US FDA

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.

The US FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee convened Wednesday to discuss germicidal ultraviolet (GUV) devices as a mode of disinfection, a technology that has emerged since the COVID-19 pandemic.

Freenome will combine with Perceptive Capital Solutions Corp in a SPAC deal worth $330m. The goal is to advance Freenome’s blood-based tests for early detection of cancer and, in 2026, launch its advanced colorectal cancer detection test SimpleScreen, currently under FDA review.

The US FDA is launching a pilot to promote access and safety to digital health devices. Developed by the agency’s device center, the pilot will evaluate a new, risk-based enforcement approach for certain types of digital devices to treat several conditions.

The US FDA says Olympus has updated its instructions for a device used in many endoscopic procedures after reports of serious injuries. The class I recall follows the FDA blocking imports of other scoping devices from the Japanese firm earlier this year.

Medtronic won FDA clearance for its Hugo surgical robot for urologic procedures, which Wiliam Blair analyst expects will draw interest from physicians. But he also says that Intuitive Surgical will remain the clear dominant player.

Pending legislation in the US House of Representatives would allow Medicare patients to benefit from some of the latest and most innovative technologies. The bipartisan bill would establish a clear pathway for reimbursement for algorithm-based healthcare services approved by the FDA.

Truvian reached a major milestone with the FDA clearance of its blood-testing benchtop but is awaiting further FDA clearances of blood panels before a full launch in the second half of 2026.

With the roll out of agentic AI, the US FDA continues to expand AI capabilities across the agency. The latest AI deployment follows the agency’s May launch of Elsa, its generative AI tool, which marked ‘the dawn of the AI era’ at the FDA.

In September, the US FDA asked the public to weigh in on how AI-enabled medical devices perform in real-world settings. With the comment period now closed, the agency has heard back from dozens of stakeholders on how the agency can use clinical outcomes to better understand these devices.

Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.

A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.

Hallucinations are a common problem in AI and pose significant challenges to medical devices powered by the technology. A paper authored by several FDA staffers argues that focusing on how hallucinations impact patients is the best approach.

Brain-computer interfaces advance toward trials and commercialization, Oura pushes for FDA-cleared blood pressure monitoring, and regulators weigh AI’s expanding role in mental health and diagnostics amid rising safety concerns.

Data from Medicare patients shows no increased death risk for peripheral arterial disease patients treated with drug-coated devices, easing concerns that once led FDA to discourage use of the products. Researchers say the study could be a model for future large-scale cardiac device safety trials.

The US FDA has issued a draft guidance document to help device manufacturers navigate the new Quality Management System Regulation (QMSR) concerning premarket approval applications and humanitarian device exemptions applications. The new regs take effect in February.

Tandem Diabetes Care is positioning for growth in 2026 with the launch of its Mobi Tubeless pump following FDA clearance of its Android-compatible Mobi app while navigating multiple recalls during what CEO John Sheridan called a transformative year.