an unauthorized user to take control of a facilities’ medical network leading to…