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Science Designer Science Designer

510(k) Clearance — Byonyks X-1 APD Cycler: Making Dialysis Safer and More Accessible

We are thrilled to share some exciting news from one of our partners, Byonyks – their latest medical device, the Byonyks X-1 Automated Peritoneal Dialysis (APD) Cycler, has received 510(k) clearance from the FDA! This achievement marks a significant step forward in expanding access to life-saving dialysis treatment, and we are proud to have played a role in this journey.

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Science Designer Science Designer

Recap of the 2025 Combination Products Summit

The energy was infectious at this year's Combination Products Summit hosted by PharmaED Resources Inc., where industry and vendor attendees came together in the Philadelphia Historic District to discuss regulatory guidance insights, risk management considerations, and new product and technology innovations…

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Science Designer Science Designer

HFES Health Care Symposium 2025: Pushing Boundaries and Questioning Traditions

The 2025 International Symposium on Ergonomics and Human Factors in Health Care was marked by a spirit of pushing boundaries. Perhaps due to the rare out-of-US location, various human factors (HF) “traditions” were questioned by presenters and attendees – most notably, requirements and expectations around 1) user groups and sample sizes, 2) platform device testing, and 3) knowledge task methods.

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