Mar 22,2024

DTA Responds to the Peterson Health Technology Institute’s Evaluation of Digital Diabetes Products

The Digital Therapeutics Alliance (DTA) has responded to a recently published report by PHTI to evaluate digital health technologies, and they express concerns about the report's framing and methodology. The report took a look at 8 digital diabetes management solution providers for type 2 diabetes patients, including DarioHealth, Omada Health, Vida Health, and Virta Health. While supporting PHTI's transparent approach, DTA suggests improvements such as including a broader range of products, utilizing real-world evidence in economic evaluations, and involving disease-specific experts in the analysis. DTA disagrees with some conclusions, and urges PHTI to enhance its evaluation approach to meet modern healthcare standards. They recommend more transparency, stakeholder involvement, and inclusivity in future reports.

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Mar 21,2024

DARIOHEALTH TO REPORT FOURTH QUARTER 2023 RESULTS ON THURSDAY, MARCH 28TH

 DarioHealth will release its financial results for the 4th quarter ended December 31, 2023, on Thursday, March 28th, 2024, before the market opens and will host a conference call and webcast at 8:30 am Eastern Time. Erez Raphael, Chief Executive Officer and Rick Anderson, President, will host the call.

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Mar 18,2024 TOP STORY

Sequel’s twiist™ Automated Insulin Delivery System Receives FDA 510(k) Clearance

Sequel Med Tech, a company developing insulin delivery technologies, announced its partner, DEKA Research & Development Corp., has received 510(k) clearance from the U.S. FDA for the twiist Automated Insulin Delivery (AID) system powered by Tidepool. The twiist AID system, which will be commercialized by Sequel Med Tech, LLC, is the first drug delivery system that directly measures the volume and flow of insulin delivered with every micro-dose. Cleared for people ages 6 and up with type 1 diabetes, the twiist AID system offers the capability to address each patient’s individual dosing needs. The twiist system incorporates FDA-cleared Tidepool Loop technology, which enables the system to automatically adjust insulin delivery based on CGM readings and predicted glucose levels.

REGULATORY FDA

#closed loop

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Mar 20,2024

Insulet Appoints Ana Maria Chadwick as Chief Financial Officer

Insulet Corporation announced that Ana Maria Chadwick has been appointed Executive Vice President, Chief Financial Officer and Treasurer, effective April 22, 2024. A talented finance executive with 30 years of experience propelling growth for top-tier global organizations, Ms. Chadwick is currently Executive Vice President and CFO of Pitney Bowes, where she has played an integral role in the company’s transformation from a 100-year-old mailing solutions operation into a technology-enabled growth business.

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Feb 28,2023

Verily slashes 15% of workforce

Alphabet healthcare and life science subsidiary Verily Life Sciences has informed employees in an email that it is laying off over 200 people amid a broader reorganization and strategy shift. Other layoffs are related to Verily taking full control of its Granular and Onduo joint ventures or redundancy with its new operating structure.

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Mar 12,2024

Welldoc Announces CE Mark Certification

Welldoc announced that its flagship BlueStar mobile app has received CE mark certification as a Class IIa medical device under the European Union Medical Device Regulation (EU-MDR). This enables the company and their strategic partners to advance digital health solutions in the EU, addressing chronic condition needs that are rising globally. The announcement builds upon Welldoc’s existing 11 FDA clearances for type 1 and type 2 diabetes management capabilities, including advanced insulin dosing calculators. This milestone underscores the company’s continued commitment to the highest standards of quality, while also demonstrating extensive leadership in AI-based digital health solutions. 

REGULATORY CE MARK

#mobile app

#coaching

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Mar 14,2024 TOP STORY

WebMD Health Services Announces Strategic Partnership with Verily's Onduo to Enhance Employee Health and Well-Being

WebMD Health Services announced a new partnership with Onduo, a virtual care management solution from Verily, an Alphabet precision health technology company. WebMD Health Services will integrate Onduo's virtual care solution into WebMD ONE, a comprehensive health and well-being platform. Onduo helps individuals living with chronic conditions, offering support for type 1 and type 2 diabetes, hypertension, healthy weight, and prediabetes. Together, participants will receive ongoing care support from a collaborative care team of Onduo health coaches, educators, registered dietitians, pharmacists and telemedicine physicians. "Onduo's care management programs complement WebMD's well-being programs and health coaching services, stepping in with timely support to promote care coordination between the member, Onduo Care Team and the member's primary or specialty care provider," said Bruce Foyt, WebMD Health Services Vice President, partnerships.

COLLABORATION PARTNERSHIP

#institution

#coaching

#telehealth

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Mar 12,2024

SAVINGS OFFER FOR THE EVERSENSE E3 CGM EXTENDED TO COVER UNLIMITED NUMBER OF SYSTEMS

Ascensia Diabetes Care and Senseonics Holdings have extended the Eversense Payment Assistance and Simple Savings (PASS) Program in the U.S., aimed at making the Eversense E3 CGM System more accessible. Eligible individuals will pay only $99 for an unlimited number of 6-month Eversense E3 systems, equivalent to an average monthly cost of $16.50 and a total out-of-pocket cost of less than $200 for each entire year of continuous glucose monitoring with Eversense E3, excluding the costs of insertion and removal. The program, initially launched in April 2022, has expanded its coverage to include a whole year of continuous glucose monitoring and more commercially insured people with diabetes. Eligibility requires a commercial insurance plan and meeting medical coverage criteria for CGM. Exclusions apply to government insurance and certain commercial insurance plans.

PRODUCT

#cgm

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Mar 07,2024 TOP STORY

Roche unveils new CGM tech with predictive AI, outlines diabetes strategy

Roche gave a presentation debuting its first continuous glucose monitor (CGM) offering that utilizes predictive AI. The company unveiled its Accu-Chek SmartGuide in an event at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Florence, Italy.  Julien Boisdron, Roche Diabetes Care’s chief medical officer, called it “a solution more than a CGM” during the event. Roche aims to bring the real-time CGM to both the type 1 and type 2 diabetes populations, including for those on insulin therapy. Users can share their data with healthcare professionals and it has a differentiating predictive algorithm included. Based on the CGM data of the person with diabetes, the system’s app shows where glucose levels might go in the next two hours at any given point in time. With the device still investigational, there is still plenty going into the development efforts at Roche. That includes the potential for connecting the CGM to insulin pumps, like other CGM makers have done.

PRODUCT

#cgm

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Mar 06,2024 TOP STORY

REAL-WORLD DATA SHOW ABBOTT'S FREESTYLE LIBRE® SYSTEMS AND GLP-1 MEDICINES WORK BETTER TOGETHER FOR PEOPLE WITH TYPE 2 DIABETES

Abbott announced new data showing that individuals with Type 2 diabetes using GLP-1 medicines alongside FreeStyle Libre technology experienced greater improvement in their HbA1c levels compared to those using GLP-1 medicines alone. GLP-1 medicines stimulate insulin release and aid weight loss in Type 2 diabetes management. The studies presented at ATTD revealed significant HbA1c improvements (-1.5% to -2.4%) after adding FreeStyle Libre technology to GLP-1 therapy, regardless of GLP-1 duration or insulin therapy. This combination enhances glycemic control and supports positive behavior changes by providing real-time glucose data.

CLINICAL STUDY

#cgm

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