FDA clears InterVene’s in-stent restenosis catheter
November 3, 2025
InterVene’s Recana is claimed to be the first fully integrated catheter system to address venous in-stent restenosis (ISR).
InterVene’s Recana is claimed to be the first fully integrated catheter system to address venous in-stent restenosis (ISR).
Pulsenmore announced today that it received FDA de novo clearance for its home-use prenatal ultrasound platform.
Wandercraft announced today that the FDA expanded the indications for its flagship Atalante X rehabilitation device.
The clearance from the US regulator broadens the company’s diagnostic imaging offerings.
InterVene announced today that it received FDA 510(k) clearance for its Recana thrombectomy catheter system.
Studies showed that the assay demonstrated a 94.90% sensitivity in polymerase chain reaction-confirmed positive samples.
GROVE CITY, Ohio, Oct. 30, 2025 /PRNewswire/ — Tosoh Bioscience, Inc., a market leader in clinical diagnostics has received U.S. FDA 510(k) clearance for its next-generation Tosoh Automated Glycohemoglobin Analyzer HLC®-723 GR01 (GR01) for HbA1c testing.
National Medicare coverage paves the way for a larger patient population to access the blood pressure treatment, which gained FDA approval in 2023.
REDMOND, Wash., Oct. 28, 2025 /PRNewswire/ — Perimetrics, Inc., a dental technology company pioneering quantitative diagnostics, announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for the InnerView® System — the first FDA-cleared technology designed to measure both internal and external mobility in teeth and implants.
Zimmer Biomet (NYSE: ZBH)+
announced today that it received FDA breakthrough device designation for its iodine-treated total hip replacement system.