Jul 20,2023

FDA clears automated insulin pump from Beta Bionics for type 1 diabetes

The FDA has cleared the Beta Bionics iLet ACE automated insulin pump and iLet dosing decision software for people aged 6 and above with type 1 diabetes. The iLet Bionic Pancreas, which pairs with Dexcom G6 CGM, uses an adaptive, closed-loop algorithm to determine and command insulin delivery, simplifying diabetes management. The system showed promising results in reducing HbA1c and improving the quality of life in trial participants. The company hopes the iLet will alleviate the burden of diabetes management and be a step towards a fully automated insulin dosing system.

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Jul 11,2023

Tandem Mobi, World’s Smallest Durable Insulin Delivery System, Receives FDA Clearance

Tandem Diabetes Care receives FDA clearance for the Tandem Mobi insulin pump for diabetes patients aged 6 and above. The Mobi is the world's smallest durable automated insulin delivery system, controllable via a mobile app. It will be offered with Control-IQ technology, providing automated insulin delivery and other features. Limited release expected in late 2023, full commercial availability planned in early 2024.

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Jul 10,2023

Better Therapeutics Receives FDA Authorization for AspyreRx™ to Treat Adults with Type 2 Diabetes

Better Therapeutics, Inc. today announced that the Food and Drug Administration (FDA) authorized AspyreRx™ (formerly BT-001), a prescription-only digital therapeutic (PDT) treatment indicated to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes (T2D). AspyreRx was reviewed through the FDA’s De Novo pathway and its authorization creates a new class of diabetes digital behavioral therapeutic devices. AspyreRx is expected to launch commercially in Q4 2023?. Frank Karbe, Chief Executive Officer at Better Therapeutics commented “This De Novo authorization also provides a foundation for potential future growth opportunities. Given cardiometabolic diseases share common underlying factors that contribute to their development and progression, we intend to expand our PDT platform to multiple related conditions in the future.”

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Jul 06,2023

MedRhythms Announces FDA Listing of InTandem™ (MR-001) to Improve Walking and Ambulation in Adults with Chronic Stroke

MedRhythms has announced that its neurorehabilitation system, MR-001, designed to improve walking and ambulation in adults with chronic stroke walking deficits, has been listed as a Class II medical device by the FDA. The system, now named InTandem™, uses Rhythmic Auditory Stimulation to synchronize the motor and auditory systems in the brain to improve mobility. The device received Breakthrough Device Designation in 2020 and completed a pivotal clinical trial earlier this year.

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Jun 22,2023

Beta Bionics Announces FDA Clearance for the use of a Prefilled Insulin Cartridge with the iLet Bionic Pancreas

Beta Bionics has received FDA clearance for compatibility with the Fiasp® Pumpcart® (insulin aspart) prefilled insulin cartridge with 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 – and will provide users the choice of three insulins – Novolog®, Humalog® and Fiasp® Pumpcart®.

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Jun 12,2023

Huma receives multi-condition US FDA 510(k) Class II regulatory clearance for its configurable SaMD disease management platform

Huma Therapeutics, a leading global digital health company, today announced that it has received U.S. Food and Drug Administration (FDA) Class II clearance for its disease-agnostic Software as a Medical Device (SaMD) platform. Achieving Class II clearance means the platform is permitted to monitor patients of all ages with any condition - including paediatrics, and in pregnancy. The platform is also device-agnostic and can integrate with external third-party devices such as heart rate and blood sugar monitors, as well as smart inhalers, enhancing its capabilities and versatility.

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May 11,2023

Wellthy Therapeutics Announces Expansion into the United States - Completes FDA CFR Part 11, FDA CFR Part 820, and HIPAA Certification for Its Platform

Wellthy Therapeutics has completed FDA certifications, including FDA 21 CFR Part 11, FDA 21 CFR Part 820, and HIPAA certification, for its digital health platform. These certifications demonstrate the company's commitment to data security, privacy, quality, and regulatory compliance. With existing compliance with other international standards, Wellthy Therapeutics aims to provide globally compliant digital health solutions to improve patient outcomes and address unmet needs. The platform simplifies the ability for pharma, HUBs, providers, and health plans to launch and scale globally compliant digital health and SaMD solutions. Clients leverage the platform to configure and commercialize their own customized digital health and SaMD solutions that are deployable in a matter of weeks and at a fraction of traditional costs, while addressing their specific business goals and complex patient needs. Over 150,000 patients have benefitted from Wellthy Therapeutics' platform so far, highlighting the value that the company's platform brings, and its continued leadership in the clinical outcomes and patient engagement space.

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May 03,2023

HelloBetter received FDA Breakthrough Device Designation for Digital Therapeutic to treat Panic Disorder

HelloBetter, one of the world’s leading providers in developing and commercializing software-based medicines called prescription digital therapeutics (PDTx), has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its DTx HelloBetter Panic. Securing Breakthrough Device Designation represents the next step in HelloBetter’s long term strategy to access the US market, after the 2022 launch of the US-brand HelloGina.

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Mar 28,2023

DynamiCare Health Digital Therapeutic Receives FDA Breakthrough Device Designation for Treatment of Alcohol Use Disorder

DynamiCare Health's digital therapeutic, DCH-002, has received FDA Breakthrough Device Designation for the treatment of alcohol use disorder (AUD). The designation was based on a randomized control trial funded by the National Institutes of Health, demonstrating improved treatment retention and abstinence rates. DCH-002 combines a smartphone app, breathalyzer, and smart debit card, implementing a therapeutic methodology called contingency management. The digital therapeutic aims to increase access to care, offering a convenient and effective intervention without side effects. DynamiCare Health is conducting further trials, and the Breakthrough designation expedites the FDA's review process for marketing approval

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Mar 08,2023

DIGITAL THERAPEUTICS STARTUP RESPIREE™ GAINS US FDA CLEARANCE FOR ITS RS001 CARDIO-RESPIRATORY WEARABLE

Digital therapeutics startup, Respireetm, has received clearance from the US Food and Drug Administration (FDA) for its RS001 cardio-respiratory wearable, according to a press release. The wearable device measures respiration directly and can be used on patients suffering from cardio-pulmonary diseases such as chronic obstructive pulmonary disease (COPD) and congestive heart failure. The collected data is then transmitted to healthcare providers, who can use it to monitor patients remotely and provide real-time interventions. The FDA clearance is a significant milestone for Respireetm, allowing the company to market and distribute the RS001 wearable in the US. This approval highlights the growing trend towards remote patient monitoring and digital health solutions.

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