Carl Zeiss Meditec wins FDA clearance for CLINIC 360 ahead of US ophthalmology launch
ZEISS CLINIC 360 can consolidate ophthalmic images, diagnostic information and glaucoma progression analysis in a browser-based Class II medical device.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
Implantica wins FDA PMA for RefluxStop as five-year GERD data move into a US commercial test
FDA Premarket Approval gives Implantica a US launch pathway for RefluxStop after long-term clinical evidence tested an implant that avoids encircling the esophagus.
Medical Devices & Diagnostics
Evolved By Nature’s peptide technology reaches atopic dermatitis patients through an unusual 510(k) route
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.
Pharma & Biotech
Nuvation Bio’s safusidenib gets FDA Fast Track, but Phase 3 SIGMA remains the decisive test
FDA Fast Track designation could increase regulatory interaction around safusidenib while Nuvation Bio tests the IDH1 inhibitor across several glioma settings.
Medical Devices & Diagnostics
Vitestro’s Aletta wins FDA De Novo authorization as robotic phlebotomy moves toward US clinics
FDA authorizes Vitestro’s Aletta robotic blood draw device via De Novo. See how its clinical data could reshape outpatient phlebotomy.