Swiss healthcare firm Roche has secured CE mark approval for its Accu Chek Solo micropump, a small, tube-free insulin delivery system.
The Accu-Chek Solo micropump offers users the choice to bolus directly from the pump or from the fully-functional handheld as well as to detach and re-attach the pump without wasting insulin.
The firm intends to start the pilot commercialization phase for its advanced insulin delivery system in Austria, Poland, Switzerland and the UK.
Roche is also carrying out a clinical study for the system in various European countries.
The Accu-Chek Solo system enables convenience and personalization in insulin pump therapy, helping in effective diabetes management.
The system provides the functionalities of a traditional insulin pump, in addition to the technological advancement of tube-free insulin delivery.
It includes two parts such as small, lightweight and semi-disposable insulin micropump, and fully-featured remote control incorporating blood glucose monitoring and bolus advice.
The system offers bolus insulin dosing both from the remote control or directly from the pump. It also provides option to detach and re-attach the pump without wasting insulin.
The system can also be connected to Roche Diabetes Care’s digital solutions such as the Accu-Chek Smart Pix system, enabling to offer decision and therapy support at the doctor’s office.
Roche Diagnostics CEO Roland Diggelmann said: “This important milestone will enable us to further expand access to insulin pump therapy to those people with diabetes who can benefit most from this therapy option – so they can spend more time in their ideal target range and experience an improved quality of life.
“The new modular design of our Accu-Chek Solo micropump system responds to the needs of people with diabetes for more discretion and flexibility.”
Separately, Roche has also secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Elecsys cerebrospinal fluid (CSF) assays.
The FDA has provided the designation to Elecsys ß-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF in vitro diagnostic immunoassays.
The assays will be used for the measurement of the ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment impairment who are being evaluated for Alzheimer’s disease or other causes of dementia.