Better Therapeutics (Nasdaq:BTTX) announced today that it submitted a de novo classification request to the FDA for its BT-001 technology. San Francisco-based Better Therapeutics seeks marketing authorization for the BT-001 prescription digital therapeutic (PDT). It potentially represents the first-in-class PDT using cognitive behavioral therapy (CBT) to treat type 2 diabetes. Marketing initially would cover type […]
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JDRF launches Type 1 Diabetes Index simulation tool
JDRF announced today that it launched the Type 1 Diabetes Index (T1D Index) data simulation tool for measuring the impact of T1D around the globe. The tool measures the human and public health impact type 1 diabetes has in every country. JDRF said it addresses wide gaps in data about the incidence and impact of […]
Study backs automated insulin delivery system from Diabeloop
Diabeloop today announced 12-month data supporting its hybrid closed-loop DBLG1 automated insulin delivery system. Paris-based Diabeloop evaluated DBLG1 in a large, multi-country patient cohort. Results demonstrated constant improvement in time in range and time in hypoglycemia remaining significantly low. The company said in a news release that the results, combined with trust in its algorithm, […]
Medtronic, FDA warn on potential cybersecurity risk with MiniMed insulin pump
Medtronic (NYSE:MDT) issued an urgent medical device correction notice to warn of potential issues with some MiniMed automated insulin delivery systems. The notice — dated this month — covers the company’s MiniMed 600 series insulin pumps (MiniMed 630G and 670G). Affected devices also include the Guardian Link 3 transmitter, Contour Next Link 2.4 blood glucose […]
CISA warns on cybersecurity vulnerabilities for certain Baxter infusion pumps
The U.S. Cybersecurity and Infrastructure Security Agency (CISA) today issued a warning on some Baxter (NYSE:BAX) infusion pumps. Sigma and Baxter Spectrum infusion pumps are included in a CISA notice over remotely exploitable vulnerabilities. Those vulnerabilities include: missing description of sensitive data, use of externally controlled format string and missing authentication for critical functions. The […]
Virta Health diabetes reversal produces positive outcomes in 90-day study
Virta Health announced today that a partnership with U-Haul demonstrated positive outcomes from its type 2 diabetes reversal treatement. San Francisco-based Virta — launched in 2017 — aims to reverse type 2 diabetes. It designed its technology platform to enable personalized remote care. Its offerings include physician supervision, health coaches, an app and biomarker tracking […]
Study shows workplace productivity improvements with One Drop type 2 diabetes tech
One Drop today announced positive results from a trial of its digital health platform for people with type 2 diabetes. Employees using the One Drop digital diabetes management platform experienced significant productivity and functioning gains and were less likely to experience presenteeism at follow-up compared to control groups. One Drop’s platform uses AI to provide […]
Glytec, CPS collaborate on glycemic management support for pharmacy departments
Glytec announced today that CPS Solutions selected it to serve as an insulin management technology resource. Waltham, Massachusetts-based Glytec will serve as a resource for CPS’ more than 2,200 pharmacy professionals across more than 800 healthcare facilities nationwide. Through the collaboration, CPS client facilities can contract for Glytec’s eGlycemic Management System (eGMS) and Glytec’s technical […]
Hygieia appoints diabetes veteran Doug Lawrence as CEO
Hygieia — a developer of digital therapeutics for insulin therapy — announced today that it appointed Doug Lawrence as its CEO. Lawrence will take the corner office at Livonia, Michigan-based Hygieia with responsibilities for leading operations, development, and global growth of the company and its d-Nav insulin management program. The FDA-cleared d-Nav system autonomously adjusts […]
Nuvo, Sheba Medical Center develop AI-powered gestational diabetes management platform
Nuvo Group announced today that it completed the first phase of a collaboration agreement with Sheba Medical Center’s “Sheba BEYOND.” The first phase of the partnership included a pilot program centered around gestational diabetes management. The program shifted necessary non-stress tests (NSTs) to home-based, remote monitoring using Nuvo’s INVU rather than conducting traditional monitoring in […]