CellaVision receives CE marking according to IVDR Class C for CellaVision® Bone Marrow Aspirate Application

On December 8, CellaVision announced an important milestone: its new CellaVision Bone Marrow Aspirate (BMA) Application has received CE marking approval as a Class C product under the European Union In Vitro Diagnostic Regulation (EU IVDR).

What IVDR Class C means

IVDR is the EU’s governing regulation that sets high requirements for the safety, performance, and quality of in vitro diagnostic devices. The IVDR device classification ranks from class A (lowest risk) to class D (highest risk). Class A products are based on self-certification, whereas Class B-D require a complete review by a notified body. Devices such as the CellaVision BMA Application which are intended to be used for screening, diagnosis, or staging of cancer should be classified as Class C devices.

Benefits for laboratories

The CE-marked CellaVision BMA Application offers laboratories a trusted and advanced solution for automating, standardizing, and simplifying the morphological examination of bone marrow aspirate.

“The certification demonstrates our dedicated quality efforts, as well as our ambition and commitment to be at the forefront of streamlining bone marrow morphology examination. Furthermore, this accomplishment exerts yet another testimony in our relentless effort to digitalize morphological cell analysis across hematology laboratories worldwide”, says Simon Østergaard, CEO at CellaVision.

How it fits into the lab workflow

The CellaVision BMA Application runs on the CellaVision DC-1 instrument using a 100X objective. The CellaVision DC-1 is a compact, high-quality image analysis instrument that has been CE marked and commercially available since 2019. It is supplied with the CellaVision Peripheral Blood Application as a standard feature.

By adding the CellaVision BMA Application to the CellaVision DC-1 instrument, laboratories can analyze and review both bone marrow and peripheral blood samples side by side. This supports more comprehensive assessments when abnormalities are detected in the blood or when a diagnosis with bone marrow involvement is suspected.

AI-powered analysis and remote review

The CellaVision BMA Application consists of the CellaVision BMA Analyzer Software and the CellaVision BMA Review Software. 

The advanced CellaVision BMA Analyzer Software automatically locates, pre-classifies, and stores bone marrow aspirate cells based on morphology using advanced AI-driven technology. Paired with the CellaVision BMA Review Software, users can securely access cell images and verify pre-classification results from any location, at any time.