What a doozy of a year 2021 was in the medical device space – capped on one end by a deadly insurrection blasted by medtech heavy-hitters, and on the other end by news that the COVID-19 Omicron variant is wreaking havoc on some diagnostics (and many US FDA on-site inspections). Here are Medtech Insight’s Top 21 US regulation, policy, quality control and compliance stories of 2021, as determined by reader interest.

Royal Philips says a first round of testing on its first generation DreamStation has found that the level of volatile organic compounds (VOCs) put off by the recalled device “is not typically anticipated to result in long-term health consequences for patients.”

Experts foresee the digital therapeutics market growing to $6bn-$9bn by 2025, driven in part by tech-empowered consumers and patients looking for solutions to better manage their own health and conditions. For medtechs, collaborations with software-driven start-ups will be key to harnessing personalized data and differentiating themselves in the marketplace.

Experts foresee the digital therapeutics market growing to $6bn-$9bn by 2025, driven in part by tech-empowered consumers and patients looking for solutions to better manage their own health and conditions. For medtechs, collaborations with software-driven start-ups will be key to harnessing personalized data and differentiating themselves in the marketplace.