We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A top benefit of the Case for Quality Voluntary Improvement Program (VIP) for medical devices — a collaborative initiative formally recognized by the FDA in recent weeks — is to give devicemakers a way to get the FDA’s help with quality measures that go beyond regulatory compliance. Read More
Abiomed received a warning letter for its Impella Connect System for failing to have an approved application for premarket approval or an investigational device exemption, according to the FDA’s warning letter. Read More
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on what to expect from the FDA in 2024, quality culture and how to use UDI and UDI Data. Read More
The FDA has created the new Digital Health Advisory Committee to help the agency explore the complex issues related to artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software as well as decentralized trials, patient-generated health data and cybersecurity. Read More
Most predictive clinical decision support devices (CDS) that rely on machine learning (ML) or AI are approved and marketed without adequate proof that they deliver on their promise of improving outcomes for patients with critical illnesses, a study has found. Read More
HistoSonics’ Edison System, which uses focused ultrasound to mechanically destroy and liquify unwanted liver tissue and tumors, has received de novo marketing authorization from the FDA and is the first histotripsy platform available in the U.S. Read More
Guidance updates, Novo Nordisk complaint against semaglutide compounders tossed, and AdvaMed forms new digital tech division, in this edition of Quick Notes. Read More
The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of AI/machine learning (ML) and increased collaboration between the agency and industry. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More