Medical Device News Update - September 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, 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.

Quick Summary

New device approvals/clearances

1. A hearing aid feature mobile app from Apple (De Novo DEN230081).
2. A leaflet splitting device to treat patients at risk of coronary obstruction undergoing valve-in-valve TAVR (De Novo DEN240017).
3. An externally applied cooling device for temporary pain relief to the eye in an ophthalmic procedure (De Novo DEN230011).
4. A silicone gel-filled breast implant for primary breast augmentation or revision augmentation PMA (PMA, Original, P230005).
5. A total of 230 devices were cleared through the 510(k) pathway during September 2024. Days to FDA decision ranged from 7 to 1281 days with a median of 138 days. Top 5 medical specialties were Orthopedic (OR), Radiology (RA), General & Plastic Surgery (SU), Cardiovascular (CV), and Dental (DE) accounting for 62% (142/230) of devices cleared.

Featured Innovation: Apple Hearing Aid Feature (HAF)

Imagine if you could use your Apple Airpods Pro as a hearing aid?

Well, now you can. Recently, Apple received FDA authorization for a Hearing Aid Feature (HAF), which provides hearing assistance through the Airpods Pro following a self-administered hearing test.

The hearing aid market is worth billions of dollars in the US, and growing rapidly. Still, only 20% of those who could benefit from a hearing aid seek any intervention, resulting in a rapid deterioration of their condition over time.

According to the CDC, 13% of US adults aged over 18 experience difficulty hearing even when using a hearing aid. Hearing difficulties increase as we get older. In the United States, 26.8% of adults 65 and older experience some difficulty and 4.1% have a lot of difficulty or cannot not hear at all.

These numbers translate to millions of people in the US and across the world. When we cannot hear well, we are not able to communicate or participate in life-enriching activities. It gets worse as we age, and in some cases, hearing difficulties can accelerate cognitive and functional decline.

The US FDA recently created a new category of over-the-counter (OTC) hearing adults 18 or older with perceived mild to moderate hearing loss. This is a promising development, which lowers barriers to access and facilitates new innovations.

Learn more about how Apple deployed a smart strategy to demonstrate benefit-risk of this Software as a Medical Device (SaMD).

Warning Letters

There were no warning letters issued to medical device manufacturers during September 2024.

Class I Recall Announcements

1. Baxter Healthcare: disconnection risk for certain components used in a ventilator system.
2. Medtronic: risk of battery instability and overheating in MAC video laryngoscopes.
3. Breas Medical: risk of short-term formaldehyde exposure from emissions in Vivo 45 LS ventilators.
4. Abbott Diabetes Care: risk of inaccurate glucose readings from a small number of FreeStyle Libre 3 sensors.
5. Fresenius Kabi USA: risk of medication overdose due to a manufacturing defect in the administration set used in an infusion system.
6. B. Braun Medical, Inc.: risk of pump stopping in an infusion system due to false occlusion alarms.
7. Smiths Medical: risk of tracheostomy displacement or decannulation due to a manufacturing defect.
8. Smiths Medical: risk of loosening or disconnection of the patient outlet connector in certain emergency and transport ventilators.
9. Baxter Healthcare: contamination risk due to particulate matter in primary packaging of some components used in a pharmacy compounding device.
10. Smiths Medical: risk of inadvertent movement of the tidal volume knob in certain emergency and transport ventilators.

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

References

1. Apple Hearing Aid Feature: De Novo Decision Summary , Issued December 2023.
2. Let's Talk Risk! newsletter

=====================================================

👍Like this article? Click here to unlock exclusive subscriber-only content.