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Food and Drug Administration (FDA)

Johnson & Johnson Medical Devices Companies has announced that Ethicon has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VistaSeal open and laparoscopic Dual Applicators (35 cm and 45 cm), for surgical bleeding. Read more

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Turbex is promoting its highly controllable, standard and bespoke cleaning equipment for washing and drying medical instruments, prosthetics and consumables after manufacture. Read more

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Boston Scientific has entered into a definitive agreement to acquire Vertiflex, a privately-held company which has developed and commercialised the Superion Indirect Decompression System. Read more

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The Food and Drug Administration has approved Boston Scientific’s Vici Venous Stent System for the treatment of iliofemoral venous obstructive disease. Read more

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CSA Medical has announced its RejuvenAir System has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA). Read more

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Drug delivery systems provider Aptar Pharma has announced that its Bidose nasal spray device was recently approved by the U.S. FDA for a breakthrough therapy in the field of depression. Read more

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BD has responded to warnings from the FDA surrounding risks from drug-coated devices by trying to reassure customers and shareholders. Read more

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The Food and Drug Administration commissioner Scott Gottlieb has tendered his resignation, meaning he will leave his post next month. Read more

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The Food and Drug Administration (FDA) has revealed it has received an increase in reports of breast implants linked to a deadly cancer. Read more

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The Advanced Medical Technology Association (AdvaMed) has proposed legislation to continue medical device reviews from the Food and Drug Administration (FDA) in the event of U.S. government shutdowns. Read more

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Medtech company Becton, Dickson and Company (BD) has seen its second generation BD Nano pen needles given 510(k) clearance by the U.S. Food and Drug Administration. Read more

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Boston Scientific Corporation has launched the Vercise Primary Cell (PC) and Vercise Gevia Deep Brain Stimulation (DBS) Systems featuring the Vercise Cartesia Directional Lead. Read more

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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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