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.

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