MedTech News
BRAIN.Q Achieves CE Mark for Its Breakthrough Therapy for Reducing Disability Following Stroke and Welcomes Stacey Pugh as Chairman of the Board
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.
Q’Apel Medical Announces CE Mark Approval for Armadillo SelectFlex™ Neurovascular Access System
FREMONT, Calif., Jan. 13, 2025 /PRNewswire/ — Q’Apel Medical (Q’Apel), a privately held medical device company focused on revolutionizing neurovascular interventions, today announced it has received CE mark certification for its Armadillo SelectFlex™ Neurovascular Access System. The first-of-its-kind 7F system features the patented SelectFlex™ Technology and is indicated for the introduction of interventional devices into the neurovasculature.
ZEISS MEL 90 excimer laser receives U.S. FDA approval; completes Corneal Refractive Workflow
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).
Spear Bio Secures FDA Breakthrough Device Designation for its Novel pTau 217 Blood Test, Advancing Scalable Solutions for Early Alzheimer’s Disease Diagnosis
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.
Medtronic wins CE mark for adaptive deep brain stim tech for Parkinson’s
Medtronic (NYSE: MDT)+
announced today that it received CE mark approval for its BrainSense adaptive deep brian stimulation (aDBS).
Scientists engineer nanostructured surfaces hostile to bacteria but friendly to cells
Researchers from Tokyo Metropolitan University have created nanostructured alumina surfaces which are strongly antibacterial but can be used to culture cells.
FDA clears CapsoVision capsule endoscopy tech for pediatric patients
CapsoVision announced today that the FDA cleared its CapsoCam Plus system for use in pediatric patients aged two and above.
Johnson & Johnson MedTech wins CE mark for dual-energy catheter
Johnson & Johnson MedTech (NYSE: JNJ)+
announced today that it received CE mark approval for its dual-energy ThermoCool SmartTouch SF catheter to treat AFib