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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / P250026

PMA approved

Atellica IM free PSA II (fPSAII)

Siemens Healthcare Diagnostics, Inc. · May 11, 2026 · P250026

FDA approved the Atellica IM free PSA II (fPSAII) from Siemens Healthcare Diagnostics, Inc. on May 11, 2026 under P250026, an original premarket approval. The device falls under product code MTG, Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions as a Class 3 device. The review panel was Immunology.

FDA logged the submission as received on Jul 18, 2025. The decision came 297 days later.

Siemens Healthcare Diagnostics, Inc. has 8 other decisions in the tracker over the last 12 months: K253985 (INNOVANCE® D-Dimer 2.0 (SMN 10873803)), K253528 (Atellica IM CA 19-9 II), K261364 (Atellica CH Acetaminophen 2 (ACTM)), K253264 (myAblation Guide (VC10A)).

Questions & Answers

What did FDA approve under P250026?

P250026 is the FDA PMA for Atellica IM free PSA II (fPSAII), submitted by Siemens Healthcare Diagnostics, Inc.. FDA's decision date was May 11, 2026, under product code MTG (Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions).

Who makes the Atellica IM free PSA II (fPSAII)?

Siemens Healthcare Diagnostics, Inc., based in Tarrytown, NY, is the applicant of record for P250026.

How long did the P250026 review take?

FDA received the submission on Jul 18, 2025 and issued its decision on May 11, 2026, 297 days later.

← All decisions in May 2026