Before Respiro could become infrastructure, it had to clear the bar every medical device clears: a CE mark. In February 2018 it did, for use with three of the inhalers patients already hold every day, Teva's Spiromax, Chiesi's Nexthaler and GlaxoSmithKline's Ellipta.
Respiro pairs inhaler sensors with the software around them. The sensors capture each inhalation automatically, recording both when a dose is taken and how well the technique holds up.
CE marking is what lets a medical device go on sale in the EU: proof it meets the essential requirements of the European Medical Device Directives. Respiro met Directive 93/42/EEC, and we built the work on an ISO 13485:2016 quality system, the standard that still underpins everything we ship.
"Respiro's medication sensors capture data on true adherence behaviour, which better reflects real-life patient inhaler use, as compared to traditional measures of adherence."
Dr Job F.M. van Boven, Assistant Professor of Drug Utilization Research, University Medical Center Groningen
"Receiving the CE mark is a significant milestone toward the global commercialisation of our connected inhaler technology."
Duilio Macchi, Amministratore Delegato, Amiko
Originally published 5 February 2018. Spiromax, Nexthaler and Ellipta are registered trademarks of their respective owners.