The amendment introduced to the Ensuring Patient Access to Critical Breakthrough Products Act in the Ways and Means committee markup of helped usher the legislation to a passing vote.
The Ensuring Patient Access to Critical Breakthrough Products Act of 2024 (HR1691) was approved by the US House Committee on Ways & Means on 27 June, supported by an amendment that tightened the criteria for breakthrough devices to be covered by the pathway.
The bipartisan bill, originally introduced by Representatives Suzan DelBene (D-WA) and Brad Wenstrup (R-OH) passed out of committee with a...
A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.
In this week's Digital Health Roundup, Medtech Insight's team discusses progress on autonomous surgery, Medtronic's new partnership with IRCAD, FDA cybersecurity news, and C-suite interviews with OpenWater, Flow Neuroscience and EnsoData.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
