Browsing Tag
CE Mark
7 posts
Roche secures FDA clearance and CE Mark for rapid pertussis point-of-care diagnostic test
Discover how Roche’s FDA-cleared rapid pertussis test could transform point-of-care diagnosis and reshape decentralized molecular diagnostics worldwide.
December 2, 2025
Europe says yes to AI embryo selection—Can Alife Health’s CE-certified tool transform fertility labs?
Find out how Alife Health’s CE-marked AI embryo selection tool is set to transform IVF labs across Europe and drive clinical outcomes in fertility care.
October 26, 2025
Cardiovalve completes TARGET study enrollment as Venus Medtech prepares CE mark filing for tricuspid valve system
Cardiovalve completes CE registration trial for tricuspid valve system as Venus Medtech eyes 2027 European launch. Learn what’s next in structural heart therapy.
October 26, 2025
Avita Medical (ASX: AVH) stock surges 25% after Europe clears Recell GO – but can momentum last?
Avita Medical (ASX: AVH, NASDAQ: RCEL) stock soared 25% after CE Mark approval for RECELL GO in Europe. Explore how this milestone reshapes investor outlook.
September 16, 2025
ZEISS gains CE mark for CIRRUS PathFinder AI tool to enhance ophthalmic scan decision support
ZEISS earns CE mark for CIRRUS PathFinder, its integrated AI tool for OCT scan decision support. Find out how it could change ophthalmic diagnostics.
August 23, 2025
Bioretec expands globally with CE mark approval for absorbable RemeOs trauma screws
Bioretec Ltd., a leader in absorbable implant technology, has reached a critical regulatory milestone with the successful CE…
February 15, 2025
FDA greenlights Medtronic’s dual-energy ablation—could this be the future of AFib treatment?
Medtronic has achieved a major milestone with the U.S. Food and Drug Administration (FDA) granting approval for its…
October 25, 2024