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  1. 2024 Device Approvals | FDA

    Aug 1, 2025 · The products listed in this section include some of the newest medical technology from the year 2024.

  2. FDA panel votes against approving first-of-its-kind heart failure device

    6 days ago · All 15 members of the FDA's Circulatory System Devices Panel agreed that more data is required to confirm the new device from Johnson & Johnson MedTech is effective. Will …

  3. May 19, 2025 · This report also provides an overview of the FDA centers responsible for regulating medical device and drug products, brief summaries of the FDA’s approval …

  4. 2024's Medical Innovations: FDA-Cleared and Approved Devices

    Dec 20, 2024 · Explore the latest medical technologies approved in 2024, transforming treatment and diagnostics. The year 2024 witnessed remarkable advancements in medical technology, …

  5. Recently-Approved Devices | FDA

    Feb 13, 2024 · PMA Approvals: Listings of all new or high-risk medical devices that were approved via the premarket approval (PMA) pathway.These devices require a more rigorous …

  6. FDA grants IDE approval to EyeYon Medical for its US clinical …

    1 day ago · The US Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to EyeYon Medical for its US clinical study of EndoArt, which is …

  7. FDA's novel medical device clearances slow to a crawl

    Mar 27, 2025 · According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light …

  8. Medical Device FDA Approval Process [+Timeline]

    Nov 18, 2024 · The approval process for medical devices in the US will vary depending on the risk classification of your device. Here’s what you need to know.

  9. Upcoming FDA Approvals & Decisions - May 2025 - Guideline …

    Apr 30, 2025 · A list of the anticipated FDA approvals for pharmaceuticals and medical devices in the month of May 2025.

  10. FDA Alerts: Ophthalmology Drug and Device Approvals

    Jan 15, 2025 · FDA alerts and updates on the latest drug and device approvals, recalls, and other regulatory developments in ophthalmology.