UK-based Ultromics announced it received FDA Breakthrough Device Designation for an AI tool that aims to detect cardiac amyloidosis.
The platform, called EchoGo Amyloidosis, analyzes echocardiograms to find signs of the condition, where the protein amyloid builds up in the heart and limits function. Though the designation isn’t a marketing approval from the FDA, it aims to accelerate review of products that could help treat debilitating or life-threatening conditions.
Ultromics said the tool is intended to be used with the company’s EchoGo Platform and was developed with support from Janssen Biotech. The company said it’s currently working on a regulatory submission and the tool could be approved by early 2024.
Earlier this year, Ultromics received FDA 510(k) clearance for EchoGo Heart Failure, which was developed in partnership with the Mayo Clinic to help detect heart failure with preserved ejection fraction.
“This is our second breakthrough designation and brings us one step closer to achieving our goal of providing earlier and more accurate diagnosis for this debilitating, underdiagnosed disease. We are excited to continue working with our partners to bring this technology to market and help improve outcomes for patients,” Dr. Ross Upton, CEO and founder of Ultromics, said in a statement.
Click Therapeutics has begun enrolling patients in a clinical trial studying its prescription digital therapeutic for episodic migraine.
The decentralized and remote trial — called ReMMi-D, the Reduction in Monthly Migraine Days study — will enroll about 558 patients in the U.S. The study will deliver the therapeutic over 12 weeks and evaluate the difference between groups in the number of monthly migraine days.
Click received FDA Breakthrough Device Designation for the therapeutic as an adjunctive preventive treatment for episodic migraine in adult patients late last year.
“Our team has worked diligently to develop this groundbreaking technology and we are excited to be at the forefront of medicine’s digital revolution,” Han Chiu, chief technology officer of Click Therapeutics, said in a statement. “We believe that our platform-based approach harnessing the power of data, AI, and exceptional product design will lead to a best-in-class treatment for migraine that can improve the lives of patients worldwide.”
Digital Diagnostics is partnering with Labcorp to offer its AI-backed diabetic retinopathy screening in nine of the diagnostic giant’s patient service centers in Alabama.
LumineticsCore, formerly called IDx-DR, analyzes retinal images to detect diabetic retinopathy, which can cause vision loss and blindness in people with diabetes. The product received FDA De Novo clearance in 2018.
“This strategic relationship with Labcorp to bring LumineticsCore to their patient service centers aligns with their mission to improve health and improve lives,” Seth Rainford, Digital Diagnostics’ cofounder, president and COO said in a statement. “Offering this important exam in locations that are easily accessible, coupled with our mission to work with the healthcare ecosystem, furthers our collective goal of improving patient outcomes.”