Psychedelic-focused biotech company Mind Medicine Inc. MNMD MMED MMQ recently met with the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) with consultation from the Center for Drug Evaluation and Research (CDER) to discuss several key points for ongoing development of the MindMed Session Monitoring System.
During a device pre-submission meeting, which was held on October 25, MindMed presented the FDA with a working Indications for Use statement (IFU) and a development roadmap.
The real-time monitoring system assists in assessing a patient's physiological and behavioral state during a psychedelic-assisted therapeutic session.
The company laid out more details, describing technology and infrastructure for the collection of precise, multimodal, multivalent data that can be processed via machine learning, artificial intelligence, signal processes, and other statistical methods to yield clinically meaningful output to satisfy the requirements of the IFU.
“These regulatory engagements provide the opportunity to thoroughly and continually discuss and assess alignment around the various considerations, which are essential to the success and adoption of MindMed’s Session Monitoring System’s regulated components,” said Daniel R Karlin, MD MA, chief medical officer of MindMed.
The FDA provided key feedback regarding the draft IFU and research methods to lay the foundation for regulatory submissions.
“The FDA is supportive of our plans to develop regulated devices that would allow the use of novel analyses of multimodal data to capture, model, and map outputs that, if cleared, could be useful to clinicians and patients in the delivery of psychedelic and other perception-altering substances.”
More recent news from MindMed:
- MindMed Q3 Earnings: Big Improvement, Kicks Off Sleep & Cognitive Study With Dose Low-Dose LSD
- MindMed Teams Up With Sphere Health To Identify Biomarkers Associated With Anxiety & Depression
MNMD Price Action
MindMed’s shares traded 0.53% higher at $257.45 per share during the pre-market session on Thursday morning.
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