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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
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