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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 / September 2025 / P240008

PMA approved

saypha® MagIQ

Croma-Pharma GmbH · Sep 8, 2025 · P240008

FDA approved the saypha® MagIQ from Croma-Pharma GmbH on Sep 8, 2025 under P240008, an original premarket approval. The device falls under product code LMH, Implant, Dermal, For Aesthetic Use as a Class 3 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 27, 2024. The decision came 530 days later.

Croma-Pharma GmbH has one other decision in the tracker over the last 12 months: P250021 (saypha® ChiQ).

Questions & Answers

What did FDA approve under P240008?

P240008 is the FDA PMA for saypha® MagIQ, submitted by Croma-Pharma GmbH. FDA's decision date was Sep 8, 2025, under product code LMH (Implant, Dermal, For Aesthetic Use).

Who makes the saypha® MagIQ?

Croma-Pharma GmbH, based in Leobendorf, is the applicant of record for P240008.

How long did the P240008 review take?

FDA received the submission on Mar 27, 2024 and issued its decision on Sep 8, 2025, 530 days later.

← All decisions in September 2025