EXINI news

EXINI received FDA clearance for aPROMISE in the United States

On July 27th, EXINI Diagnostics AB, was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its digital application, aPROMISE™. aPROMISE was developed to quantify and standardize assessments of PSMA PET/CT images and will support the use of PYLARIFY® (piflufolastat F 18) in the U.S. aPROMISE is a convenient software platform that offers quantitative analysis and standardized reporting of PSMA PET/CT image assessments.

“With FDA clearance of aPROMISE, EXINI continues on the path to improve clinical management of prostate cancer patients with innovative and clinically relevant imaging biomarkers.” Aseem Anand, Vice President and Site Manager of EXINI Diagnostics AB, Sweden.

aBSI is now available in United Kingdom

The EXINI devices, aBSI and EXINI bone, are now available in the United Kingdom again. EXINI Diagnostics has performed the necessary actions to be able to provide the devices to the UK customers after Brexit. QAdvis UK Ltd has been appointed as responsible person (UKRP) in the UK. Thereby we are able to continue to provide our innovative CE marked devices aBSI and EXINI bone to our UK customers.

EXINI Diagnostics AB has achieved MDR-certification

The new European Medical Device Regulation 2017/745 (MDR) which replaces the Medical Devices Directive (93/42/EEC) will be mandatory from May 25th 2021. EXINI Diagnostics has through hard work and dedication received our MDR-certificate through our Notified Body TÜV SÜD.

“We are proud to be certified for MDR and look forward to enhancing the care of cancer patients with digital AI-solutions”
Dr. Aseem Anand. Vice President EXINI Diagnostics AB.


EXINI® is a Registered Trademark.


The materials on this website are of a general, informational nature. The content does not purport to be exhaustive and should not be relied upon as a substitute or replacement for individual medical, technical or instructional advice on any specific matter. If you have a specific question, you are most welcome to address it to one of our representatives or through the appropriate e-mail. Links to other websites are for information only. We do not endorse or accept any responsibility or liability for the material on any website referred to or accessed through this website. All links to our website should go to the top-level page.