US FDA
The US FDA’s Quality Management System Regulation has officially replaced the decades-old Quality Management System. The new system links with international standards for regulating medical device systems.
The US FDA device center’s new annual report found notable successes in 2025 that included continuing to meet user fee goals as well as making progress on patient safety, innovation, and regulatory science.
The US FDA has granted clearance to eMurmur, broadening the use of its AI-powered software platform. The innovative system identifies primary heart sounds to detect abnormal murmurs as they occur.
The US FDA has published a draft guidance on clinical performance testing and evaluation for premarket submissions from manufacturers of cuffless blood pressure measuring monitors, which the agency generally regulates as class II devices.
As the deadline for the US FDA’s new quality system incorporating international standards fast approaches, the agency held a town hall to offer industry some last-minute tips to get ready for the regulatory framework.
Chatbots can churn out valuable information to patients and give much needed assistance to healthcare personnel. But their mistakes can lead to significant patient harm, which is why ECRI ranks their misuse as the top health technology hazard for 2026.
AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.
The US FDA has issued an early alert concerning some Axios stent and delivery systems used in endoscopic drainage procedures after receiving reports of serious injuries and deaths linked to the device.
The US FDA has updated a pair of guidance documents relaxing the agency’s posture on how it regulates general wellness devices and clinical support software. Industry has mostly welcomed the changes, agreeing with the agency’s view that lighter regulation will help spur innovation.
As medtech moves toward 2026, experts highlight increased regulatory complexities, particularly around AI, cybersecurity, and device user fees. Urgent regulatory updates are needed to keep pace with rapid technology changes while ensuring patient safety and operational efficiency.
Johnson & Johnson is seeking marketing authorization from the US FDA for its Ottava surgical robot for upper abdomen procedures. If granted, Ottava could prove stiff competition for Medtronic and Intuitive.
As our experts know, the geopolitical and macroeconomic uncertainties reshaping the medtech industry make resilience and innovation more important than ever. Companies are onshoring to sidestep supply chain fragility prompts onshoring, while healthcare systems demand proven value.
A pair of diagnostic developers backed with venture capital have teamed up with the University of Tennessee to fight colorectal cancer. The collaboration seeks to advance next generation testing to catch one of the deadliest cancers in its earliest stages.
The FDA’s revised guidance emphasizes biological sex in clinical trials, removing references to gender and health equity considerations.
The FDA and medtech industry held multiple meetings last month to continue talks for the next round of medical device user fee amendments. Stakeholder priorities included resource planning, fee structure reforms, IT enhancements, international harmonization, and real-world evidence.
Last year was a busy one for the medtech industry, with major advances in technology as well as big changes at regulatory agencies. Get a peek at the stories our readers couldn't miss.
The US FDA has made incorporating real-world evidence into medical device decisions a lot easier. The agency now says it will accept RWE without requiring it to contain identifiable individual patient data, making more of it available. Many stakeholders welcomed the change.
As requested by a pair of US senators, the GAO has published a report on how the FDA handles medical device recalls. The review found that the agency lacks the necessary staff and regulatory authority to process recalls safely and effectively.
Rapid advancements in neurotechnology intensify the need for clear regulations concerning neural data privacy. As these technologies evolve at unprecedented speeds, lawmakers, legal experts, and neuroethicists are increasingly focused on their societal impact.
During a webinar hosted by Sedgwick, a pair of regulatory experts discussed how medtech firms can optimize their engagement with the FDA, especially when it comes to communicating recalls and corrective actions.