Distilled water is easy to make at home once you know how to do it.
Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...
Medicare covers continuous positive airway pressure (CPAP) machines when a doctor orders them for individuals with sleep apnea and who meet other Medicare requirements. If a doctor confirms the ...
Litigation between companies in the med-tech space often revolves around patents, but the ongoing series of lawsuits between Philips Respironics Inc. and Soclean Inc. are directed toward the ...
WASHINGTON – Four companies have received warning letters from the U.S. Food and Drug Administration for selling CPAP cleaning products without marketing clearance or approval, violating the Federal ...
The U.S. FDA caught up with four makers of CPAP cleaning machines in the form of warning letters advising the manufacturers that the claims made for their systems fall under the definition of a ...
Please provide your email address to receive an email when new articles are posted on . The FDA has granted de novo clearance to SoClean 3+, an over-the-counter bacterial reduction device for certain ...
SILVER SPRING, Md., Feb. 27, 2020 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is issuing a Safety Communication to inform patients and health care providers that devices claiming to ...
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