FDA Clears Automated Ear Cleaning Device for Earwax Removal
OtoSet is an automated ear cleaning device that resembles a set of headphones.
Devices
Nerivio Device Cleared for Use in Patients With Chronic Migraine
Previously, the device had only been approved in those with episodic migraine.
Cefaly Dual Migraine Treatment Now Available Over-the-Counter
Previously, the external trigeminal nerve stimulator was only available with a prescription.
MPR Weekly Dose Podcast Episode 50
We cover AstraZeneca’s decision to pause their COVID-19 vaccine trial; New studies indicate benefits for steroid therapy in COVID patients; Higher doses of diabetes treatment gain approval; The first non-hormonal contraceptive is launched; The FDA issues a letter regarding spinal cord stimulators; And we wrap up the latest news on drugs in the pipeline.
FDA: Stimulation Trial Should Be Performed Before Implanting SCS for Pain
The FDA reported that between July 27, 2016 and July 27, 2020, a total of 107,728 medical device reports (MDRs) associated with SCS devices intended for pain were received.
Intravaginal Home-Use Device Cleared for Stress Urinary Incontinence
Flyte is an in-home treatment designed to strengthen and treat weakened pelvic floor muscles.
EyeArt Autonomous AI System Cleared for Diabetic Retinopathy Screening
EyeArt is the first FDA-cleared AI technology for autonomous detection of more than mild diabetic retinopathy and vision-threatening diabetic retinopathy.
App Approval Provides Flexibility for Patients Treated With Abbott’s Neuromodulation Devices
The FDA has approved an iOS-compatible app designed to work in tandem with Abbott’s neuromodulation technologies. The Company hopes the app will eliminate the need for patients to carry a separate programmer device and improve remote care.
Implantable Neurostimulation Device Cleared for Chronic Low Back Pain
The FDA has approved ReActiv8® (Mainstay Medical), an implantable neurostimulation system, for the treatment of intractable chronic low back
Update on Potential Risks Associated With Liquid-Filled Intragastric Balloons
Post-approval study results on the risk of hyperinflation, acute pancreatitis, and death associated with the use of liquid-filled intragastric balloons have been made available by the FDA.
