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Newsletter on MedTech and FDA

Our monthly MedExplorer newsletter can help you predicate 510k clearance time and explore new MedTech features for your next iteration in product development.

If you want to have more information to optimize product design and FDA pathways, please contact us at contact@buttontech.us.

On December 30th 2022, Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) got 510K cleared. This newsletter summarizes the latest 510K clearance time estimation and lists potential new features for medical devices with Product Code "ODG".

On October 7th 2022, RespiraSense (Product Code: BZQ) from PMD Solutions got 510K cleared. This newsletter summarizes the latest 510K clearance time estimation and lists potential new features for medical devices with Product Code "BZQ".

On August 31st , Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 (Product Code: "MUH") from RealCloud Imaging Inc got 510K cleared. This newsletter summarizes the latest 510K clearance time estimation and lists potential new features for medical devices with Product Code "MUH".

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