The Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software have been approved by the U.S. Food and Drug Administration for use in type 1 diabetics six years of age and older.

United States: The US Food and Drug Administration (FDA) has approved a wearable, pocket-sized, automated insulin administration device that was first created in a lab at Boston University and is known as Bionic Pancreas. The Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software have been approved by the U.S. Food and Drug Administration for use in type 1 diabetics six years of age and older. The iLet Bionic Pancreas is a revolutionary system that combines these two devices with an integrated continuous glucose monitor (iCGM) that is compatible and FDA-cleared. An algorithm is used by the new automated insulin dosing (AID) device to decide when and how much insulin to deliver.

The approval is a huge achievement in two decades journey. An insulin infusion pump and algorithm-controlled dosing determination software is combined in the bionic pancreas. Damiano's kid, who was identified as having type 1 diabetes at the age of just 11 months, served as an inspiration for the development of the system. The iLet can give customized insulin doses every five minutes based on estimates of current and previous glucose levels and the body's response to previous insulin delivery when paired with a Bluetooth-enabled glucose monitor. The iLet, a device that is small enough to fit in a pocket or attach on a bra strap, helps patients of the 24/7 task of constantly monitoring their blood glucose levels and calculating their appropriate insulin dose with the assistance of their doctors. It is approved for the people aged six years and above with type 1 diabetes.

Basal or background insulin is the naturally occurring, low-frequency supply of insulin produced by the human pancreas. Patients with type 1 diabetes have inadequate insulin production from their bodies. All basal insulin doses are independently determined and ordered by the iLet Dosing Decision Software, which also determines, and orders correction doses of insulin based on information from an integrated continuous glucose monitor iCGM. iLet determines and commands meal doses of insulin based on meal announcements automatically.

According to the FDA Director of the FDA’s Center for Device and Radiological Health, Jeff Shuren "Today's action will provide the type 1 diabetes community with additional options and flexibilities for diabetes management and may help to broaden the reach of AID technology. The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance like diabetes through precision medicine approaches”

According to Damiano Founder and Executive Chairman at Beta Bionics and a Boston University college of engineering professor of biomedical engineering “This milestone is particularly poignant to me as the news of FDA clearance coincided with the 24th birthday of my son, David, who developed type 1 diabetes as an infant, just over 23 years ago,”

According to TechSci Research, the approval of bionic pancreas is expected to help people suffering from Type 1 Diabetes and have a positive impact in the treatment of a chronic disease.

Automated insulin delivery systems also known as closed-loop control systems, monitor a person's blood sugar levels using a continuous glucose monitor and use an insulin pump to automatically administer the hormone insulin as necessary. The bionic pancreas offers a more precise and automated method of managing diabetes compared to traditional methods that rely on manual insulin administration.

Advancements have been made in specific areas, such as cochlear implants for hearing loss, artificial hearts and pacemaker devices for heart failure, and artificial limbs controlled by neural interfaces for amputees and so on with kidney, liver and lungs. These technologies integrate electronic components or artificial materials with biological tissues to restore or enhance specific functions. It may boost innovation, increase investment on R&D, and promote economic expansion. A competitive market environment with expanded product offers and improvements in related technologies may result from the rising demand for bionic organs.

As Bionic Pancreas approved by FDA, the bionic pancreas can potentially increase the demand for such devices in the market. People with diabetes who are dissatisfied with current treatment options may be eager to adopt this new technology to simplify diabetes management and improve their overall well-being.