Category: CERTIFICATIONS - Page 2 - Start Medical Product Development

Labcorp to Offer First FDA-Cleared Blood Test to Detect Alzheimer’s Disease Pathology in Both Primary and Specialty Care Settings

August 24, 2026

BURLINGTON, N.C., Aug. 24, 2026 /PRNewswire/ — Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today it will offer the Elecsys® pTau-217 test following clearance by the U.S. Food and Drug Administration (FDA). Developed by Roche Diagnostics, the blood test aids in identifying amyloid pathology associated with Alzheimer’s disease in individuals 55 and older with signs, symptoms or complaints of cognitive decline. Elecsys® pTau-217 is the first and only FDA-cleared single-biomarker blood test to both rule in and rule out amyloid pathology across specialty and primary care settings

Roche’s pTau217 single-biomarker Alzheimer’s blood test lands FDA approval

August 24, 2026

FDA clearance for Roche’s pTau217 follows the blood-based test’s receipt of a European CE mark in May 2026.

FDA clears C2N Diagnostics’ early Alzheimer’s assessment test

August 21, 2026

C2N’s Alzheimer’s test is the first to be FDA-cleared for use in patients as young as 40 who present with cognitive impairment symptoms.

FDA authorizes first-of-its-kind autonomous robotic blood draw device

August 21, 2026

The FDA granted de novo classification to a standalone robotic device that can draw blood from a patient’s arm without a hands-on operator.

Implantica receives FDA approval for RefluxStop® – Opening the U.S. market

August 20, 2026

VADUZ, Liechtenstein, Aug. 21, 2026 /PRNewswire/ — Implantica AG (publ.), a medtech company at the forefront of introducing advanced technology into the body, announced today that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for RefluxStop®, the company’s implant-based treatment for gastroesophageal reflux disease (GERD). The approval allows Implantica to begin commercial launch activities in the United States, the world’s largest medical device market.

Maverix Medical Announces FDA 510(k) Clearance for the Narwhal™ Cryo System

August 20, 2026

Console-free, single-use cryoprobe brings cryobiopsy to the bronchoscopy suite without dedicated capital equipment

Hematogenix’s MM MRD Assay Underpins FDA Accelerated Approval of Bristol Myers Squibb’s ZENBEXUS™, the First Approved CELMoD Therapy for Multiple Myeloma

August 19, 2026

Hematogenix’s proprietary Multiple Myeloma MRD (MM MRD) assay measured the primary efficacy endpoint cited in the FDA-approval of ZENBEXUS (iberdomide), reinforcing Hematogenix’s role as a specialized global leader in registrational oncology trials.

Cortechs.ai Announces FDA Clearance for NeuroQuant® PET: Advancing Molecular Imaging for Cognitive Impairment

August 19, 2026

COVINGTON, Ky., Aug. 18, 2026 /PRNewswire/ — NeuroQuant ® PET has received FDA 510(k) clearance (K261916) for PET. NeuroQuant PET ® aids physicians in the evaluation of patient pathologies and the clinical interpretation of PET performed for the assessment of cognitive impairment and other neurological conditions.

Livi®, the First FDA-Cleared After-Sex Absorption Device, Is Now Available

August 19, 2026

Doctor-created Livi addresses a long-overlooked need in post-sex intimate health, available exclusively at MyLivi.com.

ZEISS CLINIC 360 receives FDA 510k clearance, amplifying patient care through simplified clinical insights

August 19, 2026

The ZEISS CLINIC 360 all-in-one browser-based software solution aggregates clinical data at scale and powers advanced analytics for streamlined ophthalmic workflows, providing clinicians with more time for personalizing patient care.

Blog

- CERTIFICATIONS

Labcorp to Offer First FDA-Cleared Blood Test to Detect Alzheimer’s Disease Pathology in Both Primary and Specialty Care Settings

Roche’s pTau217 single-biomarker Alzheimer’s blood test lands FDA approval

FDA clears C2N Diagnostics’ early Alzheimer’s assessment test

FDA authorizes first-of-its-kind autonomous robotic blood draw device

Implantica receives FDA approval for RefluxStop® – Opening the U.S. market

Maverix Medical Announces FDA 510(k) Clearance for the Narwhal™ Cryo System

Hematogenix’s MM MRD Assay Underpins FDA Accelerated Approval of Bristol Myers Squibb’s ZENBEXUS™, the First Approved CELMoD Therapy for Multiple Myeloma

Cortechs.ai Announces FDA Clearance for NeuroQuant® PET: Advancing Molecular Imaging for Cognitive Impairment

Livi®, the First FDA-Cleared After-Sex Absorption Device, Is Now Available

ZEISS CLINIC 360 receives FDA 510k clearance, amplifying patient care through simplified clinical insights