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"We are excited to partner with Aptar Pharma to develop a product that can provide patients with a life-saving treatment,” said Bryn Pharma CEO David Dworaczyk. Read More
The company kept complaints and customer feedback in a bound notebook that displayed part of its complaint regulation in a piece of paper taped to the front. Read More
The Aquilion Precision uses deep learning neural networks “specifically trained to perform one task — reconstruct images that are sharp, clear, and distinct,” the company said. Read More
The company claims the coil is “a game-changing product” that may offer significant advantages in neurovascular and peripheral vasculature applications. Read More
J&J is required to fully disclose the devices’ risks and place accurate information on promotional material and the “information for use” section of package inserts. Read More
In addition, written procedures for medical device reporting and CAPA handling were not established, and the firm was written up again for lacking complaint handling procedures Read More