Both legacy players and startups have an important role to play when it comes to medical innovation—they need to work together to meet the increasing demand for minimally invasive treatments, value-based care and innovative, not incremental therapies. This is a mutually beneficial relationship that is key to medical technology development.
How can AI become a beneficial medical device manufacturing technology? This article reviews some examples of how it excels.
The long-awaited part 23 of ISO 10993, the series of standards governing Biological Evaluation of Medical Devices, was published in January 2021. It was the first to introduce validated methods for in-vitro irritation tests. This article reviews the latest developments and identifies the cases in which manufacturers can avoid animal experiments.
Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks), effective (performing as expected), and state of the art (compared to industry benchmarks).
Russia’s invasion of Ukraine has increased the potential for cyberattacks against U.S. healthcare systems.
Building fruitful development partnerships between companies, governments and researchers will enable the most promising and impactful deployments in healthcare.
A global pandemic is still upon us, but that certainly does not mean that healthcare technology innovation is standing still. To help the medical device industry look to the future and prepare, experts from regulation and academia alike are bringing attention to the acceleration and pitfalls of innovation.
Although the future is exciting, it also poses real challenges. More collaborative initiatives need to take place between drug manufacturers and developers of manufacturing equipment and consumables.
The test detects all known variants of SARS-CoV-2, including alpha, beta, gamma and omicron.
The Class I recall affects more than 95,000 devices in the United States.
