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.
Medical Devices
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…
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…
FDA Clears Smartwatch, Patch for Cuffless BP Monitoring
The FDA has granted 510K clearance to BioBeat’s wearable watch and patch for continuous monitoring of blood pressure, heart rate and oxygenation.
Cochlear Implants for Single-Sided Deafness, Asymmetric Hearing Loss Get FDA Approval
The FDA has approved SYNCHRONY and SYNCHRONY 2 (MED-EL) cochlear implant systems for single-sided deafness and asymmetric hearing loss.
ProVate Gets FDA Approval to Treat Pelvic Organ Prolapse
The FDA has approved ProVate (ConTIPI) for the temporary, nonsurgical management of pelvic organ prolapse in women.
FDA Grants Breakthrough Status to a Digital Intervention Tx for Nightmares in PTSD Patients
The Food and Drug Administration (FDA) has granted Breakthrough Status designation to NightWare (NightWare, Inc.), a digital intervention therapy that measures and treats nightmares in patients with post traumatic stress disorder (PTSD).
