Founded by Roger Avery in the late 1960s, Avery Biomedical Devices makes implanted diaphragm pacemaker systems that stimulate the phrenic nerves to support breathing. The company’s predecessor introduced the first commercially distributed diaphragm pacemaker in 1971, and Avery has since manufactured more than 10,000 neurostimulators implanted in over 50 countries. Renamed in 2005, the Long Island manufacturer’s Spirit system has full FDA approval for adult and pediatric use and is produced under an ISO 13485 quality system.
ISO 13485:2016 Quality Management System
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FDA Premarket Approval P860026
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CE Marking under the European Active Implantable Medical Device Directive
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United States FDA Device Registration and Inspection
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Argentina ANMAT Registration
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Colombia INVIMA Registration
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Israel Ministry of Health Medical Device Registration
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Russian Ministry of Health Registration
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United Kingdom MHRA Registration
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Synapse Biomedical IncFounded in 2002, Oberlin-based Synapse Biomedical develops and manufactures neurostimulation medical devices that help patients breathe and recover movement. Its FDA-approved NeuRx Diaphragm Pacing System supports diaphragm conditioning for people with spinal cord injuries and ALS, while the company’s TransAeris system is designed to address ventilator-induced diaphragm dysfunction. Synapse says its NeuRx products are manufactured in Ohio at an ISO 13485-certified facility and have been used to treat more than 2,000 patients.OBERLIN, OH
Lungpacer Medical IncFor more than 15 years, Lungpacer Medical has developed neurostimulation technologies for critical care, including the AeroPace temporary transvenous system that activates the diaphragm to help mechanically ventilated patients regain independent breathing. The company’s work spans clinical research and engineering, with its first human diaphragm-pacing use in 2015 and FDA premarket approval for AeroPace in 2024. Based in Vancouver with U.S. operations in Exton, Pennsylvania, Lungpacer is also studying continual diaphragm stimulation through its investigational AeroNova system.EXTON, PA
VapothermFor more than 25 years, Vapotherm has made respiratory-support devices built around high velocity therapy, its mask-free approach for spontaneously breathing patients from premature neonates to adults. Based in Exeter, New Hampshire, the medical-device company’s portfolio includes the HVT 2.0 and Precision Flow systems, alongside a portable ventilator developed with Flight Medical. Vapotherm products are used in more than 2,400 hospitals across over 40 countries.CINCINNATI, OH
Drive DeVilbiss HealthcareSince its founding in 2000, Drive DeVilbiss Healthcare has grown into a global medical-equipment manufacturer with offices, factories and warehouses across several continents. The company is known for building practical equipment that supports independence, serving homecare providers, long-term-care organizations and other healthcare channels in more than 100 countries.PORT WASHINGTON, NY