C2N Diagnostics’ FDA-cleared PrecivityAD2 combines amyloid and tau measurements in a mass-spectrometry test intended to aid assessment of symptomatic adults aged 40 and older.
Empatica can now bring PKG-derived Parkinson’s measures into its wearable ecosystem after FDA clearance of a platform designed for continuous symptom monitoring.
ZEISS CLINIC 360 can consolidate ophthalmic images, diagnostic information and glaucoma progression analysis in a browser-based Class II medical device.
FDA Premarket Approval gives Implantica a US launch pathway for RefluxStop after long-term clinical evidence tested an implant that avoids encircling the esophagus.
New Day Skin Spray uses a silk fibroin-containing barrier formulation and reached the US market through FDA’s 510(k) medical-device pathway rather than drug approval.
FDA Fast Track designation could increase regulatory interaction around safusidenib while Nuvation Bio tests the IDH1 inhibitor across several glioma settings.
FDA authorizes Vitestro’s Aletta robotic blood draw device via De Novo. See how its clinical data could reshape outpatient phlebotomy.