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Within days of the reauthorization by Congress of the FDA’s user fee programs for the next five years, the agency posted its fiscal 2023 device user fees – increasing most of them by a hefty 18 percent and a couple by more than 50 percent. Read More
The FDA offers advice on postmarket surveillance and postapproval studies for moderate and high-risk devices in two final guidance documents released yesterday. Read More
Pfizer has completed its acquisition of Australian diagnostic software developer ResApp Health for $115 million, expanding its reach into digital health products. Read More
Natera’s Signatera circulating tumor DNA (ctDNA) test outperformed the cancer antigen CA 125 test by one month and radiological imaging by 10 months in identifying patients with the highest risk of recurrence of epithelial ovarian cancer (EOC), researchers reported in the journal Gynecologic Oncology. Read More
Flawless Beauty and Skin is importing and marketing unapproved devices, according to a warning letter the FDA sent the Ocean, N.J., firm following an inspection at that facility Nov. 16, 2021, through Jan. 19, 2022. Read More
Most machine learning-enabled medical devices are cleared by the FDA without efficacy demonstrated in a randomized clinical trial, researchers at the Harvard-MIT Health Sciences and Technology program reported in the journal JAMA Network Open. Read More
All the moving parts involved with the EU Medical Device Regulation (MDR) mean that devicemakers must have a carefully targeted strategy for compliance with the regulation. Read More