Device manufacturers looking to bolster the biocompatibility of their products can now turn to Healionics, a supplier of biomaterial scaffolds designed to improve the biointegration of percutaneous or fully implanted medical devices. The company's STAR technology is a synthetic, three-dimensional matrix, similar to a thin, porous sponge. Because this biomaterial has been precisely engineered with uniform pore sizes to the approximate size of a single cell, the company says that living tissue and new blood vessels actually grow and weave into these pores.
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An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
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.
