Medical imaging biotech LUMA Vision has received FDA 510(k) clearance for its Verafeye heart imaging platform.
The ultrasound-based cardiac visualization and navigation platform delivers a 360-degree view. This enables real-time imaging and navigation of all surrounding structures and devices near the catheter with “an unmatched field of view,” says LUMA Vision.
Verafeye features both 2D and 4D imaging with 360-degree visualization. This allows for dynamic, high-resolution images of the heart’s internal structures.
Combined with LUMA Vision’s proprietary catheter sensor, the platform delivers enhanced precision and real-time guidance during catheter-based cardiac procedures to improve clinical decision-making and reduce risks.
Conventional imaging catheters are limited to 2D views. This restricts clinicians’ ability to fully visualize cardiac anatomy during procedures.
Verafeye’s real-time 4D imaging capability captures heart images from distances of up to 120 mm. According to LUMA, it enhances heart navigation and visualization with improved depth and clarity during procedures such as structural heart and electrophysiology interventions.
It also removes the need for external imaging systems like X-ray or CT scanners.
Related: HeartBeam’s Credit Card-Sized Cardiac Monitor Cleared for At-Home Use
Impact and Next Steps for LUMA Vision’s Verafeye
Verafeye includes a software interface that integrates seamlessly into existing cath lab workflows.
LUMA Vision says the FDA clearance of the Verafeye platform marks a major advancement in enhancing procedural workflows and expanding the use of innovative technologies that rely on precise visualization.
It delivers real-time, volumetric heart images alongside magnetic navigation and offers interactive guidance to help clinicians make more informed decisions. This capability may shorten procedure times and reduce risks.
“We are incredibly proud of this achievement and the potential impact Verafeye will have in areas such as cardiac arrhythmias, left atrial appendage closure and structural heart. Our team and partners have worked tirelessly alongside clinicians to develop a product that can be the future of cardiac navigation, and this FDA clearance is a testament to their dedication and expertise,” said LUMA Vision CEO Fionn Lahart in the announcement of the FDA clearance.
He said the company looks forward to the difference the platform will make in the lives of both patients and healthcare providers.
The Verafeye system is the company’s flagship product.
The company is also planning future applications for Verafeye beyond electrophysiology, including transcatheter valve procedures and other structural heart interventions.
With the FDA clearance, LUMA Vision positions itself as a key player in the fast-growing intracardiac imaging space.
To support the FDA clearance and upcoming commercialization of Verafeye, LUMA Vision completed a $22 million Series A3 financing round in 2023. The round included investments from EQT Life Sciences, ABV Uni Fund, imec.xpand, Atlantic Bridge Growth Fund and Bayern Kapital.
Meanwhile, Johnson & Johnson’s Shockwave Medical enrolled its first patient this month in a pivotal investigational device exemption (IDE) study. The study will evaluate the Javelin coronary intravascular lithotripsy catheter for the treatment of calcified coronary lesions that are “difficult‑to‑cross.”
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