Incannex Meets with FDA in Pre-IND Meeting for Sleep Apnea Drug Candidate
Incannex characterized the pre-investigational new drug application (pre-IND) meeting about IHL-42X as “highly constructive.”
Incannex characterized the pre-investigational new drug application (pre-IND) meeting about IHL-42X as “highly constructive.”
Developed with cardiologists and sleep experts, it has been used in a study to monitor COVID patients remotely in German hospitals.
"Use of these devices may cause serious injuries or death," the FDA now says.
The FDA has provided answers to frequently asked questions related to the Philips CPAP, BiPAP, and ventilator recall.
Read MoreThe designation was based, in part, on early phase and preliminary clinical data that indicates Takeda’s investigational oral orexin agonist may demonstrate substantially improved objective and subjective measurements of daytime wakefulness in NT1 patients.
Read MoreFDA: Getting treatment for obstructive sleep apnea or OSA can save your life and help you feel better every day.
Read MoreReport any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.
Read MoreThis randomized controlled trial will take place at approximately 20 sites across the United States and will enroll a maximum of 150 adult patients with moderate to severe OSA who do not achieve results from a traditional CPAP machine or have declined its use.
Read MoreThe FDA also published its summary of clinical superiority findings for Xywav for the treatment of cataplexy or excessive daytime sleepiness associated with narcolepsy.
Read MoreA popular vitamin brand recalled some of its gummy products because they could contain metal.
Read MoreThis revised labeling ensures that patients who receive the Genio system and those already implanted can now undergo full-body 1.5T and 3T MRI diagnostic scans within approved parameters.
Read MoreIt’s been an unusual year. But, mostly as usual, the US Food & Drug Administration continued to review device and drug applications across all fields of medicine.
Read MoreThe Luna G3 Auto BPAP is available with integrated heated tubing, cellular connectivity, and an algorithm that auto-adjusts pressure settings.
Read MoreThe FDA approval is for children as young as 2 years old. Specific analysis templates for children are available in DOMINO software.
Read MoreEVO is the first oral appliance to use ProSomnus’ MG6 technology, which combines high-performance medical-grade materials, manufacturing robotics, and AI.
Read MoreThis change to Zephyr Sleep Technology’s MATRx plus makes setting up the take-home sleep appliance treatment planning test simpler for the patient and easier for the dental team to dispense.
Read MoreMade of N99-rated filter material, the patent-pending PortPatch is intended to reduce the spread of airborne particulates.
Read MoreThe decision allows Lumin to be used by healthcare workers employed in nursing homes, long term acute care, ambulatory, primary care, and clinics to allow N95 re-use to stop the spread of COVID-19.
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