Ultromics, a UK-based AI company, has received FDA Breakthrough Device Designation for its EchoGo Amyloidosis platform, which analyses echocardiograms for signs of cardiac amyloidosis. The tool was developed with support from Janssen Biotech and could be approved by early 2024. Click Therapeutics has enrolled patients in a clinical trial to evaluate its prescription digital therapeutic for episodic migraines, ReMMi-D. Digital Diagnostics has partnered with Labcorp to offer AI-backed diabetic retinopathy screening in Alabama. LumineticsCore received FDA De Novo clearance in 2018.
Ultromics, a UK-based company that develops artificial intelligence (AI) tools for cardiac imaging, has announced that its EchoGo Amyloidosis platform has received FDA Breakthrough Device Designation. The platform analyses echocardiograms to identify signs of cardiac amyloidosis, a condition in which the protein amyloid builds up in the heart and limits its function. The designation is not a marketing approval from the FDA, but it aims to speed up the review of products that could help treat debilitating or life-threatening conditions. Ultromics said that 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 is currently working on a regulatory submission and the tool could be approved by early 2024. Ultromics received FDA 510(k) clearance for EchoGo Heart Failure earlier this year, which was developed in partnership with the Mayo Clinic to help detect heart failure with preserved ejection fraction.
ReMMi-D trial:
Click Therapeutics has commenced enrolling patients in a clinical trial studying its prescription digital therapeutic for episodic migraine. The study, called ReMMi-D (Reduction in Monthly Migraine Days), is a decentralized and remote trial that will enroll approximately 558 patients in the United States. The trial will deliver the therapy over 12 weeks and assess 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. The company believes that its 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. Han Chiu, the chief technology officer of Click Therapeutics, said in a statement, “Our team has worked diligently to develop this groundbreaking technology, and we are excited to be at the forefront of medicine’s digital revolution.”
Digital Diagnostics and Labcorp:
Digital Diagnostics has partnered with Labcorp to offer its AI-backed diabetic retinopathy screening in nine of the diagnostic giant’s patient service centers in Alabama. Luminetics Core, 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. Digital Diagnostics’ co-founder, president, and COO, Seth Rainford, said in a statement, “This strategic relationship with Labcorp to bring LumineticsCore to their patient service centers aligns with their mission to improve health and improve lives.” 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”.
