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Food and Drug Administration (FDA)

Sensor technology company Bruin Biometrics (BBI) has seen its SEM Scanner granted marketing authorisation from the Food and Drug Administration (FDA). Read more

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The Food and Drug Administration (FDA) has approved Medtronic’s InterStimsmart programmer for use with the InsterStim system which provides treatment for an overactive bladder, chronic faecal incontinence and non-obstructive urinary retention. Read more

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The Food and Drug Administration has announced it is finalising guidance on its existing Breakthrough Devices Program as well as announcing plans for a Safer Technologies Program (STeP). Read more

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Eight medical device firms have been selected by the Food and Drug Administration (FDA) to help prevent and treat opioid use disorder. Read more

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The Food and Drug Administration (FDA) has granted Breakthrough Device Designation to artificial intelligence software for chronic thromboembolic pulmonary hypertension (CTEPH) pattern recognition. Read more

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The Food and Drug Administration (FDA) has announced “several key actions” to update its Medical Device Safety Action Plan with the aim of creating a more robust medical device safety net through better data. Read more

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The U.S. Department of Health and Human Services has found that the Food and Drug Administration’s (FDA) plans and processes were deficient for addressing medical device cybersecurity compromises. Read more

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A UK-based medtech company has been given regulatory clearance from the U.S. Food and Drug Administration (FDA) for its Avelle Negative Pressure Wound Therapy (NPWT) system. Read more

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