Labcorp’s advanced melanoma CDx secures FDA approval
August 10, 2026
Labcorp’s CDx is designed to detect BRAF V600E and V600K melanoma mutations to determine which patients are eligible for BRAF inhibitor regimens.
Labcorp’s CDx is designed to detect BRAF V600E and V600K melanoma mutations to determine which patients are eligible for BRAF inhibitor regimens.
Older ablation approaches for ventricular tachycardia have been suboptimal, Medtronic said. The company plans to bring a more effective treatment for the life-threatening heart condition.
The system pairs a 122‑electrode spherical array with real‑time thermal contact sensing and visualisation to guide ablation and confirm treatment.
BlueWind plans to initiate a limited US market launch of Revi Extend in Q4 2026.
SINGAPORE, Aug. 6, 2026 /PRNewswire/ — Genesis MedTech has received CE Mark approval for its latest 8 mm video endoscope, marking an important milestone in minimally invasive imaging. Achieving 3D imaging, 4K resolution and fluorescence capability in an 8 mm endoscope has been one of the key engineering challenges in advanced surgical visualisation.
Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Omni Ultra Surgical System (Omni Ultra) for canaloplasty followed by trabeculotomy for the reduction of intraocular pressure (IOP) in adult patients with primary open-angle glaucoma (POAG).
BlueWind Medical announced today that it received FDA 510(k) clearance for Revi Extend, its next-generation implant.
BURLINGTON, N.C., Aug. 4, 2026 /PRNewswire/ — Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced the nationwide availability of Roche’s VENTANA® PTEN (SP218) RxDx Assay, the first immunohistochemistry (IHC) companion diagnostic test approved by the U.S. Food and Drug Administration (FDA) to determine PTEN protein loss, also known as PTEN deficiency, in tumors of patients with prostate adenocarcinoma. The assay helps identify patients who may be eligible for treatment with AstraZeneca’s TRUQAP® (capivasertib) in combination with abiraterone acetate and prednisone.
Certification strengthens Koning’s global regulatory foundation as two new Vera Breast CT systems expand patient access in key U.S. markets
Cortechs.ai, a San Diego, CA-based provider of AI-powered quantitative imaging solutions, has announced the expansion of its European CE Marking under the European Union Medical Device Regulation (EU MDR) for its latest imaging products.