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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.
You can also try our MedExplorer, a self-assessment tool that helps medical technology companies estimate their FDA application status (especially for 510(k)), explore possible new features, evaluate product competition, seek company partnership opportunities, and obtain potential manufacturing improvement information.
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".