There are four pillars of chronic wound care, and few products address all of them satisfactorily. The four factors encouraging wound healing include debridement, bacterial management, increased blood circulation, and the stimulation of healthy cells. Celleration believes it has all four requirements covered with its MIST Therapy System ultrasound device for wound healing.
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Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.
The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.