Nutromics Receives FDA Breakthrough Device Designation
Melbourne, Australia, September 10, 2026 Nutromics has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough...
Medical Devices
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AEYE-DS Data Show 99% Imageability in Eye Screening
Tel Aviv, Israel, September 9, 2026 AEYE announced publication of clinical-trial findings evaluating AEYE-DS, an autonomous artificial intelligence-based screening...
Emboline Receives FDA 510(k) Clearance for Emboliner
San Jose, California, September 9, 2026 Emboline has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its...
UCB Wins FDA Breakthrough Therapy Designation for CIMZIA
Brussels, Belgium, September 9, 2026 UCB announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy...
CraniUS Wins FDA 510(k) Clearance for Cranial Implant
Baltimore, Maryland, September 9, 2026 CraniUS Therapeutics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the...
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Anitoa Adds Secure Cloud Connectivity to Portable qPCR
Sunnyvale, California, U.S., September 8, 2026 Anitoa Systems, LLC has announced the integration of secure cloud connectivity and enterprise-grade...
FDA Seeks Input to Advance Botanical Drug Development
Silver Spring, Maryland, USA, September 3, 2026 The U.S. Food and Drug Administration (FDA) has issued a Request for...
AbbVie Completes $10.9 Billion Apogee Acquisition
North Chicago, Illinois, USA, September 3, 2026 AbbVie has completed its acquisition of Apogee Therapeutics, strengthening the pharmaceutical company’s...
Acepodia Gains FDA IND Clearance for ACE723 ADC
Alameda, California, USA, September 4, 2026 Acepodia has announced that the U.S. Food and Drug Administration (FDA) has cleared...
Globus Medical Gains CE Mark for Excelsius3D Imaging
Audubon, Pennsylvania, USA, September 3, 2026 Globus Medical has announced that its Excelsius3D™ Imaging System has received the CE...
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