CergenX wins FDA breakthrough nod for neonatal brain monitoring tech
January 20, 2025
CergenX announced today that the FDA granted breakthrough device designation for its Wave device for neonatal brain monitoring.
CergenX announced today that the FDA granted breakthrough device designation for its Wave device for neonatal brain monitoring.
ENGLEWOOD CLIFFS, N.J., Jan. 13, 2025 /PRNewswire/ — BRAIN.Q, is excited to announce the CE Mark for its BQ 2.0 system, designed to reduce disability following ischemic stroke, the number one cause of disability worldwide.
DUBLIN, Calif. and JENA, Germany, Jan. 13, 2025 /PRNewswire/ — ZEISS Medical Technology announced today that the MEL® 90 received approval from the U.S. Food and Drug Administration (FDA), giving the excimer laser technology simultaneous approval for all three major indications, including myopia, hyperopia and mixed astigmatism (a condition where both hyperopic and myopic correction is required).
WOBURN, Mass., Jan. 13, 2025 /PRNewswire/ — Spear Bio Inc., a biotechnology company pioneering next-generation ultra-sensitive immunoassays, today announced that its pTau 217 blood test has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This recognizes the test’s potential to address a critical unmet need for the millions of Americans living with Alzheimer’s disease and not yet diagnosed.
CapsoVision announced today that the FDA cleared its CapsoCam Plus system for use in pediatric patients aged two and above.
TUCSON, Ariz., Jan. 9, 2025 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its whole slide imaging system, Roche Digital Pathology Dx, has received an additional 510(k) clearance from the United States Food and Drug Administration (FDA).
Alleviant Medical announced today that it received FDA investigational device exemption (IDE) and breakthrough device designation for its atrial shunt.
AccurKardia announced today that it received FDA breakthrough device designation for its ECG-based, AI-powered hyperkalemia detection software.
Medtronic (NYSE: MDT)+
today announced CE mark approval for its Harmony transcatheter pulmonary valve (TPV) system
Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA premarket approval for its Wrapsody cell-impermeable endoprosthesis.