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The Latest in Life Science
The Direct-to-Consumer Revolution in Digital Healthcare: Regulatory and Operational Challenges
At my last doctor’s appointment, I learned how to use my smartwatch to perform an electrocardiogram (ECG) to test for atrial fibrillation. Naturally, I found myself checking my ECG multiple times a day, curious about the fluctuations in my heart rate. Did I have cause for concern? Fortunately, my watch consistently reported no evidence of atrial fibrillation, while also issuing a clear disclaimer that it could not detect signs of a heart attack.
Digital Twins in Medicine: Science Fiction or Modern Data Miracle?
The term “digital twin” may evoke images straight from the pages of science fiction, such as Nobel Prize winner Kazuo Ishiguro’s dystopian novel, Never Let Me Go, in which biological clones are raised solely for their organs. In reality, the concept of a digital twin in medicine—while still emerging—is no longer confined to fiction.
Ethylene Oxide & Medical Device Sterilization: A Litigation Overview
Last year, Berkley Life Sciences’ Blog featured an important post on Preventing Medical Device Shortages Through Improving the United States Sterilization Supply Chain. That article highlighted potential supply chain constraints caused in-part by sterilization facility shutdowns and regulatory requirements to install or upgrade emission control equipment. What that post did not address—and what this article will explore—is the nationwide litigation that has impacted the sterile medical device industry over the past five years.