ce-mark

(3)
Company
Pearl Diagnostics, Inc.
Health · Hardware · Enterprise

Pearl Diagnostics, Inc.

Pearl Diagnostics is a Baltimore-based in vitro diagnostics company spun out of Johns Hopkins University that develops non-invasive urine tests to detect life-threatening lung infections. Its proprietary Smart Antibody technology identifies circulating microbial extracellular vesicles, and its lead product, the MycoMEIA Aspergillus Assay, became the first urine-based test to win FDA 510(k) clearance for aiding diagnosis of invasive aspergillosis. The company raised an $11.2M Series A in March 2026 to commercialize in the US and expand across Europe.

fungal-infection-diagnostics · aspergillosisRead →
Company
Hemanext
Health · Hardware · Enterprise

Hemanext

Hemanext is a Lexington, Massachusetts medical technology company that reengineers how donated red blood cells are stored. Its flagship system, Hemanext ONE, removes oxygen and carbon dioxide from red blood cell units during processing and keeps the environment hypoxic through 42 days of refrigerated storage, slowing the oxidative degradation known as the storage lesion. The system carries FDA marketing authorization (originally via the De Novo pathway) and a CE mark, and aims to deliver a higher-quality blood product for patients who depend on transfusion, including those with thalassemia, sickle cell disease, and trauma.

blood-storage · transfusion-medicineRead →
Company
Intalight
Health · Hardware · Ai

Intalight

Intalight is a US-based ophthalmic imaging company (the international brand of SVision Imaging / 视微影像, Luoyang, China) that builds high-speed swept-source OCT and OCT-angiography systems. Its flagship DREAM OCT platform images the whole eye in a single ultra-widefield scan, combining deep retinal penetration, anterior-segment imaging, biometry, and AI-driven segmentation for clinicians and researchers worldwide.

ophthalmology · optical-coherence-tomographyRead →