Category: CERTIFICATIONS - Page 27 - Start Medical Product Development

Vesalio Expands International Neurovascular Portfolio with CE Mark of NeVa VS and NeVa 3.0 mm and Receives Additional FDA 510(k) Clearance for its Aspiration Catheters

February 10, 2026

PLANO, Texas, Feb. 10, 2026 /PRNewswire/ — Vesalio, a global leader in vascular intervention, today announced CE Mark certification and the European commercial launch of two new neurovascular devices: NeVa™ VS, for the treatment of cerebral vasospasm following aneurysmal subarachnoid hemorrhage (aSAH), and the NeVa™ 3.0 mm Thrombectomy System for stroke. In addition, the Company received an additional U.S. Food and Drug Administration (FDA) 510(k) clearance expanding the indications of its neurovascular and peripheral aspiration catheters to include distal access.

TransMedics Receives Full and Unconditional FDA IDE Approval for Next-Generation OCS Heart ENHANCE Trial

February 9, 2026

ANDOVER, Mass., Feb. 9, 2026 /PRNewswire/ — TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of its Investigational Device Exemption (IDE) for the Next-Generation OCS ENHANCE Heart trial.

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.

Blog

- CERTIFICATIONS

Vesalio Expands International Neurovascular Portfolio with CE Mark of NeVa VS and NeVa 3.0 mm and Receives Additional FDA 510(k) Clearance for its Aspiration Catheters

TransMedics Receives Full and Unconditional FDA IDE Approval for Next-Generation OCS Heart ENHANCE Trial

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