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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Aug 17,2023

Nemaura Medical Announces SFDA Approval of sugarBEAT®

Nemaura Medical, a medical technology company focused on developing and commercializing a daily disposable, wearable glucose sensor and supporting personalized lifestyle coaching programs, today announced SFDA (Saudi Food and Drug Authority) approval of sugarBEAT®, its non-invasive wearable glucose sensor. The news comes following over a year of liaisons with the SFDA through TPMENA, the Company’s licensee in the Middle East. The Company previously announced the receipt of a provisional purchase order for 1.7 million sensors and 17,000 devices from TPMENA. They will now work with its licensee to commence fulfilling this purchase order.

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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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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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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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Aug 09,2023 TOP STORY

Nerivio® CE mark indication expanded to preventive and acute treatment of migraine for adolescents and adults

Theranica, a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, today announced it received expanded CE mark approval under MDR European regulation for Nerivio® as dual-use therapy for both acute and preventive treatment of migraine for adults and adolescents. The CE mark expansion for Nerivio is a critical milestone to accelerate the availability of the novel, drug-free migraine device into the European market. Nerivio has been available with prescription in the USA since 2020, initially for acute treatment and since April this year also as a preventive treatment.

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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.

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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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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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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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