FindAir, a leader in digital medicine and connected medication-data infrastructure for inhaled therapies (Poland), has officially received FDA 510(k) clearance from the US Food and Drug Administration for its smart inhaler add-on.
Its solutions have earned the trust of both public and private healthcare sectors in Europe, with full system deployments in over 50 hospitals, including within the UK’s National Health Service (NHS) and major medical centers in France and the Netherlands (where it supports cost optimization, such as verifying patient adherence before escalating to expensive biologic therapies).
This decision provides the US Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM) sectors with access to a proven, certified technology that is fully reimbursable under the standard respiratory care framework.
Securing regulatory clearance for this first add-on device translates into immediate operational readiness for the company in the US market. Furthermore, it establishes a streamlined pathway for subsequent FDA submissions for other devices built on the same proven technological platform, tailored to the needs of US patients.
FindAir’s business strategy centers on a pure B2B technology model. The company does not operate as a traditional RPM platform or a full-service care provider. Instead, FindAir delivers the historically missing, objective respiratory medication-data layer directly into its partners’ existing software ecosystems.
Through seamless integration via ready-made APIs and SDKs, US RPM/RTM platforms can effortlessly expand their monitoring programs to encompass asthma and COPD patients.
For healthcare operators, the definitive advantage is that FindAir automatically replaces unreliable, subjective patient diaries with hard data straight from IoT devices (including precise time of dosage, inhalation technique quality, medication release, and behavioral patterns). This equips clinicians with the objective metrics strictly required to justify and bill for RPM/RTM services.
The FindAir ecosystem eliminates one of the greatest adoption barriers in US respiratory telehealth: the need to change a patient’s prescribed medication.
The design of the FindAir ONE add-ons covers more than 90% of globally utilized inhaler formats. This means RPM providers can offer monitoring to virtually any patient, without disrupting their current prescriptions or requiring physicians to alter their prescribing habits.
FindAir enters the US as a mature, market-verified technology partner. To date, the company has delivered over 14,000 smart medical devices and collaborated with nearly 80 institutional clients.
Beyond the RPM market, FindAir has built a strong position as a partner for the pharmaceutical sector (anchored by a multi-year agreement with a global pharma corporation) and clinical research organizations (CROs). The new US FDA clearance complements a robust European portfolio of 7 medical devices already CE-marked under the rigorous MDR standard.
Securing FDA 510(k) clearance for FindAir ONE for pMDI 1.2 sends a clear signal to US RPM and RTM platforms that they are gaining a partner whose technology has successfully cleared a crucial US regulatory pathway. We offer a plug-and-play IoT and data analytics infrastructure that enables the immediate onboarding of respiratory patients into existing reimbursement programs. Backed by our commercial track record in Europe and secured R&D funding for the coming years, we can focus our efforts in the US market entirely on forging partnerships and driving technology adoption within connected respiratory care.
Tomasz Mikosz, CEO of FindAir
FindAir is a provider of advanced connected medication-data infrastructure based on IoT devices for the respiratory care sector. Its flagship line of FindAir ONE products transforms traditional inhalers into smart, connected medical devices without affecting the medication or the course of therapy.
The ecosystem supports remote patient monitoring platforms (RPM/RTM), healthcare systems, and pharmaceutical companies worldwide.
24.06.2026.
