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Food and Drug Administration (FDA)

Kevin Grygiel, Prisym ID, examines the past years’ labelling compliance challenges surrounding UDI implementation more

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The US Food and Drug Administration (FDA) is approving medical devices before studies on their safety or effectiveness have been released to the public, Reuters Health reported more

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The first buprenorphine implant that helps treat people who have opioid dependency has been approved by the US Food and Drug Administration (FDA) more

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Strailite, a medical device that treats stretch marks, has recently been cleared by the Food and Drug Administration (FDA) for home use more

Devices

The US Food and Drug Administration (FDA) have issued draft guidance for 3D printed medical devices more

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The FDA has unveiled draft guidance for secure data exchange in medical devices more

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A bill approved by a Senate committee will speed up medical device approvals by the US Food and Drug Administration (FDA) and increase funding for medical research more

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The US Food and Drug Administration (FDA) Advisory Committee gives Abbott’s fully dissolving heart stent a positive review and recommends the FDA approve it more

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A robotic exoskeleton, which enables individuals with spinal cord injury to stand and walk, has been given US Food and Drug Administration (FDA) clearance for clinical and personal use more

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The US Food and Drug Administration (FDA) has approved hip replacement implants that use ceramic made by CoorsTek Medical more

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Avinger’s medical device, which allows doctors see inside arteries and remove dangerous plaque, has been given US Food and Drug Administration (FDA) approval more

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Image: FDA

Cook Medical has expanded the recall for its beacon tip Angiographic Catheters more

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Bedfont Scientific has been added to the US Food and Drug Administration’s (FDA’s) quality system import alert list for medical device companies more

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Medtronic has announced US Food and Drug Administration (FDA) 510(k) clearance and launch of the OsteoCool RF Ablation System more

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Polyganics has received FDA 510(k) clearance for Neurocap, a device designed to reduce neuroma formation and facilitate tissue repair and regeneration more

Technology

The US Food and Drug Administration (FDA) has issued draft guidelines on how medical device makers can protect patients from cybersecurity vulnerabilities in their devices more

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The Psychopharmacologic Drugs Advisory Committee (PDAC) of the US Food and Drug Administration (FDA) has voted in favour of approving Probuphine, an implant to treat opioid addiction more

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The Food and Drug Administration (FDA) has approved a matrix device made from silicone, cow collagen and shark cartilage to treat certain diabetic foot ulcers more

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Medtronic has announced US Food and Drug Administration (FDA) approval of additional spine surgery indications for Infuse Bone Graft more

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The US Food and Drug Administration (FDA) has approved US commercial availability of the MyCareLink Smart Monitor and app-based remote monitoring system for patients with implantable pacemakers more

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