May 22,2023

Beta Bionics Announces FDA Clearance and Commercialization of the iLet Bionic Pancreas

Beta Bionics, Inc. — a medical technology company focused on diabetes — announces FDA 510(k) clearance and the commercial launch of the iLet Bionic Pancreas. The iLet is the first and only automated insulin-delivery system that does not require carb counting and fully automates 100% of all user insulin doses. The only input that is required to get started is the user’s weight. The iLet is paired with the Dexcom G6 Continuous Glucose Monitoring System.

PRODUCT

#closed loop

#cgm

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May 23,2023

New App From January.ai is an AI-Powered Health Coach, Uses Generative AI to Predict Blood Sugar Response to 32MM+ Foods

Precision health tech company, January AI, releases a new generative AI-enabled app that estimates and predicts individuals’ glucose response to 32 million foods, even when members are not wearing a continuous glucose monitor (CGM). Unlike a normal CGM, January AI predicts how food will impact a person's blood sugar, beyond only reporting what’s happened. “With January AI, members enter foods they are considering eating, and the predictive AI model will tell them what it will do to their blood sugar. It helps them make better decisions about what they’re about to put into their body, kind of like having an AI nutritionist in your pocket to let you know whether you should order'' said Noosheen Hashemi, who co-founded January AI in 2016 with Stanford University’s Director of Genomics, Dr. Michael Snyder, PhD. January AI is available now at app.january.ai for $288 for the first month ($28 monthly membership fee after).

PRODUCT

#mobile app

#cgm

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May 24,2023

Ypsomed doubles profits and confirms outlook

Ypsomed's consolidated sales were reported as CHF 497.5 million in the 2022/23 financial year (previous year: CHF 464.8 million). Ypsomed expects sales growth of the continuing business in the 2023/24 financial year of approximately 25%. At the EBIT level, Ypsomed confirms the outlook and expects an operating result of at least CHF 90 million. In the Ypsomed Diabetes Care segment, a decline in sales of 7.4% to CHF 173.5 million (previous year: CHF 187.5 million) was recorded for the financial year 2022/23. The main reason for this decline was the divestment of DiaExpert. Growth of 13.3% was achieved in the continuing business areas.

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May 18,2023

MedOne Launches Dario's Digital Health Solution to Help Members Improve Health with a Personalized Support

DarioHealth and MedOne Pharmacy Benefit Solutions announce a new agreement to integrate Dario's suite of digital health solutions as a complement to MedOne's digital diabetes solution, the Diabetes Care Path. The new arrangement will enhance the patient-facing support services for diabetic patients while the MedOne clinical team focuses on interventions with prescribers to optimize treatment plans. Members who are currently users of the PBM's Diabetes Care Path will be eligible to enroll in Dario's digital health solution effective June 1, 2023. Post-launch, Dario's solutions will be an integral part of the PBM enhanced diabetic management to their existing and future member populations. The agreement originated through Dario's previously announced strategic collaboration with Sanofi US ("Sanofi"), representing a major milestone achievement one year into the agreement.

COLLABORATION PARTNERSHIP

#institution

#mobile app

#dtx

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May 18,2023

Results from LifeScan's Study Showing People with Type 2 Diabetes Achieved Clinically Significant Improved Glycemic Control with One to Two Blood Glucose Checks Per Day Using SBGM and Mobile App

LifeScan announced that results from the study of real-world evidence Sustained Improvements in Readings In-Range Using an Advanced Bluetooth® Connected Blood Glucose Meter and a Mobile Diabetes App: Real-World Evidence from more than 55,000 People with Diabetes have been published in the peer-reviewed journal Diabetes Therapy. Using real-world data from more than 55,000 people with diabetes (PWD), this study aimed to understand if using the OneTouch Reveal® (OTR) mobile app with the OneTouch Verio Reflect® (OTVR) meter – synced via Bluetooth® wireless technology – could support sustained glycemic improvements for 180 days in people with type 1 diabetes (PwT1D) or type 2 diabetes (PwT2D). The real-world data demonstrated that PwT2D saw sustained, clinically significant improvements when engaging in just one to two OTR mobile app sessions per week, and performing one to two OTVR meter checks per day, over 180 days (n=3,563), including: Improved glucose readings in range in PwT2D by +12.0 percentage points; and Reduced hyperglycemic readings (>180 mg/dL) by -12.2 percentage points in PwT2D.

CLINICAL STUDY

#bgm

#mobile app

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May 19,2023

FDA Clears New Insulin Pump and Algorithm-Based Software to Support Enhanced Automatic Insulin Delivery

The U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system called the iLet Bionic Pancreas. This new automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery. The iLet Bionic Pancreas uses an adaptive closed-loop algorithm that is initialized only with a user's body weight and requires no additional insulin dosing parameters. This adaptive algorithm removes the need to manually adjust insulin pump therapy settings and variables as is needed with conventional pump therapy and is easier to initiate than other available AID systems.

REGULATORY FDA

#closed loop

#insulin pump

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May 04,2023

Roche Diabetes Care Sharpens Focus on Indian Market

Roche Diabetes Care India (RDC India) today announced that their blood glucose monitoring device ‘Accu-Chek Active’ is now manufactured in India. This move is a part of the company's strategy to improve access to diabetes care and meet the growing needs of the Indian market in collaboration with their manufacturing partner Sanmina-SCI India Pvt. Ltd. and assembly & distribution partner Parekh Integrated Services Pvt. Ltd.

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May 17,2023

Can Software Be The Solution To The Insulin War So Many Are Facing?

Robby Booth serves as Glytec’s Chief Strategy and Research Officer has discussed the concepts on how an insulin management software such as Glytec can help with the issues arising from an increasing number of people with diabetes and managing the disease.

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May 18,2023

U-Haul, Quartz Health Solutions, and 70+ Other Major Payers Partner with Virta Health to Fight Back Against Obesity Epidemic

Type 2 diabetes reversal leader Virta Health reported substantial growth of its obesity solution over the last three years. Today, the company partners with more than 70 employers and insurers—such as U-Haul and Quartz—that offer Virta’s provider-led weight loss solution in addition to diabetes reversal. Since expanding to address prediabetes and obesity in 2020, demand has accelerated. Currently, 20% of customers offer Virta’s weight loss solution, and 15% of Virta members are being treated specifically for obesity.

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Mar 17,2021

Amalgam Rx Appoints Medicare COO Jennifer Main as Chief Operating Officer and Chief Financial Officer

Amalgam Rx, Inc., the leader in connecting healthcare providers and life sciences companies through a SaaS-enabled digital marketplace and product platform, is announcing the appointment of Jennifer Main as chief operating officer (COO) and chief financial officer (CFO).

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