BrioHealth announced that it received conditional FDA approval to conduct a clinical evaluation of its ventricular assist device (VAD) in pediatric patients.
SEOUL, South Korea, April 24, 2026 /PRNewswire/ — CGBIO (CEO: Hyunseung Yu) announced that its patient-specific titanium implant, EASYMADE TI, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on April 9. The FDA 510(k) pathway is a premarket clearance process that demonstrates substantial equivalence to a legally marketed predicate device, allowing commercialization in the United States.
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its ApexCut surgical blades for ENT procedures.
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
Biotronik announced today that it received FDA approval for its Acticor Sky and Rivacor implantable defibrillator systems.
The newly approved HIV drug Idvynso will also help Merck diversify as loss of exclusivity looms over its top-selling product, the mega-blockbuster cancer drug Keytruda.
In the U.S., Moderna withdrew its approval application for the combination vaccine in May last year and the timeline for resubmission remains uncertain.
The ArteraAI prostate biopsy assay predicts the risk of prostate cancer progression.
Approval for Xeltis’s aXess device was based on pivotal trial data that demonstrated 79% secondary patency and a patency related reintervention rate of 1.3 per patient year.
Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its Rembra platform of scanning systems.