10 September 2015
NITID (optical coherence tomography and digital dermatoscope handheld device) – CE Mark approval received
- DermaLumics announces CE Mark certification of NITID
- DermaLumics and MedLumics are now ISO 9001:2008 & 13485:2012 certified
- DermaLumics is ready to launch its first product
Madrid, September 10, 2015. DermaLumics, a recently founded spin-off of optical tomography systems developer MedLumics, announces that NITID, its first skin diagnostic solution, received CE Mark approval in Europe. NITID employs platform technology developed by MedLumics, miniaturizing optical coherence tomography systems into a small chip through integrated optics. NITID is a breakthrough and cutting-edge diagnostic imaging solution for Dermatology that will provide doctors with exceptional results and ease of use, improving patient flow and bringing pathology analysis closer to the patient.
“The creation of DermaLumics and commercial introduction of NITID are key achievements that realize the value of our technology platform and that take us forward in our vision of becoming leaders of the optical coherence tomography market,” said Eduardo Margallo, President and CEO of MedLumics.
NITID combines three imaging modalities — a clinical camera, a digital dermatoscope and an optical coherence tomography system — in a truly portable device. This imaging device provides real data management that can be linked to a secure cloud platform, giving access to selected patient data and allowing users to share cases with other members of the clinical community worldwide. NITID supports the non-invasive diagnosis of skin pathologies using simultaneous acquisition of three imaging techniques for improved workflow and diagnostic accuracy.
In Europe, skin pathologies affect approximately one third of the population, and the non-melanoma incidence rate is increasing as a result of aging and increased sun exposure. Skin tumors are more common in fair-skinned population.
Simultaneous to the NITID’s CE Mark, DermaLumics and MedLumics have been ISO 9001 and ISO 13485 certified. This allows DermaLumics to launch NITID immediately across Europe. DermaLumics expects NITID to gain massive acceptance in the dermatologist community, because of expected savings in treatment costs and diagnosis time reductions. NITID is poised to become the worldwide benchmark in its market segment and will play a prominent role in hand-held and ultra-compact devices implementing advanced optical imaging techniques.
“The company originated out of a desire to improve the living standards of the population through the application of knowledge. It is our goal to ensure that our brand new OCT technology allows patients to receive enhanced diagnostics through high-resolution medical imaging and to provide enhanced medical care by minimizing risk, discomfort and morbidity associated to conventional biopsy or surgical operations.” says Miguel Eslava, General Manager of DermaLumics.
“Having received all required certifications allows us to ultimately provide the patient population with all the benefits that we believe NITID will bring to their lives” states Sebastian Montero, Chief Operations Officer of DermaLumics.
DermaLumics is a new medical device company focusing on the dermatology market. Being a spin-off of MedLumics, DermaLumics is committed to transforming progress in the science and technology of light into high-quality innovative products improving human living standards worldwide. By expanding the clinical indications for optical coherence tomography, through a new class of hand-held and ultra-compact devices, DermaLumics is to become a major player for this new diagnostic imaging technique.