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iLet Bionic Pancreas for Type 1 Diabetes Patients and Genius endoscopy: FDA Clearance for Revolutionary AI Polyp Detection in Colonoscopies...
FDA Approval Unlocks iLet Bionic Pancreas for Type 1 Diabetes Patients
The FDA has granted clearance for the iLet Bionic Pancreas, designed for patients with type 1 diabetes. Developed by Beta Bionics, a US company, the device incorporates technology initially pioneered by researchers at Boston University. Functioning in tandem with a Bluetooth glucose monitor, the system administers personalized insulin doses at five-minute intervals. The dosage calculations consider present and historical glucose levels and the individual’s responses to prior insulin administrations. The origins of this technology are rooted in a personal narrative, with one of the researchers propelling its development driven by experiences caring for a son with type 1 diabetes.
Managing blood glucose levels in type 1 diabetes patients requires constant attention, presenting a year-round challenge. The persistent threat of dangerously low blood sugar levels, especially during sleep, adds complexity to the task. This obstacle, stemming from a researcher’s firsthand experiences caring for a son with type 1 diabetes during nightly challenges, served as the impetus for creating this technology. The recognition of these risks and the technology’s potential spurred its development.
The device, cleared for individuals aged six and above with type 1 diabetes, simplifies usage by requiring users to input their weight. The device then autonomously regulates blood glucose levels, continuously learning from the user’s data. Additionally, its compact design allows it to fit conveniently in a pocket or be attached to a strap or belt.
Genius endoscopy: FDA Clearance for Revolutionary AI Polyp Detection in Colonoscopies
Medtronic has received FDA clearance for its GI Genius endoscopy technology designed to identify suspicious lesions during routine colonoscopy. Compatible with any video colonoscope, the system can also analyze pre-recorded colonoscopies.
The company reports that the GI Genius module has shown a significant 14% absolute increase in adenoma detection rate (ADR) compared to standalone colonoscopy for both flat (42% increase) and polyploid (36% increase) lesions. This enhancement in accuracy aims to reduce the occurrence of interval cancers that may develop between colonoscopies.
The system functions by placing a green box over any suspected polyp in a colonoscopy video, providing physicians with a clear visual indicator to examine and better assess the identified area closely. This technology represents a valuable tool for improving diagnostic precision and reducing the risk of missed lesions during colonoscopies
