Biomed Brilliance, Edition 18: The New Year

This is the first edition of Biomed Brilliance in 2025, and I want to take a moment to wish you, all a happy (belated) new year!

As we start the closing year of the first quarter of this century (!), I think it’s a perfect time to reflect on how far we’ve come and look ahead to the incredible potential the next quarter (2026-2050) holds. Think of it like finishing the first chapter of a book, a chapter filled with growth, innovation, and possibility. Now, it’s time to set the stage for what’s next.

My outlook for 2025 is that it’s a time for bold dreams and decisive action (and a whole lotta AI)! So, let’s finish this chapter strong and launch into the next with unstoppable momentum. Here’s to making 2025 a year of brilliance and setting the tone for an even brighter future.

Before diving into the core content of this newsletter, allow me to cover a bit of 'housekeeping' to set the stage for 2025. As you know, Biomed Brilliance started as a biweekly newsletter, but moving forward, I’ll publish one edition per month. The focus will remain on biomedical engineering, innovation in medical devices, and patient safety. I’ll keep the content concise and to the point. After all, in today’s fast-paced world, who has time for long reads, right?

Lastly, I plan to go LIVE more often on LinkedIn, sharing content on joint pain/surgery which would be suitable for everyone, as well as topics tailored to graduate and junior biomedical engineers in the medical device industry (MedTech). So, let me know if you are an industry expert interested in collaborating on the LIVE sessions. Feel free to drop a comment or send me a private message. Let’s start planning for an impactful 2025 together!

Regulatory Updates in 2025: Recent FDA Approvals and Changes in CE Marking Requirements for Medical Devices

In January 2025, the FDA approved a combination therapy developed by 安进 , comprising LUMAKRAS? (sotorasib) HCP and Vectibix, for treating metastatic colorectal cancer in patients with a specific KRAS gene mutation. This approval also included a diagnostic device from 凯杰 to identify suitable patients for this therapy. The combination demonstrated an extension in progression-free survival to 5.6 months compared to two months with standard care. [Reuters]

Additionally, the FDA 's Center for Devices and Radiological Health (CDRH) released its 2024 Annual Report, highlighting significant actions taken to advance safe and effective medical devices. The report underscores efforts to improve device safety and foster the development of devices addressing unmet medical needs. [U.S. Food and Drug Administration]

Note that, the FDA is interested in hearing from health care facilities and providers that may be having difficulty obtaining medical devices, as well as from other interested parties who may be impacted by potential shortages. Please email the FDA at [email protected].

CE Marking Requirements in the European Union

The European Union 's Medical Device Regulation (EU MDR), which came into full effect in 2021, continues to impact medical device manufacturers. The MDR emphasises specific requirements for clinical evaluation, post-market surveillance, and increased transparency. Manufacturers must ensure compliance with these regulations to obtain and maintain CE marking for their devices. European Medicines Agency (EMA)

Furthermore, the MDR has introduced reclassification of certain devices, necessitating manufacturers to reassess their product portfolios and possibly undergo additional conformity assessments. This process often involves collaboration with notified bodies designated by EU member states to conduct these assessments. Public Health

This Edition’s Highlighted Video

Coronation Street legend Bev Callard shares her struggle to walk again after a failed hip operation. Watch her full story now!

Follow @Shahrzad_Biomed_Eng and subscribe to @ShahrzadShariat for more videos!

Quiz: Regulatory Updates in 2025

1. What recent FDA-approved combination therapy is used to treat metastatic colorectal cancer with a specific KRAS gene mutation?

A) Keytruda and Avastin

B) LUMAKRAS? (sotorasib) HCP and Vectibix

C) Opdivo and Yervoy

D) Herceptin and Perjeta

2. What is one key focus of the FDA's Center for Devices and Radiological Health (CDRH) in its 2024 Annual Report?

A) Reducing the cost of medical devices

B) Advancing safe and effective medical devices

C) Eliminating the need for clinical trials

D) Increasing competition among medical device manufacturers

3. Under the EU Medical Device Regulation (MDR), what additional step may some manufacturers need to take due to device reclassification?

A) Register their devices in the United States first

B) Undergo additional conformity assessments

C) Eliminate post-market surveillance

D) Apply for a separate CE mark for each EU country

Recap & CTA

Just a quick recap! Earlier this month, the FDA approved Amgen’s combination therapy for metastatic colorectal cancer and highlighted advances in medical device safety in its most recent report. Meanwhile, the EU’s MDR enforces strict rules on clinical evaluation and transparency for CE marking compliance.

Now, a CTA, or a Call to Action, is a prompt designed to inspire or guide someone to take a specific action. In a sense, it’s a way to encourage engagement or motivate progress. This time, my CTA for you is as follows.

I challenge you to take a moment to pause and reflect. Whether it’s five minutes or an entire day, take time to acknowledge your own growth. Celebrate what you’ve achieved and let it fuel your next steps. Then, head to the comments and share one thing you’re determined to accomplish this year! For me, it’s organising LIVE events on LinkedIn. What’s your top work- or study-related New Year’s resolution? Drop it below in the comments.

Until next time!