All Posts

Cybersecurity due diligence should not end when an acquisition closes. In July 2026, Abbott disclosed unauthorized access to a limited number of internal systems within its Cancer Diagnostics business, which was formed following its acquisition of Exact Sciences. Abbott stated that the incident did not affect products, manufacturing, laboratory operations, business operations, or its ability to serve patients. It also noted that legacy Exact Sciences systems remained separate

Digital health companies often face a deceptively simple question early in development: Is this software a medical device? The answer can dramatically affect product strategy, development timelines, quality system expectations, validation planning, labeling, and commercialization. A product that appears to be a consumer wellness app or clinical workflow tool may still fall under FDA oversight depending on its intended use, claims, functionality, outputs, and user population.

Recent reports highlighted a major cyber incident that disrupted systems at Stryker, affecting operations across parts of its business. While details are still evolving, the situation offers a clear reminder of how deeply interconnected modern medical technology has become. This is no longer just an IT issue. It is an operational, clinical, and patient safety concern. What Happened and What Followed The attack led to widespread system outages, impacting internal operations an

February 2026 The FDA issued an early alert last week about Trividia Health's TRUE METRIX blood glucose monitoring systems. All models are subject to a labeling correction affecting devices distributed across the United States, UK, Mexico, Australia, and the Caribbean. The issue? An error code that means two completely different things, and instructions that didn't make the life-threatening scenario clear enough. Since the product launched in August 2014, there have been 114

The Misconception We Need to Address There's a persistent narrative in Western medtech circles that Chinese medical devices succeed primarily due to easier regulatory pathways, government favoritism, or well-connected networks rather than genuine innovation. Sure, regulatory landscapes differ across markets, and relationship-building plays a role in business success everywhere (including the United States). But this view severely underestimates what's actually happening on th