FDA– tag –
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FDA Approves Firmware Update for Dexcom G5 Mobile Continuous Glucose Monitoring System
FDA.gov USA Overview The U.S. FDA has approved minor design changes to the firmware installed on the transmitter component of the Dexcom G5 Mobile Continuous Glucose Monitoring System. Issued as a Premarket Approval (PMA) supplement, thi... -
Achaemenid LLC Receives FDA 510(k) Clearance for iNOS Intraoral Biosensor, Integrating Sleep Apnea Therapy with Continuous SpO2 Monitoring
Sleep Review Magazine USA Overview Achaemenid LLC has obtained FDA 510(k) clearance for its iNOS intraoral biosensor, a prescription device combining an oral appliance with an integrated pulse oximeter. Designed to reduce snoring and mil... -
Dexcom Secures FDA Authorization for Stelo Glucose Biosensor System, First OTC CGM for Non-Diabetic and Non-Insulin Using Individuals
Devices@FDA (Dexcom) USA Overview Dexcom, Inc. has received FDA authorization for its 'Stelo Glucose Biosensor System,' marking it as the first over-the-counter (OTC) integrated continuous glucose monitor (iCGM) specifically for individu... -
CAP Emphasizes Crucial Role of Rapid POCT in Combating STIs, Driving Efficient Care
The National Law Review USA Overview The College of American Pathologists (CAP) has published an article highlighting the significant benefits of point-of-care testing (POCT) for sexually transmitted infections (STIs), emphasizing its ro... -
Abbott Receives FDA Authorization for Libre Duo 10 Day: World’s First Dual Continuous Glucose and Ketone Monitoring System for Early DKA Warning
Medical Update Online (Abbott) USA Overview Abbott has secured FDA authorization for its Libre Duo 10 Day, the world's first dual continuous glucose and ketone monitoring (CGKM) system. This novel bio-wearable provides real-time glucose ... -
FDA Classifies Continuous Glucose Monitor Retrospective Data Analysis Software as Class I, 510(k) Exempt Medical Device
FDA.gov USA Overview The U.S. FDA has classified continuous glucose monitor retrospective data analysis software (Product Code PHV) as a Class I medical device, exempting it from 510(k) premarket notification. This software is intended t... -
FDA Approves Minor Firmware Design Changes for Dexcom G5 Mobile CGM System Transmitter Component
FDA.gov USA Overview The U.S. FDA has granted a Premarket Approval (PMA) supplement for minor design changes to the firmware installed on the transmitter component of the Dexcom G5 Mobile Continuous Glucose Monitoring System. This approv... -
FDA Clears Achaemenid LLC’s iNOS Intraoral Biosensor for Sleep Apnea Therapy and Continuous Monitoring
Sleep Review Magazine USA Overview The U.S. FDA has granted 510(k) clearance to Achaemenid LLC's iNOS, an intraoral biosensor designed for the treatment and monitoring of obstructive sleep apnea (OSA). This prescription medical device re... -
Ori Biotech Secures $120M, 10-Year Partnership for Automated Cell Therapy Manufacturing; Vyriad’s In Vivo CAR-T Clears IND
RegMedNet UK Overview Ori Biotech announced a 10-year, $120 million partnership with an undisclosed biopharma firm to automate cell therapy manufacturing using its IRO platform, aiming to improve patient access. Concurrently, Vyriad secu... -
Vertex Pharmaceuticals Initiates Phase I/II for Type 1 Diabetes Cell Therapy, Expands Renal Pipeline at Morgan Stanley Conference
MarketBeat USA Overview Vertex Pharmaceuticals unveiled its ambitious growth strategy beyond cystic fibrosis at the Morgan Stanley 24th Global Healthcare Conference, emphasizing its renal pipeline and a groundbreaking cell therapy progra...
