Medical Device News Update - July 2023

FDA approvals, warning letters and recalls issued during the month of July 2023

Monthly roundup of FDA approvals, warning letters and recalls issued in July 2023

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 the benefit-risk of devices when reviewing their safety and effectiveness. Warning letters and recall announcements are useful to study to build awareness of gaps in quality management system and the risk management processes 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 referenced in the footnotes.

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Quick Summary

1. New device approvals/clearances

   1. A digital therapeutic device to help diabetes patients set goals, track progress and connect behavioral changes to improvement in biometrics (De Novo)

   2. A Bluetooth enabled device to monitor and guide the axial and sagittal trajectory for precise placement of pedicle screws (De Novo)

   3. A surgical assist device used for precise and stable positioning of an instrument while maintaining direct surgeon control robotic-assisted ENT surgery (De Novo)

   4. Minitouch 3.8 Era thermal endometrial ablation system (PMA, P230002)

   5. CraniSeal dural sealant (PMA, P220014)

   6. Palmaz Mullins XD pulmonary stent (PMA, P220004)

   7. A total of 254 devices were cleared through the 510(k) process during July 2023. Days to clearance ranged from 1 to 854 with a median of 127 days. Top 5 medical specialties were Orthopedic, Radiology, General & Plastic Surgery (SU), Cardiovascular (CV) and Dental (DE), accounting for 59% (151/254) of devices cleared.

2. FDA warning letters

   1. FDA did not issue any medical device related warning letters during July 2023.

3. Class I recall announcements

   1. There were a total of 9 Class I announcements on the FDA’s website

      1. Megadyne: MEGA 2000 and MEGA SOFT reusable patient return electrodes for risk of serious burn injuries

      2. Draeger Medical: Oxylog 3000 Plus emergency and transport ventilators for risk of unexpected battery depletion and ventilator stop

      3. NOxBOx Ltd: NOxBOXi nitric oxide system for manifold failure that may cause gas leaks and interruption of therapy to neonates

      4. Quidel Cardiovascular Inc.: Quidel Triage Cardiac Panel for risk of false negative troponin levels that could delay diagnosis and treatment of missed heart attack

      5. Medtronic: ICDs and CRT-Ds defibrillators with glassed feedback for risk of low or no energy output during high voltage therapy

      6. Abbott: Amplatzer steerable delivery sheath for increased risk of air embolism

      7. Abiomed: Impella left-sided blood pumps for risk of motor damage after contact with transcatheter aortic valve replacement (TAVR) stent

      8. GE Healthcare: TruSignal SpO2 sensors for issues that may reduce defibrillation energy, expose patients to unintended voltage or give inaccurate readings

      9. Baxter Healthcare: SIGMA Spectrum infusion pump and infusion system for repeat upstream occlusion false alarms that may delay or interrupt delivery of life-sustaining therapy

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