Medical device companies are racing to integrate artificial intelligence (AI) into their products, promising revolutionary improvements in healthcare. However, safety concerns are mounting as regulators report a growing number of patient injuries linked to AI-enhanced devices.
In 2021, Acclarent, a unit of Johnson & Johnson, incorporated AI into its TruDi Navigation System, which is used in sinus surgeries. Before the integration of AI, the U.S. Food and Drug Administration (FDA) had received seven reports of malfunctions and one patient injury.
Since the upgrade, over 100 malfunctions and adverse events have been reported, with at least ten patients reportedly injured, including cases of strokes and cerebrospinal fluid leaks. Lawsuits filed in Texas allege AI contributed to these injuries, although Integra LifeSciences, which acquired Acclarent, denies any causal link.
The FDA now oversees over 1,357 AI-enabled medical devices, including heart monitors and ultrasound systems. Research shows AI devices have a higher recall rate than conventional devices, with 43% of recalls occurring within a year of approval. Experts say the agency is struggling to handle the surge, especially after staff reductions under the Trump administration and ongoing budget pressures.
While AI has the potential to improve diagnostics, surgical accuracy, and patient outcomes, critics warn that current FDA regulatory practices may be insufficient to ensure safety, as many devices are cleared without clinical testing on patients.
Source: Reuters
