Latest News
4 April
AdvaMed CEO calls for medtech industry to be exempt from Trump tariffs
The 10% baseline tariffs come into effect 5 April, while those of varying ranges will take force on 9 April. Credit: Oleg Elkov / Shutterstock
Whether or not an ally of the US, President Trump has moved to impose tariffs on multiple countries, including all trade partners, in an action expected to stoke a global trade war.
Some countries, including the UK, Australia, and Saudi Arabia, will face only a ‘base line’ tariff of 10%, due to go into effect on April 5. Other countries, including the European Union (EU) as a collective, Japan, and China are facing tariff rises of 20%, 24%, and 54% (including earlier tariffs) respectively, which will go into effect 9 April.
The Advanced Medical Technology Association (AdvaMed) highlighted that it supports “any and every” policy that allows the US to maintain its position of global primacy in “every aspect of medical innovation imaginable”, adding that it “fully supports” the President’s goal of moving as much manufacturing into the US as possible.
Whitaker went on to emphasise that AdvaMed intends to continue working with the White House to help it to understand the important role the medtech industry plays in the US’s health care ecosystem, and the overall importance of the industry towards continued US economic growth.
Whitaker concluded: “The medtech industry should be exempted from these tariffs.”
1 April
FDA’s LDT rule struck down in Texas court
A Texas judge has ruled against the US Food and Drug Administration (FDA) in a court case that challenged the agency’s plans to regulate laboratory-developed tests (LDTs) – defined as in vitro diagnostics (IVD) products – as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).
Filed by the American Clinical Laboratory Association (ACLA), member company HealthTrackRx, and the Association for Molecular Pathology (AMP) at the US District Court for the Eastern District of Texas in 2024, the lawsuit asserted that the use of the medical device framework as mooted in the FDA’s Final Rule was “inappropriate and ill-suited” for regulating LDTs.
Consequently, the plaintiffs’ lawsuit expressed that the FDA’s Final Rule must be vacated under the Administrative Procedure Act (APA) due to it being “in excess of [the FDA’s] statutory jurisdiction, authority, or limitations” and amounted to an “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law”.
4 April
Fear and uncertainty’ linger over FDA’s future in wake of Trump admin’s layoffs
This week, the Trump administration followed through on its plans for mass layoffs at health agencies under the US Department of Health & Human Services (HHS).
Per a communiqué issued by the White House last week, layoffs at HHS departments including the US Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH) would total around 10,000. Including voluntary resignations and retirements, the plans to drive governmental efficiency and ‘Make America Healthy Again’ were projected to reduce the total full-time employees under the combined HHS agencies from 82,000 to 62,000.
Medical device contract research organisation (CRO) NAMSA hosted a webinar on 3 April to discuss the potential impact of the layoffs on the medical device industry.
2 April
Data security ‘most promising application’ of blockchain for medical devices
The most promising use of blockchain technology for medical devices is viewed by industry experts as data security, a new report outlines.
GlobalData’s Blockchain in Medical report in part details the results of a poll carried out by the company in February that found data security to be overwhelmingly considered to be the biggest potential benefit among five main possibilities. Well over a third (38%) of the 212 respondents indicated that ensuring safe and tamper-proof patient data storage through data security was the most promising application, with enabling seamless data exchange through interoperability next on 22%.
A little shy of a fifth (18%) of respondents suggested that tracking devices from manufacturing to deployment for supply chain was the most promising application, 15% said verifying the legitimacy of medical devices for device authentication and 7% said automating payments and agreements using smart contracts.
2 April
RFK Jr swings axe at US health agencies
Since Trump’s return as president, the Elon Musk-helmed Department of Government Efficiency (DOGE) has been making cuts to US Government departments, beginning with the culling of employees at the US Agency for International Development (USAID) in February. Now, the US Department of Health & Human Services (HHS) is on the chopping block.
Under plans outlined by HHS Secretary Robert F Kennedy, Jr (RFK Jr), thousands of employees at the health agencies under the HHS received notices on 1 April that their jobs were being eliminated.
Last week, under a transformation plan touted to ‘Make America Healthy Again’, the White House revealed plans to cut around 10,000 employees from HHS departments, including the US Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH)