APAS Independence - ...
First Placement of APAS® Independence in a US Lab
Clever Culture Systems AG (CCS) has placed the first APAS® Independence instrument into a United States medical centre, which will act as a key opinion leader ahead of expected United States commercial market launch in 2019.
The APAS® technology remains the only FDA cleared instrument, indicated for use as a Class II medical device, following FDA clearance for the manual version, APAS® Compact in October 2016. To support commercialisation and sales in the US, a 510(k) is required to submit to the US FDA for the automated instrument, APAS® Independence. The Company will provide a progress update on the submission before the end of 2018.
Hennepin Healthcare System includes the Hennepin Healthcare Research Institute (HHRI) and the Hennepin County Medical Centre (HCMC), a 484-bed medical centre focused on delivering comprehensive medical service to the Minneapolis community. HCMC is a nationally recognised Level I Adult Trauma Centre and Level I Paediatric Trauma Centre and acute care hospital. HHS also maintains an integrated clinic system with primary care clinics located in Minneapolis and across Hennepin County. The HCMC Microbiology Laboratory provides a full range of services including all diagnosis of bacterial, viral, mycotic, and parasitic infections, including extensive testing and reporting or antimicrobial susceptibility results. Minneapolis is also a key hub of medical devices and medical innovation in the United States.
A Memorandum of Understanding has been executed between CCS and HHRI to formalise the collaboration. Training and commissioning of APAS® Independence will occur over the coming weeks and integration into the HHRI workflow is expected in early 2019. The intention that once fully operational, the Centre will become a North American centre of excellence for the APAS® Independence instrument. Dr. Glen Hansen, Director of Microbiology at HHRI has a reputation for innovation that improves patient outcomes and will lead the establishment of the Centre of Excellence for APAS®.
Dr Hansen stated: "This collaboration is another example of Hennepin Medical Centre and Hennepin Healthcare Research Institute, employing the latest technology to deliver quality and timely results to our customers. We expect this collaboration will further benefit our customers and their patients by bringing together our clinical expertise and the artificial intelligence of the APAS® Independence further enabling the microbiology laboratory in its delivery of accurate and timely resulting."
Date Published: 26th November 2018
Source article link: Clever Culture Systems
APAS Independence - The First