Aug 03,2023

DarioHealth to Report Second Quarter 2023 Results on Thursday, August 10th

DarioHealth today announced that it will release its financial results for the second quarter ended June 30, 2023, on Thursday, August 10, 2023, before 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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Aug 03,2023

Tandem Diabetes Care Announces Technology Access Program to Provide Customers with Purchase Pathway to the Tandem Mobi System

Tandem Diabetes Care today announced a limited time offer for its Tandem Choice technology access program. This program provides new and renewing, eligible t:slim X2 Insulin Pump (t:slim X2) customers in the United States a pathway to ownership of the Tandem Mobi System (Tandem Mobi) for $199. The Tandem Mobi was recently cleared by the FDA to be used as a part of an automated insulin delivery system and a limited launch is expected to begin later this year with general availability in early 2024. Less than half the size of the t:slim X2 pump, Tandem Mobi offers control from an iOS mobile app and features an on-pump button that provides an alternative option to phone control for bolusing insulin.

PRODUCT

#insulin pump

#closed loop

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Aug 03,2023

Tandem Diabetes Care Announces Second Quarter 2023 Financial Results and Updated Full Year 2023 Financial Guidance

Tandem Diabetes Care today reported its financial results for the quarter ended June 30, 2023 and updated its financial guidance for the year ending December 31, 2023. The highlights from the company in the Q2 2023 refers to the U.S. launch of Tandem Source, a data management application designed to be a centralized digital ecosystem for customers and healthcare providers worldwide, as well as the FDA clearance for Tandem Mobi, the world’s smallest durable insulin delivery system. In September 2022, the Company began offering the Tandem Choice Program (Tandem Choice) to eligible t:slim X2 customers to provide a pathway to ownership of its newest hardware platform, Tandem Mobi, for a fee when available. GAAP gross profit was reported as $101.7 million, compared to $101.9 million. GAAP operating loss totaled $38.8 million, or negative 20 percent of sales, compared to operating loss of $12.2 million, or negative 6 percent of sales.

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Aug 03,2023

Smart Insulin Pens Market Size to Exceed USD 90.1 Mn by 2031 with CAGR of 11.2%: TMR Study

The global smart insulin pens market was valued at USD 31.2 Mn in 2021 and is projected to expand at a CAGR of 11.2% from 2022 to 2031. Growth in the market segment was attributed to the increase in adoption of technology in the management of diabetes and Integration of monitoring and therapeutic features to help detect blood glucose level and calculate insulin dose.

#insulin pen

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Aug 02,2023

Dario Introduces GLP-1 Behavior Change Program to Help Achieve Weight Loss Goals and Better Overall Health Outcomes

DarioHealth announced a new program today to deliver tailored behavior change support for individuals using GLP-1s and other anti-obesity drugs. The new program will help members realize the transformational power of these new medications while improving overall health and potentially help Dario's partners gain better insights on the impact across their populations. Consumers are driving a surge in demand for GLP-1s and employers and payers are working to solve for access with a limited understanding of broader clinical and financial implications. The company highlighted in the press release that the billions of data insights from Dario's decade of direct-to-consumer experience are used to drive highly personalized journeys focused on driving healthier lifestyle behaviors, and the new GLP-1 program builds on this approach to deliver long-term behavior change. Members will also have access to Dario's new Medication Cabinet, a digital tool developed through collaboration with the Company's strategic partner, Sanofi US, that allows members to track their medication adherence.

PRODUCT

#coaching

#mobile app

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Aug 02,2023

British Columbia expands public coverage of type 1 diabetes technologies to include a flash glucose monitoring device

The Government of British Columbia announced yesterday that the FreeStyle Libre, a flash glucose monitoring (Flash GM) device, will be covered by BC PharmaCare as a limited-coverage benefit for people living with type 1 diabetes (T1D) beginning August 1st 2023. Prior to this announcement, public coverage in British Columbia was limited to only the Dexcom G6 continuous glucose monitor (CGM). In British Columbia, it is estimated that 34,000 people live with T1D. Use of devices like Flash GMs have been shown to reduce hospitalizations and the risk of longer-term complications for its users. Through its #AccessForAll advocacy campaign, JDRF Canada has been working to help make a variety of T1D technologies affordable and accessible for all Canadians living with the disease.

PRODUCT

#reimbursement

#cgm

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Aug 01,2023

Diabetic Retinopathy Screening at the Point of Care (DR SPOC): detecting undiagnosed and vision-threatening retinopathy by integrating portable technologies within existing services

The aim of this study was to determine the prevalence of diabetic retinopathy (DR) in a low socioeconomic region of a high-income country, as well as determine the diagnostic utility of point-of-care screening for high-risk populations in tertiary care settings. a cross-sectional study of patients with diabetes attending foot ulcer or integrated care diabetes clinics at two Western Sydney hospitals (n=273). DR was assessed using portable, two-field, non-mydriatic fundus photography and combined electroretinogram/ pupillometry (ERG). With mydriatic photographs used as the reference standard, sensitivity and specificity of the devices were determined. Among 273 patients, 39.6% had any DR, while 15.8% had VTDR, of whom 59.3% and 62.8% were previously undiagnosed, respectively. Non-mydriatic photography demonstrated 20.2% sensitivity and 99.5% specificity for any DR, with a 56.7% screening failure rate. Meanwhile, mydriatic photography produced high-quality images with a 7.6% failure rate.

CLINICAL STUDY
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Aug 01,2023

Artificial intelligence for diabetic retinopathy in low-income and middle-income countries: a scoping review

Diabetic retinopathy (DR) is a leading cause of blindness globally. There is growing evidence to support the use of artificial intelligence (AI) in diabetic eye care, particularly for screening populations at risk of sight loss from DR in low-income and middle-income countries (LMICs) where resources are most stretched. However, implementation into clinical practice remains limited. The researchers conducted a scoping review to identify what AI tools have been used for DR in LMICs and to report their performance and relevant characteristics. The majority of studies focused on sensitivity and specificity only and there was limited information on cost, regulatory approvals and whether the use of AI improved health outcomes. Further research that goes beyond reporting sensitivities and specificities is needed prior to wider implementation.

CLINICAL STUDY
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Aug 18,2023

Diabetes: M Platform CE Certified as Class I Group of Medical Devices

Sirma Medical Systems' Diabetes: M platform receives CE certification and complies with EU Directive 93/42/EEC and EU Regulation 2017/745 for medical devices, ensuring safety and quality standards.

REGULATORY CE MARK

#mobile app

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Aug 18,2023

Sirma Medical Systems Receives ISO 13485:2016 Certificate for Quality Control Management

Sirma Medical Systems, creator of Diabetes: M app, receives ISO 13485:2016 certificate from Lloyd's Register, confirming compliance with medical software regulations and ensuring high-quality and safe products and services.

PRODUCT

#mobile app

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