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The Center for Devices and Radiological Health (CDRH) is encouraging research on the use of digital health technologies (DHT) to advance patient engagement, leverage connectivity and improve healthcare, according to a report the center released last week. Read More
Representatives from Medtronic and Masimo, both manufacturers of pulse oximeters for more than three decades, defended the accuracy of their devices for patients of all skin tones at an FDA advisory panel meeting yesterday. Read More
The total time to get an FDA decision on a 510(k) application submitted through a third-party reviewer improved from 2018 to 2022, the FDA reported, but still missed the agency’s goal of a decision in 108 days. Read More
Senior FDA officials at last week’s MedTech Conference in Boston wove the theme of engagement with submitters into a wide array of answers to questions about more rapid development of devices. Read More
EndoStim has received the FDA’s Breakthrough Device designation for its EndoStim System for treatment of patients with gastroesophageal reflux disease (GERD) who do not respond to drug therapy. Read More
The FDA’s General and Plastic Surgery Devices Panel met on Wednesday and Thursday to consider the agency’s proposed classifications of seven types of devices, voting in all cases to support its recommendations. Read More
The FDA aims to help industry prepare responses to deficiency letters by suggesting a standardized format, the agency said in a final guidance released yesterday. Read More