Jeff Shuren, who has been the head of the Food and Drug Administration’s Center for Devices and Radiological Health since 2009, is leaving his position. While he has been successful in earning the trust of the medical device industry, there have been concerns about risky products slipping through the cracks, like the Philips sleep apnea machines recalled in 2021. Shuren’s departure has left the medical device world stunned.
The FDA has recently formed its first advisory committee for digital health, which includes industry experts and will address issues related to generative AI-enabled medical devices. This committee aims to advise the FDA on digital health issues and regulations. Additionally, private sector leaders from companies like Abbott, Medtronic, and Boston Scientific will represent the digital health industry’s interests on the committee.
A study has highlighted the risks associated with weight loss drugs sold online without prescriptions. Some illegal online pharmacies are selling compounded medicines that may contain more of the drug than labeled and could even have bacterial contamination. This poses a significant risk to consumers who purchase these products online without a prescription.
Hims & Hers, a direct-to-consumer business in the virtual care industry, has exceeded Wall Street expectations and raised its revenue outlook. With a significant increase in net new subscribers and revenue growth, the company is gaining traction in the GLP-1 market. Analysts believe that the launch of compounded GLP-1s could further drive revenue growth for the company.
The board of directors at 23andMe has rejected CEO Anne Wojcicki’s proposal to take the company private. The board determined that the proposal did not offer a premium to the current stock price and lacked commitments from other investors. However, Wojcicki has been given additional time to submit a revised proposal that aligns with the board’s expectations.
The Health and Human Services Department has posted a notice regarding a cyberattack on Change Healthcare, which affected a significant number of individuals. While the exact number of affected individuals is still being determined, the cyberattack has raised concerns about data security in the healthcare industry.
A new analysis led by health tech startup Waymark raises questions about whether cost-effectiveness analyses disadvantage marginalized groups. The analysis suggests that standard methodologies for demonstrating value may not accurately reflect the cost-savings and effectiveness of interventions for certain populations. This highlights the need for a more inclusive approach to cost-effectiveness analyses in health policy decisions.
As technology continues to transform the healthcare industry, it is essential to address these emerging challenges and ensure that regulatory agencies are equipped to deal with the evolving landscape of digital health. The formation of advisory committees and the scrutiny of cost-effectiveness studies are crucial steps in ensuring the safety and effectiveness of medical devices and treatments in the digital age.
