A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in ...

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking ...

In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market ...

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a ...

One newer security concern involves implanted medical devices and vulnerabilities to hackers. As it stands, about 10–15 devices are connected across the nation. Most of these are vulnerable to hackers ...

Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use. EU MDR required companies to make significant ...

When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more ...

Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of ...

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s ...

Quality culture is a cornerstone of any industry, particularly the healthcare industry where patient lives are at stake. The implications of quality culture extend beyond operational efficiency; they ...

A recent project conducted by Northeastern graduate students looked at device recalls over the past five years and some of the common threads. In 2018, the top causes of recalls were software, ...