REGENSBURG, Germany, March 29, 2023 — Lifespin GmbH, headquartered in Regensburg, Germany with offices in Boston, MA, announced today that it has obtained ISO13485:2016 certification for its proprietary A.I.-based metabolomics technology platform located in Regensburg.
“The ISO13485 certification is a very important milestone towards achieving market-readiness of our A.I.-based metabolomics platform for health diagnostics,” said Dr. Ali Tinazli, CEO of Lifespin GmbH. “This step will support and enable our first commercial product launch, which is planned for later this year, and other products to be launched thereafter.”
Lifespin is building a highly scalable, automated diagnostics technology platform based on digitized metabolomic data, to be used in a variety of human health, diagnostics, disease management, as well as pharmaceutical research and development. Lifespin has built one of the largest and most comprehensive databases of metabolic health profiles across healthy and diseased individuals covering multiple age and biological sex groups as well as specific diseases in neurology, oncology, and inflammation.
“Lifespin’s proprietary technology merges biology, deep data, artificial intelligence, and cloud technologies in a unique way, potentially opening the door for digital metabolic analysis to emerge as a future gold standard to help grow the field of precision diagnostics, and bring about new diagnostic products, where none exist today,” further stated Lifespin’s CEO, Dr. Ali Tinazli. “These may include products focused on neurological diseases, along with applications in precision drug monitoring for clinical, pharmaceutical and research settings; and precision nutrition for diabetes, obesity, dietary and lifestyle interventions.”
“The successful certification is a testimony to our commitment to quality and safety and demonstrates our ability to combine innovative approaches with established regulatory standards. We are proud of our team’s hard work and dedication in achieving this milestone.” said Dr. Roland Geyer, COO at Lifespin.
Lifespin’s products and services offered to-date are for Research Use Only (RUO) and are not for use in diagnostics. Current developments in general health testing, oncology, and neurology yielding first regulated products in human diagnostics are expected for 2023.
Dr. Ali Tinazli, CEO, email@example.com , +1 310-467-1112 and +49-160-257-3458
David Paine, Public Relations, PaineLab, firstname.lastname@example.org, +1 949-233-0050