What are the specific regulatory pathways available for breakthrough medical devices?

Aug 12, 2021 ... When a medical device is cleared, this means it has undergone a 510(k) submission, which the FDA has reviewed and provided clearance. For Class ... Jan 17, 2023 ... Henry further said it's important to keep in mind that the definition of “recall” is broad and doesn't necessarily mean a product was so ... Mar 21, 2022 ... Developing a new medical device? Here's how much time and cash it could take to get FDA 510(k) clearance or De Novo classification. Apr 2, 2024 ... "Olympus is your trusted stone management partner and now is positioned to provide access to a broad range of high-quality ureteroscopes, ... Nov 22, 2024 ... The US Food and Drug Administration (FDA) 510(k) clearance of remote scanning and remote protocol adjustment features on Philips Radiology Operations Command ... Feb 7, 2024 ... One crucial milestone for many health apps is obtaining 510(k) clearance from the US Food and Drug Administration (FDA). But what exactly does ... Oct 1, 2024 ... ... (FDA) for its PlaqueIQ™ imaging analysis software to help physicians diagnose cardiovascular disease (CVD). PlaqueIQ is the first FDA-cleared ... May 29, 2024 ... This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a ... Jan 7, 2025 ... This new, 25-gauge 180-mm Smart Tip will allow for the treatment of deeper nerves, such as the medial branch nerve and is specifically designed so that it can ... Apr 17, 2025 ... This 510(k) clearance is a testament to years of effort, and we are excited to bring this groundbreaking technology to physicians and their ...