Roche announced its next generation assay received FDA 510(k) clearance for the measurement of lipoprotein(a) for assessment ...

EssilorLuxottica said on Monday it received a green light from the U.S. Food and Drug Administration (FDA) for its ...

Emily Hernandez, a Missouri woman pardoned after her ties to the Jan. 6, 2021, insurrection at the U.S. Capitol, was ...

RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution.

Two US biotech companies say the Food and Drug Administration has cleared them to conduct clinical trials of their gene-edited pig kidneys for human transplants.

EssilorLuxottica has received approval in the US and EU to market its Nuance audio glasses, a device that combines hearing ...

The Phase 1b/2a study will assess the safety of CNP-103 in adults (aged 18-35) and pediatrics (aged 12-17) who have Stage III or newly diagnosed (within the last 6 months) T1D as well as C-peptide ...

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 ...

I got to try out EssilorLuxottica’s Nuance Audio glasses last month at CES 2025. They look like normal glasses, but can amplify the voice of whoever you’re speaking to while also dampening noisy ...

The approval adds a new indication for GLP-1 drugs and gives Novo an advantage over Lilly’s rival diabetes drug Mounjaro, ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Imperative Care’s Zoom System, marking an ...