Michelson Diagnostics, the leading provider of Optical Coherence Tomography (OCT) skin imaging systems, is proud to announce that it has been awarded CE Mark certification in Europe to MDR (Medical Device Regulation EU 2017/745) as a Class IIa medical device for its new VivoSight Dx Pro OCT system.
MDR certification is recognised as one of the most rigorous regulatory frameworks in the world. It demands rigorous clinical evaluation, robust quality management systems and comprehensive technical documentation. Michelson Diagnostics’ achievement reflects its continuous investment in innovation, new product development and operational excellence.
Expanding usage
Michelson Diagnostics’ VivoSight product is the leading commercially available OCT skin imaging system. It is in clinical use in many countries, having performed over 200,000 patient examinations and has contributed to over 700 peer-reviewed research publications.
VivoSight OCT imaging is increasingly being seen as a superior, lower cost, and non-invasive alternative to the use of invasive biopsy in the diagnosis of Basal Cell Carcinoma (BCC), the most common type of skin cancer.
The new certification under MDR expands the use of VivoSight OCT from diagnosing BCC non-invasively to help avoid skin biopsy, to include identifying the BCC subtype and accurately estimating tumour invasion depth, both of which are essential for determining the most effective treatment path for patients; along with monitoring of treatments. Additionally, VivoSight is now able to be used to help distinguish between Actinic Keratosis (AK), a benign but premalignant skin lesion, from more serious Squamous Cell Carcinoma (SCC) and other malignancies.
On receiving the new certification, Jon Holmes, Michelson Diagnostics’ founder and CEO commented “we are undoubtedly proud to have achieved MDR certification and most especially pleased at the expanded indications for use and recognition of additional areas of efficacy for VivoSight Dx Pro skin imaging. These result from wide ranging and extensive clinical trials conducted by clinicians in many countries. We are proud of the contribution we can make to improving and simplifying care for patients with skin cancer”.
Advancing Non-Invasive Diagnosis
OCT skin imaging has now been incorporated into pan-European consensus guidelines for BCC diagnosis and is increasingly featured in national clinical standards, including those of Germany and The Netherlands. Notably, research has demonstrated that using VivoSight in the diagnosis of Basal Cell Carcinoma can eliminate the need for 66% of diagnostic biopsies, while also improving the detection of residual and recurrent BCC during follow-up, compared with standard clinical and dermatoscopic assessment. It is estimated that more than 200,000 BCC sufferers have already benefited from VivoSight OCT scans to date.
