Corsano Health B.V. is a health-tech company developing, producing and marketing medically certified continuous health monitoring devices. Having been involved in the wearable industry for over 30 yrs and in the first developments of smartwatch applications for wearables, Peter Stas and Aletta Stas recognised the potential of smartwatch applications for medical purposes. Since 2014, they have been involved in the development of the first generation of health monitoring Swiss smartwatches. Since then, they have continued to be active at the forefront of medical applications for wearables and are currently enrolled in various clinical trials. The set up of the new, dedicated company Corsano enables full focus on this dynamic and growing market segment.
The Corsano brandname is derived from in corpore sano (in a healthy body).
Its first product, the Corsano CardioWatch is an essential part of a cardiac arrhythmia screening system that can, by providing a simple and effective method for continuous monitoring of the user’s heart rhythm, help identify the risk of a heart attack in an early phase. In its most extended version, the system consists of a bracelet plus a dedicated app on the user’s smartphone. The system can assist the user with maintaining a healthy lifestyle by providing immediate feedback on activity, sleep and heart rhythm data. Furthermore, smart analytics produce relevant data for timely detection of heart rhythm anomalies.
Company achieved certification as a medical device manufacturer according to the ISO 13485 norm under the new MDR regulations in November 2021. In addition, the first product CardioWatch 287 achieved CE certification as a medical product under the new MDR regulation.
First customer orders have been placed by Philips, Preventicus, Basel University Hospital, Charite, Franciscus, Splendo (Duke health), Insightfull, PsysIQ and many more.
Dutch Heart Foundation awarded Corsano and RadboudMC a ~€1m development project to recognize cardiac arrest and alert emergency services (out of 15 parties). Corsano will develop a certified medical solution that can be sold in Europe and the USA to over 1M patients (includes device and subscription services). Planned clinical trials in 2nd half 2022 with up to seven academic hospitals will prepare evidence to apply for CE-MDR and FDA in 2023.
Corsano is also developing a mental health solution in collaboration with Philips and care organizations in The Netherlands. Multiple pilots are planned in Q2 2022, if successful leading to sales of CardioWatch 287 and subscription services to tens of thousands of care workers.
We aim to achieve certification of next generation bracelet in Q4 2022. This will not only include CE MDR but also FDA approval.
Breakthrough new standards in healthcare (telehealth) with scalable, reliable,
efficient, decentralized, and continuous monitoring of patients
To realise this, we are developing and manufacturing best-in-class remote vital health monitoring wearables that are both clinician and user friendly. We leverage strategic partners to develop, test and validate a medical wearable with reliable continuous measuring functions to detect and monitor heart, lung and mental diseases
Clinical accuracy is paramount for us. In addition to third parties’ algorithms, i.e. from Philips, we run our proprietary algorithms to realize superior data accuracy. Corsano technology has been clinically validated in major academic hospitals. The bracelet is manufactured under ISO 13485 and CE-MDR compliance. The process for FDA Clearance has started.
What Differentiates Corsano Health
Device and platform EU-MDR certified, FDA 510K Q4 2022. Validated and proven with clinical trial data. QMS enables to add sensors, algorithms to Medical platform. +2 years head start.
35 years experience, ergonomic product, choice of materials, craftsmanship, battery life of 8-15 days, ergonomic and aesthetic designs that stimulate continuous wear.
Supply chain wearables, deep relationships with suppliers, Swiss quality, agility to rapidly develop next generations.