Scarletred®Vision system now approved as CE Class 1m Medical Device
We are excited to announce that SCARLETRED has received a new EC declaration of conformity approving Scarletred®Vision as a physiological measuring system and a CE Class 1m medical device.
With this higher certification of the system, companies, medical professionals and patients can make broad use of the integrated tools for standardized and high quality photo documentation as well as for quantifiable measurements of skin changes.
What is the difference between CE class 1 and CE class 1m?
Class 1 medical devices have very basic functions and the lowest risk for the patient compared to higher classified medical devices. These devices can be self-certified by the manufacturer. CE Class 1m devices, such as Scarletred®Vision, however include in addition to the basic functions (CE class 1) also measurement functions (CE class 1m) which require a special certificate of conformity and production quality assurance, thus they are subject to a thorough regulatory and clinical validation process involving regular audits and ISO13485 quality management checks by a notified body. CE class 1m devices can typically measure physiological parameters or energy, substances delivered or removed from the body, and display their value in a unit of measurement. The best known example of a typical Class 1m medical device is a thermometer which is used for measurement of human skin temperature.
In contrast to a thermometer, the skin imaging software Scarletred®Vision is capable of measuring visual changes in the skin such as 2D/3D (area, length, width, circumference, depth, volume of a lesion/wound) erythema (SEV* and a*), lightness (L*), yellowness/blueness (b*), texture (Txt), deltaE (dE) as well as the individual typology angle (ITA°), the latter used to estimate the photo-type (Fitzpatrick I-VI) and changes in the skin tone of individuals.
How can the system be used in pre-clinical and clinical studies ?
Since obtaining the Class 1 market approval in 2015, Scarletred®Vision has been used already in more than 100 clinical studies by early technology adopters including leading multinational biopharma, biotech and cosmetics companies. Main clinical research applications are currently in Atopic dermatitis, Psoriasis vulgaris, Hidradenitis suppurativa, Rosacea, Acne vulgaris, Lentigo solaris, Radiodermatitis, Hyper-,and Hypo pigmentation, Cutaneous T-cell lymphoma, Actinic keratosis, Epidermolysis bullosa, chronic wounds, burning wounds, skin infections, skin prick testing, skin patch testing, mechanical stress, Blepharitis, Onychomycosis, Injection Site Reactions (ISR) and many more.
Objective digital documentation and measurement of visual skin skin parameters via Scarletred®Vision enables biopharma-, cosmetics- and medical companies to assess and validate treatment effects in studies in real time during or after the patient visit, but also remote in a hybrid or in a fully home based setting (central reading).
With the recently obtained higher CE Class 1m certification of the system, the clinically validated measurement tools are now also certified and can thus be also easier integrated in later stage clinical trials (Phase III) as well as in market research and clinical routine. Scarletred®Vision is supplied worldwide via flexible Software as a Service (SaaS) agreement direct to our business partners.
What is Software as a Service (SaaS)?
Software as a Service(SaaS) is a SCARLETRED software delivery model in which the Scarletred®Vision medical device system and optional required hardware and consumables are not licensed, but supplied via service level agreement to our partners including CROs. Hence our business partners do not pay for the software itself, instead it is rented and provided over a highly secured network where servers and data are hosted by SCARLETRED as a vendor. Data exchange and processing is carried out in a ICG-GCP compliant process in accordance with the European General Data Protection Regulation (GDPR) and the US Health Insurance Portability and Accountability Act (HIPAA). Besides ensuring system compatibility and real time data availability, SCARLETRED's flexible SaaS agreements enable easy up/down scaling of the system, which reduces time efforts/cost and significantly de-risks the projects of our partners.
We are looking forward to getting in touch with you to discuss your individual technology and SaaS needs.