Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Synapse Awaits Humanitarian Approval For Diaphragm Pacing System To Treat ALS

This article was originally published in The Gray Sheet

Executive Summary

Synapse Biomedical expects FDA to issue a humanitarian device exemption within weeks allowing its NeuRX diaphragm pacing system to be marketed to treat patients with amytrophic lateral sclerosis.

You may also be interested in...



New Products In Brief

Synapse Biomedical’s NeuRx

New Products In Brief

Synapse Biomedical’s NeuRx

Synapse Biomedical Debuts Diaphragm Pacer, HDE-Cleared To Aid Breathing

Synapse Biomedical will pursue expanded approval of its diaphragm pacing system to facilitate breathing in patients with Lou Gehrig's disease after gaining a humanitarian device exemption June 17 for use by ventilator-dependent spinal cord injury patients, according to the company

Topics

UsernamePublicRestriction

Register

OM014142

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel