MedTech News
.................... by Andrew Celentano
Neurophet Secures FDA 510(k) Clearance for “Neurophet AQUA AD Plus,” Marking Its Third U.S. Regulatory Milestone
SEOUL, South Korea, Feb. 6, 2026 /PRNewswire/ — Neurophet (Co-CEOs Jake Junkil Been and Donghyeon Kim), an artificial intelligence (AI) solution company for brain disorders diagnosis and treatment, announced today that its software solution, Neurophet AQUA AD Plus, a comprehensive neuroimaging analysis solution for clinical evaluation related to Alzheimer’s disease, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
FDA grants clearance for Eyas Medical Imaging’s neonatal MRI system
Eyas Medical Imaging is currently scaling up operations with plans to commercialise the system in the US later this year.
Sonorous Neurovascular earns FDA breakthrough mark for novel stent
Sonorous Neurovascular received FDA breakthrough device designation for its BosSTENT device intended to treat pulsatile tinnitus, the company announced on Thursday.
P&F Secures EU MDR CE Certification for TricValve® System
VIENNA, Feb. 5, 2026 /PRNewswire/ — P&F Products and Features GmbH, a global heart valve MedTech company focused on transcatheter solutions for structural heart disease, today announced it has received CE Mark certification under the European Union Medical Device Regulation (MDR) 2017/745 for its TricValve® Transcatheter Bicaval Valve System. The certification confirms TricValve’s compliance with the EU’s most stringent medical device regulatory requirements.
First-of-its-kind Universal Clearance Establishes Maximum Regulatory Access to the Bezier Parametric Curve Spinal Rod System for Patients and Surgeons
FORT LAUDERDALE, Fla., Feb. 5, 2026 /PRNewswire/ — The Bezier Parametric Curve Rod System from Spinal Resources, Inc. has received 510(k) clearance for compatibility with any cleared pedicle screw set available on the US market, regardless of manufacturer.
LEADOPTIK Announces First-in-Human Use of FDA-Cleared LIA™ System
SAN JOSE, Calif., Feb. 5, 2026 /PRNewswire/ — LEADOPTIK, Inc., a medical technology company focused on advancing precision lung cancer biopsy, today announced the successful first-in-human clinical use of its FDA-cleared Last Inch Assessment™ (LIA) System at University of Chicago Medical Center.
Insulet launches Omnipod 5, Omnipod Discover in the Middle East
Insulet (Nasdaq:PODD) announced today that it launched its Omnipod 5 and Omnipod Discover offerings in the Middle East.
New vaccine platform promotes rare protective B cells
Based on a virus-like particle built with a DNA scaffold, the approach could generate broadly neutralizing antibody responses against HIV or influenza.