FDA Clears Novel Device for Upper Extremity Rehabilitation After Stroke
The device is available only with a prescription and may be used as part of rehabilitation therapy.
Devices
Tongue-Delivered Neuromodulation Therapy Gets FDA Clearance for MS-Related Gait Deficit
PoNS is a portable, noninvasive, prescription-only device intended to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older.
FDA Approves Device That May Offer Alternative to Open-Heart Surgery
Primary effectiveness of no additional surgical or interventional procedures related to the device and acceptable heart blood flow function at 6 months, was achieved by 89.2%.
NeuroSphere Virtual Clinic Allows for Remote Neuromodulation Therapy Management
Using the programmer app, clinicians are able to remotely prescribe new treatment settings to the patient’s neuromodulation device via cloud and Bluetooth-based technology.
FDA Clears Wearable Brain Neuromodulation Device for Acute Migraine
Relivion is worn as a headset delivering stimulation to 6 branches of the occipital and trigeminal nerves through 3 adaptive output channels.
EndoClot PHS Approved to Control Bleeding During GI Procedures
EndoClot PHS is a single-use device consisting of a starch-based powder hemostat to control bleeding in the GI tract.
FDA: Certain Factors May Affect Pulse Oximeter Accuracy
According to the FDA’s safety communication, multiple factors may affect the accuracy of pulse oximeter readings, including poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish.
FDA Approves 3D Printed Implant for Avascular Necrosis of the Talus
The approval is supported by data from 31 patients and 32 talus replacement surgeries.
FDA Clears Vagus Nerve Stimulation Device for Adolescent Migraine
Findings from an adolescent study showed that 46.8% of treated attacks were successfully resolved without the use of any acute rescue medication.
Nerivio Device Cleared for Migraine in Adolescents
The approval was based on data from an open-label, single-arm study that evaluated the efficacy and safety of Nerivio in patients aged 12 to 17 years with migraine.
