pharmaphorum

JUNE 18, 2021

Teasing out complex relationships within data lies at the heart of any digital health intervention, but finding the algorithms to do so reliably – and making sure they will be acceptable to regulators – can be a challenge. The algorithms used in healthcare are becoming more complex as well. The next steps?

Production 98

Production Regulation Manufacturing Packaging 98

FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

Clinical Trials 59

Clinical Trials Clinical Trials Insulin Radiology 59

XTalks

JUNE 12, 2023

Internationally, Medtronic expanded its MiniMed 780G insulin pump and Guardian 4 sensor. Siemens Healthineers further demonstrated its commitment to innovation at the European Congress of Radiology in Vienna, showcasing its revamped Acuson ultrasound portfolio. It also plans to launch these products in the US.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98