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FDA faces federal probe over medical device oversight

FDA faces federal probe over medical device oversight
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Ketryx Rakes In $14M to Speed Up Medical Device Development & Quality Assurance

Ketryx raised $14 million in Series A funds. The startups sells a platform designed around FDA regulations and quality standards that automates much of the work required from medical device companies’ development and quality teams.

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It s Time to Make Effective Alternatives a Bigger Part of the CPAP Recall Story

For those unfamiliar with the CPAP recall situation in question, imagine if one-third of all cars on the road were suddenly recalled for potentially life-threatening issues. Now imagine that in the aforementioned hypothetical automobile recall, the media dedicated its energy almost entirely to reporting on the worsening problem without making viewers aware of potential solutions.

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Understanding The Root Causes Of Medical Device Recalls

In terms of metrics, medical companies should not have a goal reducing recalls, this will lead to behavior that could put users at risk by leaving bad products on the market, the goal should be to reduce the underlying quality problems that might trigger the need for recall.

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Medtronic hit with FDA warning letter for diabetes devices

The company received a warning letter on Wednesday related to inadequate quality requirements at the headquarters for its diabetes business. It comes after Medtronic expanded a recall of its MiniMed 600 series insulin pumps.

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