
SkylineDX’s predictive melanoma test secures FDA breakthrough designation
SkylineDX’s test stratifies cutaneous melanoma patients into metastatic risk categories to inform treatment decisions.

SkylineDX’s test stratifies cutaneous melanoma patients into metastatic risk categories to inform treatment decisions.

BLOOMINGTON, Minn., June 30, 2026 /PRNewswire/ — Saluda Medical, Inc. (ASX: SLD, “Saluda” or the “Company”), a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed-loop neuromodulation platform, today announced that the U.S. Food and Drug Administration (“FDA”) has approved Saluda’s CAP24 paddle lead, allowing it to be marketed and sold in the U.S.

Sensitive test looking for key genetic mutation detects high-risk patients missed by standard testing

Aurenar announced today that it received FDA breakthrough device designation for its V-Link noninvasive neuromodulation system.

Novocure (Nasdaq:NVCR) announced today that its Optune Pax device for treating pancreatic cancer received CE mark approval.

StarMed announced today that it received FDA 510(k) clearance for its platform that delivers radiofrequency (RF) ablation of thyroid nodules.

MINNEAPOLIS, June 29, 2026 /PRNewswire/ — Laplace Interventional today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) for TRIUMPH, the company’s pivotal trial evaluating its Transcatheter Tricuspid Valve Replacement (TTVR) system.

IntelliGenome, Inc., a molecular diagnostics company advancing next-generation tuberculosis detection technologies, today announced that Colombia’s National Institute for Food and Drug Surveillance (INVIMA) has granted sanitary registration for the CRISPR-TB Blood Test Kit.

Edwards Lifesciences (NYSE:EW) has earned FDA 510(k) clearance for Ecliptis, its left atrial appendage (LAA) exclusion system.

Artivion (NYSE:AORT) announced today that it received FDA premarket approval (PMA) for its AMDS Hybrid Prosthesis device.