Blog

- March 18, 2026

DCwire® Micro Guidewire Receives FDA 510(k) Clearance, Marking a Key Milestone in Peijia Medical’s Global Expansion

SUZHOU, China, March 18, 2026 /PRNewswire/ — Peijia Medical (9996.HK), a leading Chinese domestic company in the high-growth transcatheter valve therapeutics and neurovascular interventions markets, announced that its DCwire® Micro Guidewire has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) on March 17, 2026. The product was independently designed and developed by Achieva Medical Limited, a subsidiary of the Company.

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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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Spinal Elements Expands Ventana® Platform with FDA 510(k) Clearance and First Cases of Ventana® A ALIF System

CARLSBAD, Calif., March 18, 2026 /PRNewswire/ — Spinal Elements®, a spine technology company known for developing innovative surgical solutions that prioritize clinical performance and surgical efficiency, today announced 510(k) clearance from the FDA and the first cases using its Ventana A Anterior Lumbar Interbody Fusion (ALIF) System. Ventana A strengthens Spinal Elements’ family of 3D printed titanium interbodies for lumbar and cervical fusion and is being introduced through a limited market launch.

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