Devyser receives IVDR approval for post-transplant monitoring software
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Devyser has received IVDR approval for Advyser Solid organs, its software for the post-transplant product One Lambda Devyser Accept cfDNA. This is Devyser’s first European approval for post-transplant monitoring software under the new, more comprehensive IVD regulation that came into force in May 2022, and it confirms Devyser software meets the established safety, efficacy, and quality requirements.
"Achieving IVDR-certification for our software demonstrates Devyser’s commitment to pioneering genetic testing. This approval is another confirmation of our strong regulatory expertise and testament to the high quality, safety, and compliance of Devyser products," says CEO Fredrik Alpsten. "We are confident this approval will further enhance the growth potential of our transplantation products."
Advyser Solid organs is an IVD software for monitoring donor-derived cell-free DNA (dd-cfDNA) in patients following kidney transplantation. The software is intended for use with One Lambda Devyser Accept cfDNA, a novel NGS test for detecting dd-cfDNA in blood samples from kidney transplant patients. The assay received IVDR approval in 2023.
The product mentioned is CE-IVD marketed but not FDA-cleared. Availability in each country depends on local regulatory marketing authorization status. Please consult your local sales representative for details.