Oct 23,2023 TOP STORY

Insulet Announces FDA 510(k) Clearance of the Omnipod® 5 App for iPhone

Insulet announced it has received FDA 510(k) clearance for the Omnipod 5 App for iPhone, making the Company eligible to offer a tubeless automated insulin delivery (AID) system with full control from a compatible Android and iOS smartphone. Since its full commercial launch in August 2022 in the United States, the Omnipod 5 Automated Insulin Delivery System has included the option for smartphone control for customers using compatible Android devices. With today’s announcement, the Omnipod 5 Pod will soon be controllable from a compatible iPhone. The Omnipod 5 App for iPhone will launch first with the Dexcom G6 Continuous Glucose Monitoring System integration, with a full market release in 2024.

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#insulin pump

#closed loop

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Nov 30,2021

metaMe Health Receives FDA Clearance for Regulora®, the First FDA-authorized Treatment Specifically for Abdominal Pain Due to Irritable Bowel Syndrome (IBS)

metaMe Health, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for Regulora®, the first FDA-authorized treatment of any kind specifically for abdominal pain associated with irritable bowel syndrome (IBS) in adults. Regulora® is a prescription Digital Therapeutic (PDT) that is self-administered through an Apple or Android smartphone and provides behavioral therapy based on Gut-Directed Hypnotherapy (GDH) through a convenient smartphone app that can be used at home. GDH helps patients with their IBS symptoms by promoting healthier control of digestive tract function and delivering therapy designed to influence pain sensation

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#mobile app

#pdt

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Sep 07,2023

alveoair® has received U.S. FDA clearance, marking a significant advancement in respiratory care

alveofit® (Roundworks Technologies Private Limited) is thrilled to announce that its product, alveoair® spirometer, has earned U.S. FDA clearance for distribution in the United States. Specializing in digital therapeutics for respiratory care, the company is committed to delivering affordable and interoperable lung health solutions. This U.S. FDA approval, coupled with strategic partnerships like the one with AstraZeneca, positions alveofit® for broader international expansion, particularly in the U.S. and emerging economies. Dr. Anil Kukreja, VP of Medical Affairs and Regulatory at AstraZeneca Pharma India, praised the FDA clearance as a milestone, highlighting alveofit's role in optimized diagnosis and management of lung disorders such as asthma and COPD.

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#connected device

#spirometer

#mobile app

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Aug 23,2023

Welldoc Receives 11th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar

Welldoc today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar . This clearance immediately follows Welldoc’s 10th 510(k) clearance announcement earlier this month, solidifying the company’s continued leadership in chronic care innovation. Welldoc’s latest 510(k) enables BlueStar to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. This feature enhances BlueStar’s existing digital coaching capabilities, which guide dietary and lifestyle decisions and assist individuals in self-managing their diabetes.

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#mobile app

#cgm

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Aug 15,2023

Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar

Welldoc today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management. This 10th 510(k) clearance enables BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations. This enhanced functionality will be made available commercially in 2024.

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#mobile app

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Aug 23,2023

Welldoc Receives 11th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar

Welldoc today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar . This clearance immediately follows Welldoc’s 10th 510(k) clearance announcement earlier this month. Welldoc’s latest 510(k) enables BlueStar to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. This feature enhances BlueStar’s existing digital coaching capabilities, which guide dietary and lifestyle decisions and assist individuals in self-managing their diabetes.

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#mobile app

#connected device

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Aug 15,2023

Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar

Welldoc today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management. This 10th 510(k) clearance enables BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations. This enhanced functionality will be made available commercially in 2024.

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#mobile app

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Aug 15,2023

FDA Grants Breakthrough Device Designation To Tempus’ HLA-LOH Companion Diagnostic Test

Tempus today announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough Device Designation for its HLA-LOH assay as a companion diagnostic (CDx) test. The test uses a machine learning model to analyze sequence data produced by Tempus’ FDA-approved, next generation sequencing-based xT CDx assay. It is intended to identify cancer patients with solid tumors who may benefit from treatment with specific targeted therapies when a patient’s tumor has experienced allele-specific loss of heterozygosity (LOH) for specific human leukocyte antigen (HLA) Class I alleles.

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#cdx

#ml

#ai/software

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Jul 10,2023 TOP STORY

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

Better Therapeutics received FDA authorization for AspyreRx™, 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?.

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#pdt

#cbt

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Jul 10,2023

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

The FDA has authorized Better Therapeutics' AspyreRx, a prescription digital therapeutic (PDT) called BT-001, to provide cognitive behavioral therapy to adults with type 2 diabetes. AspyreRx, a smartphone-based intervention, demonstrated significant and sustained reductions in A1c levels in a clinical trial. The authorization paves the way for addressing the behavioral factors contributing to disease progression in T2D and potential expansion to other cardiometabolic conditions.

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#pdt

#mobile app

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