FREE DESIGN AUDIT
Free Design Audit Available - Click Here for Details

Blog

- CERTIFICATIONS

Medtronic receives FDA clearance for Stealth AXiS™ surgical system, first integrated planning, navigation and robotics platform for spine surgery

February 13, 2026

GALWAY, Ireland, Feb. 13, 2026 /PRNewswire/ — Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS™ surgical system, a next-generation platform that brings planning, navigation, and robotics together into a single, intelligent system for spine surgery.

Read More »

Labcorp Launches First FDA-Cleared Blood Test for Alzheimer’s Disease Assessment in Primary Care

February 11, 2026

BURLINGTON, N.C., Feb. 11, 2026 /PRNewswire/ — Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the nationwide availability of the Elecsys® pTau-181 test, the first and only blood test cleared by the U.S. Food and Drug Administration (FDA) to aid in the initial assessment of Alzheimer’s disease in the primary care setting. This launch further expands Labcorp’s comprehensive portfolio of Alzheimer’s disease blood tests, offering clinicians solutions across both primary and specialty care settings.

Read More »

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.

Read More »

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.

Read More »

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).

Read More »