Medical Device Network on MSN

Medtronic’s OmniaSecure defib lead nets another FDA approval

OmniaSecure is now the first defibrillation lead approved for placement in the left bundle branch.
Fierce Biotech

JenaValve's Trilogy valve secures FDA's 1st approval in aortic regurgitation

JenaValve has secured the FDA’s approval for its minimally invasive heart implant, making it the first to claim a U.S. green ...
Medical Device Network on MSN

LivaNova eyes 2027 launch of neural sleep apnoea therapy after FDA approval

LivaNova's aura6000 system delivers synchronised electrical pulses to the hypoglossal nerve to prevent airways collapse in OSA patients during sleep.
Healthline

Which Products Does the FDA Regulate?

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...
Medical Device Network on MSN

FDA approves J&J’s TECNIS PureSee intraocular lens

The TECNIS PureSee IOL addresses both cataract-related vision loss and presbyopia, which affects near vision as eyes age.
The American Journal of Managed Care

5 FDA Developments From February: Kinase Inhibitors, GLP-1s, and a New Approval Pathway

Zongertinib gained accelerated approval for unresectable/metastatic HER2 kinase-domain–mutant nonsquamous NSCLC, with 76% ORR and DOR ≥12 months in 44%. AMPLIFY ...