Aurika Savickaite
Updated: May 2, 2022
As of August 14th, 2020. StarMed Helmet is approved by the FDA to use for non-invasive ventilation and CPAP in the hospital environment. The treatment may only be performed under careful monitoring by expert operators. Suitable for treatment of respiratory insufficiency in hypoxemic/hypercapnic adult patients.
You can send your inquiry directly to the manufacturer here
Hands-On Review Video - NIV StarMed CaStar R Hood from Intersurgical Ltd
DIMAR CPAP and NIV helmets received FDA EUA approval on April 20th, 2022.
"Effective August 4, 2020. The device has been added to Appendix B of the FDA’s EUA for ventilator accessories, and is specifically indicated for the treatment of ARDS resulting from Covid-19. At the present time, the Subsalve Oxygen Treatment Hood is the only such device with this specific indication as authorized by the FDA" Michael Lombardi.
4/9/2020 Lombardi Undersea LLC in partnership with Subsalve USA, both of Rhode Island USA is producing and shipping oxygen treatment hoods. Orders can be placed online or by submitting a PO to Michael Lombardi at michael@lombardiundersea.com.
The nHale + Hood configuration
nHale™ provides bi-level positive air pressure and CPAP to support respiratory therapy for spontaneously breathing adults.
An instructional video for nHale and Subsalve hood connection:
PEEP-Alert is an accessory that provides continuous monitoring of positive pressure therapy and has Audible/visual alarms.
Authorized by the FDA for Emergency Use (EUA) and by Health Canada under COVID-19 Interim Order
USA Manufacturer Texas
Sea-Long Medical Systems Inc Waxahachie, TX 75167
USA Manufacturer California
Amron International, Inc Vista, California
Mike Malone, Vice President Sales, Phone: 760.208.6500
Filed for FDA EUA Approval
You can order this helmet directly from the manufacturer here.
Hands-On Review Video - VYATIL Oxygen Tent from The LMD Power of Light
SouthMed Dunedin, New Zealand. Sales contact: enquiries@southmed.co.nz
Suzy MCP-001 Respiratory Hood available in New Zealand
DIMAR s.r.l. Medolla, Italy
Harol, Milan, Italy Video instructions.
Intersurgical Ltd. Mirandola, Italy
Armstrong Medical. Coleraine, Northern Ireland.
CPAP Helmets / Hoods deliver CPAP safely
while providing great patient comfort and aerosol-protection for staff:
The FD140i provides a dedicated CPAP Helmet Mode
with enhanced safety features:
Intersurgical Ltd. Berkshire, UK
Italian manufacturer's representative: UAB Intersurgical Arnionių g. 60, LT-18170 Pabradė, Lietuva
Hands-On Review Video and more info about Haven Hood
Alberta COVID CPAP Hood - Scott Loree "I have been working for 4 weeks with Tom Vermeeren, from Gemma Plastics in Edmonton, Alberta, to develop a locally manufactured version of this helmet system. We have received Health Canada approval 4/24/2020, and are ready to move into manufacturing. "
DYI initiative by Marek Macner - Helmochron is in Polish language new word - helm = helmet and ochrona = protection.
Filed for FDA EUA Approval
A manufacturer located in Zeeland, MI. They have been working with multiple hospitals testing helmets. You can order a helmet here. Contact: Nick Flesher phone: 616-283-3342
(Updated daily) Our goal is to help make more helmets faster and educate medical professionals! We are adding information about companies offering to help to this public spreadsheet so everybody can connect directly (started on 4/1). Link: https://hi.switchy.io/HELP-Make-Helmets
The objective of this group is to design and create a working NIV Helmet and to release all associated 3D printing files, bill of materials, and building instructions online so that anyone around the world may build one in an emergency situation in order to Combat COVID-19.