Certification status

Luscii products in relation to FocusCura spin-out and CE certification

Background

Luscii is an independent company that is a spin-out of FocusCura Groep B.V. (FocusCura), a Dutch leading healthcare innovation company since 2003. In order to be able to innovate more quickly in a focussed domain and to ensure Luscii’s ability to introduce it’s own medical device to the market as a software product with a CE class IIa certification under MDD, the team that was working on Luscii products in Amsterdam for years decided to formalize Luscii as a fully independent company on 1 December 2018. 

Product history

FocusCura (the predecessor of Luscii) offered different products. One of those products was a medical device which classified as a Medical Device Class I under MDD. This Device started under the name “ThuismeetApp”, later changed to “FocusCura cVitals” and finally changed to “Luscii” as part of spin-out as mentioned above. With the spin-out to Luscii, Luscii not only became an independent company, but also started rearchitecting its application landscape since there was no longer an interdependency with other products of FocusCura. Also Luscii wanted to increase its focus on supporting clinicians (where in the past also other people and market segments were supported). In order to make the product landscape simpler, as part of the new architecture, several features and functionalities were re-envisioned. Finally, this led to a new product architecture which is described in the following paragraph. 

Current products and architecture

Luscii’s focus is to support clinicians to manage their time efficiently and keeping high quality care. Following the re-architecture, Luscii now develops, manufactures and markets digital solutions with the predominant aim to improve the communication and data exchange between patients and clinicians by making the communication independent of time and place. In order to do so, Luscii offers two separate digital health solutions: 

  1. Luscii contact: a communication tool to connect patients and clinicians to facilitate encounters between a patient and clinician remotely and more frequently than face to face encounters. This product has features like messaging and video calling and access to data and content for involved patients and clinicians. This application does not qualify as a medical device under Directive 93/42/EEC (MDD) nor under Regulation (EU) 2017/745 (MDR). 
  2. Luscii vitals: a new developed cloud service, also referred to as “Clinical Engine”, that acts autonomously generating alerts on the basis of incoming data and creating prioritized lists of patients that require the attention of a clinician. This new product is brought to the market as an independent software module (API) that can be integrated into third party products to support clinicians in a remote care-monitoring service by enabling them to monitor a patient’s state of health. This new product is considered a medical device under Directive 93/42/EEC (MDD) as well as under Regulation (EU) 2017/745 (MDR).

Certification status of Clinical Engine

The current status of the certification of Luscii’s Clinical Engine is that it is in the process of CE-certification as a Medical Device class IIa under the Medical Device Directives. The audit for this certification is scheduled in Q4 2020. Luscii’s compliance team is supported by Deloitte Legal B.V.. As soon as the certification is completed, the website will be updated.  

If their are any questions on status of certification of both the situation before the re-architecture efforts after the spin-out of Luscii from FocusCura as well as after, please contact Luscii via the contact page in the top of the website menu.