Air Collective Forum

Device Approval Initiative

After mapping open ventilator projects around the world, we currently see 2 ventilator designs demonstrate local reproducibility, and reach the most credible approval stages with their national regulators. These are ready to be taken to regulatory approval in every country:

  1. The UCL-Ventura, co-developed by UCL Hospital and Mercedes-AMG’s Formula One team, this CPAP device has already been approved for use by the UK NHS.

  2. The Oxygen, co-developed by Protify, Hospital Clínic, Hospital Germans Trias i Pujol and the UB of Barcelon , is an ambubag driver that can manufactured or 3D-printed, and is undergoing clinical testing by AEMPS (Spanish Agency for Medicines and Health Products) and is under production at SEAT.

(More may be added to this list should they publish reproducible schematics, design files and source code. We are open to supporting other models should they be equivalently progressed.)

These are the most progressed projects in terms of reproducibility and likelihood of further authorizations from other national authorities, so we are mobilizing our resources around helping local manufacturing teams obtain national authorizations for their use in hospitals. (Note: authorization for emergency pandemic use is often a lighter process than standard medical device certifications, which will take too long.)