Medical Device Network

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. Addressing the potential impact of the cuts to the FDA’s review and approval process of medical devices, Dr Jeff Shuren, who served as director of the FDA’s Center for Devices and Radiological Health (CDRH) from 2009 until July 2024, said it would “not be surprising” if the cuts resulted in longer device review times, at least in the near term. “One of the challenges moving forward will be to assure that the FDA’s premarket review programme has the expertise that it needs, and that time and attention is put into recruitment and retention.” https://lnkd.in/eBzVYiGk

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). The Trump administration estimated that the cuts, including retirements and voluntary resignations, would result in a culling of the combined agencies’ workforce from 82,000 full-time employees to 62,000. AFGE national president Everett Kelley lambasted the HHS agency cuts, branding them “dangerous, irresponsible, and unacceptable”. In a similar vein, the Infectious Diseases Society of America maligned the job cuts, stating that “we cannot do the complex and serious work of protecting Americans from infectious diseases amid this chaos and confusion” and concluding that the actions were “counter” to the goal of keeping America healthy. https://lnkd.in/evwWhXnr

Swiss-based SHL Medical has opened a new autoinjector manufacturing facility in North Charleston, South Carolina, US, with a $220m investment. SHL Medical chairman and CEO Ulrich Fässler said: “US-based production is a major step forward in our global expansion and reinforces our position as the leader in providing end-to-end drug delivery solutions. With our established site in Taiwan and the upcoming facility in Switzerland, we will be the only autoinjector manufacturer operating across three continents, bringing us even closer to our customers.” Click here for the full article - https://lnkd.in/d3B9qaJs #medicaldevice #medtech #drugdelivery #autoinjector #medicaldevicemanufacturing

GlobalData Healthcare forecasts that the global blockchain software and services market will reach $291bn in 2030, up from $12bn in 2023. 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%. Click here for the full article - https://lnkd.in/duDzeGcW #medicaldevice #medtech #blockchain #datasecurity

https://lnkd.in/eedCNxNE A Texas judge has struck down the FDA's planned rule to regulate laboratory-developed tests (LDTs) in the same way as medical devices. Commenting on the success of its lawsuit, American Clinical Laboratory Association (ACLA) president Susan Van Meter said: “The court’s ruling ensures that clinical laboratories can continue to focus on their primary mission – offering innovative and reliable diagnostics that save and improve the lives of millions of patients every day. “This is a victory that protects patient access to critically needed testing services and removes burdensome regulations that would have undermined the clinical laboratory system in this country.”

GE HealthCare is rolling out a new computed tomography (CT) system to support practitioners in diagnosing complex coronary artery disease (CAD) cases. Jean.luc Procaccini, president and CEO of molecular imaging and computed tomography at GE HealthCare, commented: “Expanding access to CCTA is crucial for managing the rising prevalence of CVD, ensuring timely and accurate diagnoses for a larger patient population. Our introduction of Revolution Vibe underscores our commitment to this mission.” Click here for the full article - https://lnkd.in/dM7XEGdN #medicaldevice #medtech #medicalimaging #medicaltechnology

Swedish company Sigrid Therapeutics ’s weight loss product has been recognised by the US Food and Drug Administration as a medical food. Speaking with Medical Device Network, co-founder & CEO of Sigrid Therapeutics, Sana Alajmovic, detailed how it is looking to take a piece of the market left behind by traditional GLP1 therapies. Click here or the full article - https://lnkd.in/dGDg8ymP #medicalfood #GLP1 #weighlossdrugs #obesity

Although AI chatbots promise to change every aspect of psychological therapy, AI lacks the emotional intelligence and empathy of human therapy. Click here for the full article - https://lnkd.in/d_uVfFMH #medicaldevice #medtech #mentalhealth #ai #chatbots

GE HealthCare’s newest offering from its automated ultrasound system line represents a significant advancement in breast cancer screening, according to market analysis. Graysen Vigneux, PhD, Medical Analyst at GlobalData Healthcare, comments: “For patients with dense breast tissue, where mammography alone may be insufficient, [GE HealthCare’s technology] provides a critical additional layer of detection, improving diagnostic accuracy and potentially saving lives.” Click here for the full article - https://lnkd.in/d4CEVg2z #medicaldevice #medtech #medicalimaging #oncology #breastcancer