Medical Device News Update - August 2024

Note: This article is a summary of the original article published in my Let's Talk Risk! newsletter on Substack, a reader-supported publication. Read the full article here.

Each month, I compile a comprehensive list of medical device news from the prior month, focusing on FDA approvals, warning letters and recalls.

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 for building awareness of gaps in quality management system and the risk management process that should be addressed before they are cited by the FDA.

Quick Summary

New device approvals/clearances

1. A high throughput genetic sequencing based tumor profiling test (De Novo DEN230046).
2. A device to reduce bacterial load on respiratory devices and accessories (De Novo DEN210037).
3. A home-based test for qualitative detection of syphilis (De Novo DEN230090).
4. A rapid UV disinfection chamber for ultrasound probes (De Novo DEN230067).
5. An implantable nerve stimulation device to reduce post-amputation pain, breakthrough device designation (PMA, Original, P230020).
6. A stent system for treatment of pulmonary artery stenosis, breakthrough device designation (PMA, Original, P240003).
7. A companion diagnostic assay for qualitative detection of 517 genetic variants in tumor tissues from patients considered for VITRAKVI® and RETEVMO® therapies (PMA, Original, P230011).
8. A companion diagnostic assay for detection of MAGE-A4 protein as an aid in identifying patients considered for TECELRA® immunotherapy (PMA, Original, P230016).
9. A total of 283 devices were cleared through the 510(k) pathway during August 2024. Days to FDA decision ranged from 1 to 1062 days with a median of 116 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), General & Plastic Surgery (SU), Cardiovascular (CV), and Dental (DE) accounting for 62% (176/283) of devices cleared.

Featured Innovation: Minima Stent System from Renata Medical

The Minima Stent system received the breakthrough device designation from the FDA on February 7, 2022. It is indicated for use in the treatment of native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children at least 1.5 kg in weight.

The Minima stent system includes the following components:

1. The Minima stent
2. The Minima delivery system: balloon catheter, outer covering catheter

According to the Summary of Safety and Effectiveness Data (SSED):

As evidenced by the results of the GROWTH study, the performance goal of the primary endpoint was met, with 41 out of the 42 subjects (97.2%) meeting the criteria for clinical success at the 6-month follow-up visit.

Further:

The results from the non-clinical laboratory and animal testing demonstrate that the device is suitable for long-term implant. The safety assessment for the GROWTH Trial was based on freedom from procedure- or device-related serious adverse events.

Based on these results, FDA approved the PMA on August 28, 2024, with continued follow-up and a new post-approval study.

Warning letters

1. Shenzhen Moyeah Intelligent Life Technology Co.: Marketing of various CPAP cleaning products and accessories without FDA authorization.
2. Adventure Innovations LLC: Marketing of UV based cleaning/disinfecting devices for CPAP and accessories without FDA authorization.
3. Natures Pillows, Inc. and Top Dog Direct, LLC: Marketing of sanitizers for CPAP and accessories without FDA authorization.
4. LEEL Tech: Marketing of sanitizers for CPAP and accessories without FDA authorization.

Class I recall announcements

1. Smiths Medical: multiple issues with older versions of the software in the CADD-Solis and CADD-Solis VIP Ambulatory infusion pumps.
2. Medtronic: correction for NIM Vital Nerve Monitoring System due to the potential for false negative response.
3. Abiomed: removal of 9 Impella CP with SmartAssist Systems due to release of products that failed QC inspection.
4. ICU Medical: diminished battery life due to manufacturing error which can impact infusion pump operation.
5. Defibtech, LLC: motor failure in a chest compression device.
6. Medline Industries, LP: defective syringes in convenience kits that may break or leak.
7. Inari Medical: patient injuries and deaths due to entrapment of a clot removing catheter.

For links to each of these updates, click the link below to access subscriber-only content:

References

1. Renata Medical: Minima Stent System, Website accessed on 17 Oct 2024.
2. Let's Talk Risk! newsletter

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