The medical imaging industry has seen a rise in revolutionary technology that is changing our processes going forward. In this article, we examine the ongoing events making the biggest impact on the medical imaging industry in 2024.
Trends Shaping The Medical Imaging Industry in 2024
1. Medical Imaging Product Recalls
In 2023, the FDA’s series of medical device product recalls served as a glaring indicator that deeper issues may be at play within the industry. Congress has responded by calling for thorough investigations by the FDA, recognizing that the recalls represent just the tip of the iceberg in terms of potential challenges. The scrutiny and investigations are expected to shed light on systemic issues, potentially triggering further recalls as regulatory bodies aim to ensure the safety and efficacy of medical devices. This heightened focus on oversight underscores the urgency of addressing underlying concerns to prevent potential risks to public health.
The most alarming trend surfaces with the repeated medical device recalls related to Philips Healthcare products. Between July 2021 and December 2023, the FDA recalled a total of 14 medical device models produced and sold by Philips Healthcare, impacting millions of patients. The repercussions extend beyond product retrieval, delving into ongoing litigation and settlements, casting a shadow over the healthcare giant.
In 2024, as Congress pushes for FDA investigations, a Senator calls for DOJ action against Philips’ parent company. Independent investigations revealed Philips allegedly concealed over 3,700 complaints about faulty medical devices.
- https://www.propublica.org/article/philips-kept-warnings-about-dangerous-cpaps-secret-profits-soared
This sets the stage for an unfolding series of investigations and litigations in 2024. Amidst these revelations, the spotlight on transparency and accountability in the healthcare industry intensifies. As legal battles unfold, a new frontier emerges: the realm of Medical Device Right-to-Repair Litigation, where the pursuit of repairability and patient safety takes center stage.
2. Medical Device Right-To-Repair Litigation
Medical device right-to-repair litigation is evolving as major medical imaging device manufacturers, known as OEMs, unite within the AdvaMed (Political Action Committee Profile). This follows a significant case in 2023, where OEM’s brought a suit against multiple independent service organizations, evident in the Philips v. TEC Holdings case.
In October 2021, a DMCA exemption was issued by the Library of Congress, permitting Independent Service Organizations (ISOs) access to medical system software for service and repair, categorizing it as fair use. This led to to an unsuccessful suit brought against the Library of Congress by Medical Imaging and Technology Alliance.
Although OEMs appear resistant, they may be facing challenges, as the groundwork is laid for innovation and change. Overall, this on-going litigation could slow down progress in the industry, delaying the integration of emerging technologies and services intended to enhance the healthcare sector.
3. AI in Radiology
The FDA has cleared over 700 AI-enabled medical devices, underscoring the significant impact this radiology trend is poised to have on the medical imaging industry in 2024. AI is facilitating improvements in workflow optimization and enhanced imaging capabilities, empowering imaging centers to optimize diagnostic tests. Expect to see further updates in this arena. Click here to see the entire list of FDA Cleared AI-Enabled Medical Devices.
4. Emergence of New Medical Imaging Companies
While the “Big 4” (GE, Siemens, Toshiba, Philips) have traditionally dominated the medical imaging industry, emerging companies such as Canon and United Imaging are gaining prominence. Notably, these companies are integrating cutting-edge technology with a sustainable design. This approach leads to lower medical device cost-to-install, seamless upgradeability for new technology, and subsequently, reduced costs for patients without compromising safety. Undoubtedly, this shift is poised to reshape the medical imaging market as customers increasingly look for long-term imaging solutions.
5. Medical Imaging Safety Reporting
In 2023, a significant surge in reported MRI accidents brought attention to a deficiency in safety reporting systems. While notable MRI accidents typically dominate social media and news headlines related to MRI safety, it helps to draw a renewed focus of existing MRI safety reporting guidelines.
Despite the FDA’s requirement for prompt reporting of MRI accidents, the industry is gravitating towards more comprehensive solutions. 2024 will see the emergence of independent safety reporting agencies, dedicated to creating data-rich safety reports for all scenarios. The overarching objective is to amass valuable data on accidents, fostering industry changes that enhance patient safety.
Conclusion
The evolving landscape of the medical imaging industry introduces a transformative phase in diagnostic testing policy. While the extent of the impact remains uncertain, it is evident that these changes will significantly influence the industry going forward. The incorporation of state-of-the-art technology and sustainable design may bring about shifts in costs and accessibility, with potential implications for patients. As these developments unfold, you can expect further updates into this subject matter. Only time will reveal whether the overall impact will be positive or negative for the medical imaging industry.