Vein360 has announced it received US Food and Drug Administration (FDA) 510(k) clearance for reprocessing the Philips Visions PV 0.035 digital intravascular ultrasound (IVUS) catheter in June of 2023 and the Visions PV 0.018 digital IVUS catheter in August of 2023. In addition, the company received FDA 510(k) clearance to reprocess the Visions PV.014P RX digital IVUS catheter, reprocessed Eagle Eye Platinum RX digital IVUS catheter, reprocessed Eagle Eye Platinum ST RX digital IVUS catheter, and reprocessed Visions PV.014P RX digital IVUS catheter in October 2023.
Vein360’s co-founder and chief medical officer Chris Meyer commented in the company’s press release: “As independent endovascular physicians, our reimbursement for IVUS has eroded so much that we are often paid less than the cost of the catheter. This hurts our ability to work autonomously in our own OBLs [office-based labs] and ASCs [ambulatory surgery centres]. It was clear to us that the Philips IVUS with its phased array transducers was easier to use and had superior image quality when compared to Boston’s Opticross. Our goal in the submissions was to get this superior technology in the hands of physicians while allowing them to maintain profitability when performing IVUS. At Vein360, we will continue to work tirelessly to reduce procedural cost so that physicians can focus on patient care.”
Vein360’s CEO Suzanne Meyer commented: “This achievement is a testament to the dedication, hard work, and unwavering commitment of the Vein360 team. We believe in the power of innovation to make healthcare more sustainable and accessible, and this US FDA clearance reaffirms our commitment to that vision. Vein360 has obtained three US FDA 510(k) clearances in the past five months. Our customers can expect more exciting news that will add significant value to their practices in the near future.”