In February 2018, Amiko announced CE marking for Respiro sensors used with Teva Spiromax, Chiesi Nexthaler and GlaxoSmithKline Ellipta inhalers.
Respiro paired inhaler sensors with the software around them. Automatic capture brought two parts of each inhalation into view: when the inhaler was used and how the technique looked.
The announcement reported conformity under Directive 93/42/EEC, supported by an ISO 13485:2016 quality system. It marked an early step in bringing connected inhaler technology into respiratory care.
"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.
Historical note: this article records the product-specific milestone announced in 2018. For current product information, consult the applicable instructions for use or contact Amiko.