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- FEMTECH

Mammotome Secures FDA Clearance for Industry-First, In‑Room MR Vacuum‑Assisted Breast Biopsy System and New HydroMARK™ Plus MR Biopsy Site Markers

CINCINNATI, March 18, 2026 /PRNewswire/ — Mammotome, a Danaher company, announces FDA Clearance of two innovations for MR-guided breast biopsy: the Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System – the industry’s first solution designed to be positioned in the MRI scanner room at the patient’s side – and the HydroMARK™ Plus Breast Biopsy Site Marker for MR, engineered for exclusive use with the Mammotome Prima™ system universal targeting set. Following a successful debut of the Mammotome Prima™ MR system in Europe, both products will be introduced to U.S. clinicians at the 2026 Society of Breast Imaging (SBI) Symposium. By bringing the device directly into the scanner room, the Mammotome Prima™ MR system enhances clinician coordination, streamlines communication, and helps maintain consistent focus on the patient throughout the procedure.

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Asieris: CEVIRA Approved in China as First-in-Class Non-Invasive Therapy for Cervical Precancerous Lesions

OSLO, Norway, March 3, 2026 /PRNewswire/ — Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that its core product APL-1702 (trade name: CEVIRA®), has received the Drug Registration Certificate from China’s National Medical Products Administration (NMPA), enabling commercial launch in China.

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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.

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