Tekcapital PLC- Oxford-based intellectual property investor - Investee Belluscura PLC has experienced Covid-19 related supply chain disruption which has increased the scarcity of certain key components, increased lead times, and reduced capacity at part manufacturers and testing facilities. However, the medical device maker is "making good progress" in its 510K submission. Belluscura currently in the process of completing the final surety tests and expects to receive clearance in the second half to the end of November. A 510K is a submission made to the Food & Drug Administration to demonstrate that a device to be marketed is safe and effective.
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By Ife Taiwo; ifetaiwo@alliancenews.com
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