Radiology

Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Breast Cancer

QUEENSBURY, N.Y.–(BUSINESS WIRE)–Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company’s Investigational New Drug (IND) application for a Phase 2 clinical trial […]

HistoSonics’ Histotripsy System Demonstrates 90% Local Tumor Control at 12 Months in #HOPE4LIVER Trials

MINNEAPOLIS–(BUSINESS WIRE)–HistoSonics, the developer of the Edison Histotripsy System, announced today 12-month follow-up clinical data from its prospective #HOPE4LIVER trials, designed to evaluate the safety and efficacy of histotripsy for the non-invasive destruction of primary (hepatocellular cancer-HCC) and metastatic liver tumors. “The one-year outcome data for the HOPE4LIVER trial are […]

Agitated Solutions Receives IND Clearance from FDA to Initiate Phase 3 Clinical Trial of a Novel Contrast Agent

Multi-center trial will assess safety and efficacy of ASI-02 contrast agent in cardiac bubble studies. ST. PAUL, Minn.–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) has cleared Agitated Solutions, Incorporated (ASI)’s Investigational New Drug (IND) application for its novel contrast agent, ASI-02, enabling the initiation of the company’s Phase 3 clinical trial. […]

Breakthrough AI Indicator for HFpEF and Cardiotoxicity Added to Exo Iris®

Exo unveils its 10th FDA-cleared AI, delivering instant, on-device Global Longitudinal Strain (GLS) analysis — no cloud, no lag, no guesswork Identify signs of heart failure and cardiotoxicity SANTA CLARA, Calif.–(BUSINESS WIRE)–Exo (pronounced “echo”), the leader in AI-powered, accessible medical imaging, announced its latest FDA 510(k) clearance for Global Longitudinal Strain […]

Seven New Data Sets Demonstrate Penumbra’s Computer Assisted Vacuum Thrombectomy (CAVT) Technology Is Safe, Fast and Effective, Improves Patient Outcomes, and Delivers Healthcare Resource Benefits

ALAMEDA, Calif., April 2, 2025 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN), the world’s leading thrombectomy company, announced seven significant computer assisted vacuum thrombectomy (CAVT™) data presentations during the 2025 Society of Interventional Radiology (SIR) Annual Scientific…