FDA– tag –
-
Orca Bio Boosts East Coast Manufacturing Capacity, Triples West Coast Workforce Ahead of Potential Orca-T® Launch
BioSpace USA Overview Orca Bio announced the expansion of its East Coast manufacturing capacity and a threefold increase in its West Coast manufacturing workforce, in anticipation of the potential launch of its flagship program, Orca-T®.... -
PAT Revolutionizes Biomanufacturing QA: Raman/NIR Spectroscopy and Inline Probes Enhance Real-Time Monitoring
Technology Networks UK Overview Process Analytical Technology (PAT) is transforming biomanufacturing quality assurance through real-time monitoring. PAT tools, including Raman and NIR spectroscopic sensors, inline probes, and chemometric... -
Raman Spectroscopy Outperforms NIR for Glucose/Lactate Monitoring in Bioprocess, Becomes Industry Standard
Technology Networks UK Overview Raman spectroscopy has demonstrated superior selectivity and predictive accuracy compared to Near-Infrared (NIR) spectroscopy for real-time monitoring of glucose and lactate in mammalian cell cultures. Thi... -
FDA Reclassifies SARS-CoV-2 POCT Devices to Class II, Easing Regulatory Burden for Rapid Diagnostics
GovInfo (Federal Register) USA Overview The U.S. FDA has issued a final rule, effective June 11, 2026, reclassifying simple point-of-care (POCT) devices for direct detection of SARS-CoV-2 viral targets to Class II (special controls). Thi... -
Precision and Provenance: Why Regulatory Approval and MARD Transparency Define the Future of Glucose Monitoring
Mattioli 1885 イタリア Overview A recent report on the 2026 glucose monitoring market highlights the transformative role of Continuous Glucose Monitoring (CGM) in diabetes management. It underscores that robust quality indicators—specifi... -
FDA Warns: Smartwatches Lack Medical-Grade Accuracy for Non-Invasive Blood Glucose Monitoring in 2026
[Unnamed Health Publication] USA Overview As of 2026, peer-reviewed research on non-invasive blood glucose monitoring via consumer wearables remains limited. The FDA and Johns Hopkins University explicitly state no wrist-worn device exis... -
Non-Invasive Blood Sugar Monitoring Faces Accuracy and Reliability Hurdles; True Non-Invasive Devices Remain Undeveloped
Health.com USA Overview While non-invasive blood sugar meters hold promise for finger-prick-free glucose checks, most currently available devices fail to meet the expected medical-grade accuracy and reliability for daily tracking. Many p... -
Diabetes Devices Dominate FDA MAUDE Reports 2020-2025 with Over 50% of Adverse Events, Dexcom Largest Single Reporter
Global MedTech Expert | 10× MedTech Global Access Unknown Overview An analysis of 14.4 million FDA MAUDE adverse event reports from 2020 to 2025 reveals that diabetes-related devices account for over half of all reported events. Continuo... -
Zoll Corporation Receives FDA Warning Letter Over Quality Concerns Regarding AccuVent Sensor Malfunction Handling
MedTech Dive USA Overview Zoll Corporation has received a Warning Letter from the U.S. FDA regarding quality concerns, specifically citing inadequate handling of complaints related to malfunctions of its AccuVent sensors used in ventilat... -
FDA Clears Dexcom’s Stelo, First Over-the-Counter CGM for Non-Insulin-Using Children Aged Two and Older
FDA USA Overview The U.S. FDA has approved Dexcom's Stelo Glucose Biosensor System as the first over-the-counter (OTC) continuous glucose monitor (CGM) for children aged two and older who do not use insulin. This expansion significantly ...
