FDA/EU/Health Canada regulatory approval and certification for next generation connected oscillometer


Thorasys designs and commercializes ergonomic devices for clinicians and patients to improve diagnosis and monitoring of diseases such as asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis. As with most devices for the measurement of pulmonary function, the company’s current offering requires specialised professional assistance to conduct the tests. For patients, this implies regular travel to specialized clinics able to offer these services, which can pose access challenges for those living far away from large urban centers.

Thorasys is currently finalizing the technical file for a new generation of devices that are simpler to use, enabling patients to take their own measurements reliably. This project the upgrade of the cybersecurity for the Tremoflo C2, which will be accessible to treating physicians via a connected database and a web-based dashboard . The applicable standards include ISO27001, IEC 62304, IEC 81001-5-1, HIPAA, and the targeted regulatory approvals are the FDA, Health Canada and EU MDR. This product will shortly be included in a clinical study on the follow up of post-lung transplant patients.

For Thorasys, this enhanced connectivity means an improved logistical functionality for its main business segment: the support of pharmaceutical clinical studies targeting new molecules for pulmonary diseases. On the clinical side, the company will be able to increase its reach from specialists such as pulmonologists to general practitioners, a much large potential market.