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The average total review time declined from 170 calendar days in 2018 to 126 in 2022, but there was a pandemic-related spike to 190 days in 2020. Read More
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
Johnson & Johnson (J&J) announced Tuesday that it would acquire Massachusetts-based Abiomed, gaining access to the medical device company’s Impella heart pump, which treats conditions such as heart attack, heart failure and clogged arteries. J&J will pay $380 per share upfront in cash, which equates to a value of approximately $16.6 billion. 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
The FDA issued a Form 483 to RetroFix Screws for inadequate design controls and other deficiencies observed during an inspection of the company’s facility in Salisbury, N.C. Read More
The top clinical areas to receive the breakthrough designation have been cardiovascular, neurology, orthopedic, gastroenterology and urology. Read More