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.
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.
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.
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.
Console-free, single-use cryoprobe brings cryobiopsy to the bronchoscopy suite without dedicated capital equipment
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.
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.
Doctor-created Livi addresses a long-overlooked need in post-sex intimate health, available exclusively at MyLivi.com.
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.
Empatica’s platform enables continuous tracking of symptoms such as bradykinesia, dyskinesia and sleep quality.
The approval covers smartSedLine monitor availability in applicable European markets.