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Latest From Royal Philips
The operating environment for medical technology companies becomes more complex, competitive and costly every year. There is no expectation that 2022 will buck that trend, even as the medtech sector prepares for a third year of working under conditions shaped by the COVID-19 pandemic.
Industry experts weigh in on what the US FDA’s enforcement options are following the company’s high-profile recall of millions of breathing devices and unfavorable facility inspection results.
Damning FDA-483: Philips Didn’t Investigate 222,000 Complaints Of Possible Degraded Foam In Breathing Devices
Royal Philips has been reeling from a June recall of millions of breathing machines, and now it’s been slapped by the US FDA with multiple observations after an on-site inspection. One observation says the company didn’t open formal investigations after receiving hundreds of thousands of complaints of particles and other contaminants when the recalled devices were used.
Apnimed is going to conduct one more Phase II study in sleep apnea, mainly to assess subjective endpoint questionnaires, and then hopes to launch a Phase III program by autumn of 2022.