Amiko Digital Health Limited (Amiko), a company that develops advanced medication sensor technologies and AI-powered digital health tools, declared today that the company has received CE Mark for use of the Respiro platform with Teva's Spiromax inhaler, Chiesi's Nexthaler inhaler and GlaxoSmithKline's Ellipta® inhaler.
“Respiro’s medication sensors capture data on true adherence behavior, which better reflects real-life patient inhaler use, as compared to traditional measures of adherence” said Dr. Job FM van Boven, assistant professor of Drug Utilization Research at the University Medical Center Groningen, The Netherlands. “This information can support us better understand the efficiency of an inhaled drug therapy, and support the development of personalized and cost-effective interventions promoting adherence and correct inhaler technique”.
Respiro offers advanced inhaler sensors and connected health tools, enabling real-time monitoring of medication use and patient health. At the core of the platform: Respiro Sense, the technology that powers the world’s most advanced inhaler sensors. Combined with inhalers for asthma, COPD and CF, the sensors automatically capture data on the patient’s inhalation profiles to monitor when and how well patients use their medication.
CE marking is the medical device manufacturer’s claim that a product meets the important needs of all relevant European Medical Device Directives. The directives outline the safety and performance requirements for medical devices in the European Union. The CE Mark is a legal necessity to place a device on the market in the EU. The CE mark shows that Amiko has complied with The European Medical Device Directive 93/42/EEC regarding medical devices.
"Receiving the CE Mark is a significant milestone toward the global commercialization of our connected inhaler technology. By successfully completing this procedure, Amiko has demonstrated that Respiro complies with applicable EU’s health and safety legislative requirements and it can now offer the technology for clinical and commercial use to healthcare providers and research institutions in the EU” commented Federica Iovine, Director of Regulatory Affairs at Amiko.
In addition to receiving the CE Mark, Amiko has also received ISO 13485:2016 certification, an international standard governing the needs of a quality-management system for medical devices and related services.
With its ISO 13485:2016 Certification and CE Mark, Amiko is expected to begin the commercialization of Respiro into Europe this year.