Category: CERTIFICATIONS

Neurophet Secures FDA 510(k) Clearance for “Neurophet AQUA AD Plus,” Marking Its Third U.S. Regulatory Milestone

February 6, 2026

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

February 6, 2026

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

February 6, 2026

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

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.

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

February 5, 2026

With this FDA approval, Hologic now offers three guideline-recommended methods: Pap testing, HPV primary testing, and co-testing.

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

February 5, 2026

The implantable blood pressure sensor will now be available to patients with chronic heart failure through the NHS.

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

February 5, 2026

Zimmer Biomet (NYSE: ZBH)+
announced today that it received FDA 510(k) clearance for its G7 acetabular system for hip replacement surgeries.

Acarix Receives EU MDR Certification for the CADScor®System

February 4, 2026

OKLAHOMA CITY, Feb. 4, 2026 /PRNewswire/ — Acarix today announced its CADScor®System has successfully achieved certification under the European Union Medical Device Regulation (EU MDR 2017/745).

TSC Life wins FDA clearance for pediatric use of Fluido system

February 4, 2026

TSC Life announced that it received FDA clearance for its Fluido Compact fluid warming system for pediatric use.

Blog

- CERTIFICATIONS

Neurophet Secures FDA 510(k) Clearance for “Neurophet AQUA AD Plus,” Marking Its Third U.S. Regulatory Milestone

FDA grants clearance for Eyas Medical Imaging’s neonatal MRI system

Sonorous Neurovascular earns FDA breakthrough mark for novel stent

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

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

Acarix Receives EU MDR Certification for the CADScor®System

TSC Life wins FDA clearance for pediatric use of Fluido system