by Allen Curreri | Jan 13, 2025 | Diagnostic Aids, Health, Medical Technology
The medical device industry is a rapidly evolving sector where innovation meets rigorous regulatory oversight. Companies aiming to introduce devices to the European and U.S. markets must navigate two distinct regulatory landscapes: the European Union’s Medical Device...
by Allen Curreri | Dec 6, 2024 | Diagnostic Aids, Health, Medical Technology
Medical devices have revolutionized the healthcare industry, bridging the gap between innovation and patient care. From diagnostic tools to life-saving equipment, these devices play a crucial role in improving patient outcomes, enhancing efficiency, and pushing the...
by Allen Curreri | Nov 8, 2024 | Diagnostic Aids, Health, Medical Technology
The medical device industry operates under rigorous regulations in Europe and the United States to ensure that devices are safe, effective, and trustworthy. Despite their shared goals, the regulatory landscapes in Europe and the U.S. differ significantly, each with...
by Allen Curreri | Oct 1, 2024 | Diagnostic Aids, Health, Medical Technology
Wearable medical devices are transforming healthcare by providing real-time monitoring, diagnosis, and even treatment for various health conditions. From smartwatches that track heart rates to continuous glucose monitors for people with diabetes, these devices promise...
by Allen Curreri | Aug 5, 2024 | Diagnostic Aids, Health, Medical Technology
The European Union (EU) is leading in regulating artificial intelligence (AI), particularly in the sensitive field of medical devices. With the rapid advancement of AI technology, concerns about patient safety, data privacy, and ethical implications have grown. The EU...