Day: February 5, 2026

P&F Secures EU MDR CE Certification for TricValve® System

February 5, 2026

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

February 5, 2026

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

February 5, 2026

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.

Blog

- February 5, 2026

P&F Secures EU MDR CE Certification for TricValve® System

First-of-its-kind Universal Clearance Establishes Maximum Regulatory Access to the Bezier Parametric Curve Spinal Rod System for Patients and Surgeons

LEADOPTIK Announces First-in-Human Use of FDA-Cleared LIA™ System

Insulet launches Omnipod 5, Omnipod Discover in the Middle East

New vaccine platform promotes rare protective B cells

Hologic’s Aptima assay secures FDA approval for HPV primary screening

UK’s NICE greenlights Abbott’s CardioMEMS heart failure sensor

Zimmer Biomet gets FDA nod for newest addition to G7 hip implant line