Medical Device News Update - May 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 to study for 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. An AI/ML enabled device for home use by patients with neovascular age-related macular degeneration for review by their ophthalmologist (De Novo DEN230043).
2. A smart phone app for remote monitoring of orthodontic treatments and treatment progress (De Novo DEN230035).
3. A digital sensor and monitoring system for physical/chemical sterilization processes (De Novo DEN230068).
4. A breakthrough device for qualitative detection of colorectal neoplasia associated with RNA markers and for the presence of occult hemoglobin in human stool. (PMA, Original, P230001).
5. A total of 279 devices were cleared through the 510(k) process during May 2024. Days to FDA decision ranged from 7 to 872 days with a median of 167 days. Top 5 medical specialties were General & Plastic Surgery (SU), Orthopedic (OR), Radiology (RA), Cardiovascular (CV), and Dental (DE) accounting for 59% (165/279) of devices cleared.

Featured Innovation: ColoSense(R) colorectal cancer screening test

ColoSense(R) is an RNA-baaed colorectal cancer (CRC) screening test using stool samples.

It is indicated for qualitative detection of colorectal neoplasia associated with RNA markers and for the presence of occult hemoglobin in human stool.

This device was granted the Breakthrough device status on January 10, 2020 by FDA. A first of a kind non-invasive test, it uses RNA biomarkers instead of DNA.

According to the company website:

In average-risk individuals, ColoSense successfully demonstrated 93% sensitivity for CRC and importantly identified 100% of CRC in Stage I, when the disease is most curable. Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable. Notably, the study reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49, a critically important screening demographic.

These results are significantly better than the fecal immunochemical test (FIT), one of the currently used non-invasive test for colorectal cancer screening.

Based on the safety and effectiveness data, FDA approved the PMA in May 2024 with a post-approval study requirement.

Warning letters

FDA issued 1 warning letter in May 2024:

1. Cue Health, Inc.: Marketing of COVID-19 tests with unauthorized changes, shipping product with inadequate quality control.

Class I recall announcements

There were a total of 7 Class I announcements in May 2024:

1. Tandem Diabetes Care, Inc.: Version 2.7 of iOS t:connect mobile app due to software error leading to pump battery depletion.
2. Route 92 Medical Inc.: medical delivery catheters due to distal tip separation.
3. Philips Respironics, Inc..: Trilogy Evo ventilators due to software related power malfunction.
4. Abbott: Heartmate 3 LVAS implant kit for risk of blood leakage or air entry between inflow cannula and apical cuff.
5. Hologic, Inc.: BioZorb markers due to complications with implanted devices.
6. Vyaire Medical, Inc.: Twin tubes due to the potential of nozzle separating during use on a patient undergoing a stress test.
7. OptumHealth Care Solutions.: Nimbus II infusion pumps related to another recall due to multiple potential failure modes.

For links to each of these updates, click the link below to access the full article.

Let me know in your comments below?? if you find this information useful.

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