Executive Exclusives

Now that the US FDA has published its final rule regulating lab developed tests, litigation challenging the rule and the FDA’s authority to enact it is sure to follow. And the central argument will likely focus on whether the tests are defined as medical devices, which the agency regulates without question.

Johns Hopkins professor Tinglong Dai says a subscription model for AI is the most sustainable model for reimbursement. 

The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.

Data privacy lawyer says the comprehensive, bipartisan law is “catching a lot of people’s ears.”

The US FDA’s new initiative to create an idea lab for medical device use at home will benefit device manufacturers, patients and policymakers alike.

Small sterilizers told Medtech Insight that they were ready for the EPA’s controversial EtO emissions rule, while community advocates expressed concerns.

It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.

Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.

A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.

Theradaptive, which makes a device-biologic combination product to help speed bone healing, recently got authorization to start human trials from the US FDA. Medtech Insight spoke to CEO Luis Alvarez about the company’s past, present and future.

Philips CEO Roy Jakobs talks to Medtech Insight about the medtech firm’s decade-long history of embedding AI into its products and what he expects from the newly released draft framework by the National Academy of Medicine, which he helped develop as co-chair of the Steering Committee.

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

Errors or omissions are commonplace when sponsors write their clinical investigation plans. Good signposting is urgently needed. Industry expert Maria Donawa gave some useful tips in how to best read the latest EU clinical trials guidance.

Jasmine Balloch, chief of staff at generative AI medtech startup Tortus, reflects on opportunities for women to succeed and repackage success, providing advice on how to succeed as a woman in medtech.

Medical device cybersecurity is a part of a larger ecosystem that should not—and cannot—be ignored.