Medical Device News Update - January 2025

FDA approvals, warning letters and Class I recalls issued during January 2025

Monthly roundup of FDA approvals, warning letters and recalls issued in January 2025

Each month, Let’s Talk Risk! (LTR) provides a comprehensive summary of new device approvals or clearances, warning letters, and Class I recall announcements issued by the FDA in the previous month.

As a risk practitioner, it is very important to stay up to date with the latest regulatory developments affecting the medical device industry. A review of latest innovations approved or cleared by the FDA helps in understanding different ways the agency evaluates benefit-risk of medical devices when reviewing their safety and effectiveness. Warning letters and recall announcements are useful in building awareness of gaps in quality management system and the risk management process that should be addressed before they are cited by the FDA.

Only publicly available information is curated in this article. Links to relevant sources are provided in the footnotes.

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Quick Summary

New device approvals/clearances

1. A device to objectively measure muscular fatigue for training athletes (De Novo DEN230051).

2. A bone growth stimulator device for treatment of non-unions and accelerated healing of fractures (PMA, Original, P210016).

3. A device to assess kidney function by transdermal measurement of the Glomercular Filtration Rate (GFR) (PMA, Original, P230019).

4. A total of 255 devices were cleared through the 510(k) pathway during January 2025. Days to FDA decision ranged from 1 to 634 days with a median of 127days. Top 5 medical specialties were Radiology (RA), Orthopedic (OR), Cardiovascular (CV), General & Plastic Surgery (SU), and GI/Urology, accounting for 55% (141/255) of devices cleared.

FDA warning letters

There were no warning letters to medical device manufacturers in January 2025.

Class I recall announcements and early alerts

1. Getinge and Maquet: risk of injury due to bent or detached heater wire and silicone peeling from an endoscopic vessel harvesting system (Correction)

2. Fresenius Kabi USA: risk of injury due to software issues in the infusion pump system (Early Alert).

3. Nova Biomedical: risk of incorrect result from a glucose meter due to software issues (Correction).

4. Fresenius Kabi USA: risk of infusion pump failure due to pneumatic valve issue (Recall).

5. Trokamed GmbH: risk of misuse due to missing warnings and precautions in the IFU for nephroscope sheath (Correction).

6. Olympus: risk of exposure contaminated endoscope accessory (Recall).

7. Nuwellis: risk of termination of blood filtration therapy due to too many alarms (Recall).

8. Medline: incorrect assembly of fluid delivery set in a convenience kit (Recall).

9. Mercury Medical: risk of ineffective ventilation due to spring issue in the emergency resuscitator (Recall).

Let us take a closer look.