Blog

- ARTIFICIAL INTELLIGENCE

Perimeter Medical Imaging AI’s ‘Claire’ Becomes First FDA-approved AI-Enabled Imaging Device for Breast Cancer Surgery

TORONTO and DALLAS, March 3, 2026 /PRNewswire/ – Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) (“Perimeter” or the “Company”), a commercial-stage medical technology company, announced today that it has received U.S. Food and Drug Administration (“FDA”) premarket approval (“PMA”) for Claire™ (formerly the Perimeter OCT B-Series with ImgAssist AI 2.0), the first AI-enabled imaging device approved in the United States for intraoperative breast cancer margin assessment.

Read More »

SciBase receives approval by FDA for extended labelling in the US

STOCKHOLM, March 2, 2026 /PRNewswire/ — SciBase Holding AB (“SciBase”) (STO: SCIB), a leading developer of AI-based diagnostic solutions for skin disorders, today announced that it has received approval by FDA for its supplement to extend the labelling to include other healthcare professionals and not only dermatologists to perform the Nevisense procedure

Read More »

Ultrasound AI Receives FDA De Novo Clearance for Delivery Date AI Technology

DENVER, March 2, 2026 /PRNewswire/ — Ultrasound AI, a pioneer in artificial intelligence applications for medical imaging, today announced it has received FDA De Novo clearance for its flagship Delivery Date AI technology, a cloud-based SaMD that determines a Predicted Delivery Date (PDD) solely from standard ultrasound images and seamless integration into current OB/MFM prenatal visit workflows; PDD is provided in real-time for actionable decision-making by the clinical team.

Read More »