Jan 26,2023

Tidepool’s automated insulin dosing app for type 1 diabetes gets FDA approval

Tidepool’s automated insulin dosing app has been approved by the US Food and Drug Administration (FDA) to help those who are six years and older manage their type 1 diabetes. Tidepool is a nonprofit organisation and Tidepool Loop is the first app of its kind to receive clearance from the FDA, as well as the first to enable insulin delivery from a compatible Apple watch. Tidepool Loop’s algorithm technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller-enabled pumps to automatically increase, decrease and suspend delivery of basal insulin to the patient based on iCGM readings and predicted glucose values.

REGULATORY FDA

#closed loop

#mobile app

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Jan 27,2023

Nemaura Medical garners U.S.-based purchase order for glucose sensors

Nemaura Medical announced that it received a purchase order for 5,000 proBEAT glucose sensor subscriptions. HealthFleet, a U.S.-based telehealth provider, made the purchase order. It consists of 75,000 proBEAT glucose sensors over an initial five-month period. Nemaura values the deal at $500,000 in revenue, while HealthFleet possesses the option to increase volumes based on customer response.

PRODUCT

#cgm

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Jan 27,2023

US FDA approves Abbott’s Proclaim XR SCS system to treat Diabetic Peripheral Neuropathy

The US Food and Drug Administration (FDA) has granted approval to Abbott’s Proclaim XR spinal cord stimulation (SCS) system for the treatment of painful diabetic peripheral neuropathy (DPN). The Proclaim XR SCS system can offer DPN patients pain relief, as they often require alternatives to traditional oral medication treatments. After completion of a minimally invasive trial, patients will be implanted with the Proclaim XR SCS device. They will then be able to control their therapy through an Apple device.

REGULATORY FDA
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Jan 30,2023

Study backs digital diabetes program from Vida Health

San Francisco-based Vida Health published an article in JMIR Formative Research. Results from 1,128 participants demonstrated dramatic improvements in glycemic control. It also highlighted an important relationship between the improved management of depression and diabetes. Participants enrolled in Vida’s interactive digital health diabetes management program. The company designed it to enable members to manage both physical and mental health.

CLINICAL STUDY

#mobile app

#coaching

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Jan 31,2023

Nemaura Medical Announces Closing of Approximately $8.4 Million Registered Direct Offering and Concurrent Private Placement

Nemaura Medical announced the close of its previously announced registered direct offering with two healthcare-focused U.S. institutional investors to sell 4,796,206 shares of its common stock and warrants to purchase up to 4,796,206 Shares, in a concurrent private placement.The aggregate gross proceeds from the Registered Direct Offering and the concurrent Private Placement were approximately $8.4 million before deducting placement agent fees and other estimated offering expenses.

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Jan 31,2023

Study Results Published Sustained Clinically Significant Improvements in Over 144,000 People with Diabetes Using a LifeScan's Smart Blood Glucose Meter and Mobile App

The real-world data provides insights into improved glycemic metrics among people with diabetes using a Bluetooth connected BGM together with a diabetes management digital app - in this study, patients used the OneTouch Verio Flex® meter and OneTouch Reveal® app. The retrospective analysis showed that, overall, people with diabetes with at least 180 readings within the 180-day timeframe using the OneTouch Reveal® app with the OneTouch Verio Flex® meter experienced better glycemic control, improving glucose readings in range (70-180 mg/dL) by +6.1 percentage points in T1D, and +11.9 percentage points in T2Ds

CLINICAL STUDY

#bgm

#mobile app

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Jan 31,2023

The American Diabetes Association Announces 2023 Pathway to Stop Diabetes Grant Recipients

Today, the American Diabetes Association® (ADA) announced the two winners of the Pathway to Stop Diabetes® (Pathway) grants, a five-year grant to support breakthroughs in translational science, clinical science, technology, care, and potential cures in the field of diabetes. The Pathway program provides funding and support not only for research, but for promising young innovators who are sparking momentum to benefit diabetes patient care. The ADA is proud to support these individuals and their potential to change the face of diabetes care since 2014.

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Feb 01,2023

One Drop Named to the New York Digital Health 100

One Drop, a leader in precision health solutions for people living with chronic conditions worldwide, today announced that it has been named to the New York Digital Health 100 (DH100), a recognition that highlights the most exciting and innovative startups in the New York region, for the second consecutive year.

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Feb 02,2023

Postive phase 2 clinical trial results from NovioSense

NovioSense BV, the venture capital-backed clinical stage medical device company, today announced positive data from its NLNSGS2017-02 Phase 2 tear glucose sensor study. The NovioSense Glucose Sensor is a device that, when placed in the lower eyelid, continuously measures glucose levels in the tear fluid of diabetic patients. The results of the six-patient clinical trial are presented in the American Chemical Society Journal Biomacromolecules.

CLINICAL STUDY
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Feb 02,2023

How Embecta started strong and what’s ahead for the BD diabetes spinoff

Ten months after spinning off from BD, Embecta CEO Dev Kurdikar lays out what the future holds for the diabetes technology company. When Embecta became a standalone company in April 2022, CFO Jake Elguicze said he felt it was “uniquely positioned.” As a pure-play diabetes technology developer, Embecta formed a U.S. partnership with automatic push-button fingerstick glucose reader developer Intuity Medical. It also has partnerships in China and France over different technologies. The company is also developing its own insulin patch pump for the type 2 diabetes market.

PRODUCT

#insulin pump

#bgm

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