JD Supra2d
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
FDA clears migraine device for children as young as 8
A device long used by adults to manage migraines was now available for children as young as eight years old, offering new ...
Targeted Oncology3d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Healio5d
FDA clears first assay designed to measure lipoprotein(a) in nanomoles
Roche announced its next generation assay received FDA 510(k) clearance for the measurement of lipoprotein(a) for assessment ...
Targeted Oncology2d
FDA Grants 225Ac-SSO110 Orphan Drug Status in SCLC
Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...
Interesting Engineering on MSN4d
Breakthrough: US FDA clears first gene-edited pig kidney transplants in humans
In a significant development for organ transplantation, two U.S. biotechnology companies, United Therapeutics and ...
Interesting Engineering on MSN4d
US FDA approves first-ever smart glasses with hearing aid for mild to moderate loss
EssilorLuxottica's Nuance Audio Glasses receive FDA clearance for OTC sales in the US, revolutionizing hearing solutions with ...
GlobalData on MSN6d
EssilorLuxottica wins FDA clearance and EU approval for OTC audio glasses
EssilorLuxottica has received approval in the US and EU to market its Nuance audio glasses, a device that combines hearing ...
EssilorLuxottica receives FDA clearance for its Nuance audio glasses
EssilorLuxottica said on Monday it received a green light from the U.S. Food and Drug Administration (FDA) for its ...
MassDevice4d
FDA clears AI 3D head, neck imaging tech from RapidAI
RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution.
HCW Biologics Granted FDA Clearance to Evaluate One of the Company’s Lead Product Candidates in a First-In-Human Phase 1 Clinical Trial
Wong, Founder and CEO of HCW Biologics, commented, “The FDA’s clearance to initiate our first-in-human clinical trial for HCW9302 brings us one step closer to advancing a potentially transformative ...
Healio4d
FDA grants 510(k) clearance to AI Optics’ handheld retinal imaging system
The FDA has granted 510(k) clearance to AI Optics’ Sentinel Camera, a handheld retinal imaging system that captures ...