FDA– tag –
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Cell Culture Technology
Synthego Highlights CRISPR’s Potential to Drastically Improve Cultivated Meat Production Efficiency
Synthego USA Overview Synthego emphasizes the transformative potential of CRISPR gene-editing technology in significantly enhancing the efficiency of cultivated meat production, addressing critical challenges like high costs and scalabil... -
Market Trends
TechRadar Hails ‘Diabetes Breakthrough’: FDA Approves Abbott’s World’s First Dual-Sensor CGM
TechRadar UK Overview TechRadar reported the FDA's approval of Abbott's Libre Duo 10 Day as a 'diabetes breakthrough.' This is the world's first dual-sensor Continuous Glucose Monitoring (CGM) system capable of simultaneously tracking bo... -
Market Trends
FDA Authorizes First Continuous Glucose-Ketone Monitoring Wearable for Diabetes Patients Aged 2 and Older: Libre Duo 10 Day
Patient Care Online USA Overview The FDA has authorized Abbott's Libre Duo 10 Day as the first continuous glucose-ketone monitoring system for diabetes patients aged 2 and older. This landmark approval significantly enhances patient safe... -
Market Trends
Abbott Wins FDA Nod for World’s First Dual Glucose-Ketone Sensor, Bolstering Diabetic Ketoacidosis Prevention
MDO Online USA Overview Abbott's Libre Duo 10 Day has received FDA authorization as the world's first Continuous Glucose Monitoring (CGM) system capable of continuously tracking both glucose and ketone levels. Developed to prevent diabet... -
Market Trends
FDA Approves World’s First Dual Glucose-Ketone Continuous Monitoring Wearable for Diabetes Patients: Early DKA Risk Detection Enabled
GIGAZINE Japan Overview GIGAZINE reports that the U.S. FDA has approved the world's first wearable device for continuous dual glucose and ketone monitoring in diabetes patients. This is Abbott's Libre Duo 10 Day, providing real-time data... -
Market Trends
FDA Clears First Continuous Glucose-Ketone Monitor: Abbott’s Libre Duo 10 Day Transforms Diabetes Care
Pharmacy Times USA Overview The FDA has authorized Abbott's Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged 2 and older with diabetes. This marks the first continuous ketone monitoring wearable in t... -
Market Trends
HME News Reports: Abbott Gains FDA Clearance for Dual Sensing Technology, Marking New Step in DKA Prevention
HME News USA Overview HME News reports Abbott has received FDA authorization for its Libre Duo 10 Day system, which continuously monitors both glucose and ketones. This biowearable is designed to alert patients to rising ketone levels, c... -
Market Trends
Abbott’s Libre Duo 10 Day System Authorized by FDA: First US Continuous Dual Glucose-Ketone Wearable Provides Early DKA Warning for Diabetes Patients Ages 2+
Abbott & U.S. Food and Drug Administration (FDA) USA Overview Abbott's "Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System" has received FDA authorization, making it the first device in the US to continuously track ketone ... -
New Technology
Roche’s Elecsys® pTau217 Blood Test Gains FDA Clearance, Enabling Alzheimer’s Amyloid Pathology Identification in Primary Care for Individuals Aged 55+
Roche (Press Release) USA Overview Roche has announced FDA clearance for its Elecsys® Phospho-Tau (217P) Plasma (pTau217) blood test, offering a single, blood-based option for clinicians in both primary and specialty care to identify Alz... -
Business Trends
Roche’s PATHWAY® HER2 and VENTANA® HER2 Dual ISH Companion Diagnostics Approved by FDA for ZIIHERA® Eligibility in HER2-Positive Metastatic Gastroesophageal Adenocarcinoma
BioSpace USA Overview Roche has received FDA approval for two companion diagnostic tests, PATHWAY® HER2 (4B5) and VENTANA® HER2 Dual ISH DNA Probe Cocktail, to identify patients with HER2-positive metastatic gastroesophageal adenocarcino...