FDA approvals
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FDA advisory panel vote against approving Biogen’s drug for Alzheimer’s
The nonbinding panel recommendation to reject the drug goes against what FDA scientists presented but they throw up another obstacle for the drug, which is trying to succeed on a front where others have failed.
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More options for psoriasis, as Big Pharma jostles for market share
Coming soon to a screen near you: more psoriasis ads. FDA has approved J&J’s guselkumab (Tremfya) for use in moderate to severe plaque psoriasis. Despite plenty of competition, annual sales are expected to be north of $1 billion by 2022.
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Newly approved cardiac stent may provide alternative for some patients
CeloNova Biosciences has received FDA approval for a new nanocoated polymer stent that has shown low thrombosis rates, a life-threatening complication of stenting.
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Devices & Diagnostics, Hospitals
FDA device approval: Abbott gets a nod for less invasive mitral valve repair technology
Abbott Labs (ABT) announced it received FDA approval for MitraClip, a less-invasive mitral valve repair […]
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Devices & Diagnostics, Hospitals
3-D St. Jude Medical launches technology that gives docs real-time, 360-degree view of arteries
St. Jude Medical (STJ) announced FDA approval of its ILUMIEN OPTIS PCI Optimization System, and […]
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Devices & Diagnostics, Startups
FDA advisory panel gives mixed message to STJ fave CardioMEMS on CHAMPION implantable device
After a difficult premarket approval process and tenuous relationship with the FDA, Atlanta’s CardioMEMS received […]
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Devices & Diagnostics, Diagnostics, Startups
Biotronik receives FDA device approval for ‘smaller, thinner’ one-lead implantable cardiac defibrillator
Biotronik, an Oregon-based cardiovascular medical device company, announced it received final FDA device approval for […]
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Trayt Health Seeks to Increase Access to Diagnoses and Treatments
CEO Malekeh Amini explains how Trayt Health can bridge the gap for patients seeking neurological care.
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Devices & Diagnostics, Health IT, Hospitals, Policy, Startups
Will FDA step in with lab development tests?
In her speech at Advamed 2013, FDA Commissioner Dr. Margaret Hamburg said a new challenge […]
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Devices & Diagnostics, Hospitals
BSX gets FDA approval for ablation catheter, becomes third major player this week with ablation milestone
Boston Scientific (BSX) announced it has received U.S. Food and Drug Administration approval for its […]
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Devices & Diagnostics, Hospitals
FDA approves St. Jude’s ablation catheter for MediGuide platform
EP mapping (and the catheters that go with them) continues to be a hot topic […]
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Fight wrinkles and an overactive bladder using the same FDA-approved treatment: Botox
Wonders never cease. The Food and Drug Administration announced Friday that it was expanding the […]
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Devices & Diagnostics, Hospitals, Startups
FDA approves Dune Medical Devices’ novel breast cancer detection device
Medical device maker Dune Medical Devices announced Wednesday that the company has received a pre-market […]
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Devices & Diagnostics, Hospitals, Startups
FDA approves cardiac assist device for heart failure patients awaiting transplant
The Food and Drug Administration announced Tuesday that it has approved Framingham, Massachussetts-based HeartWare’s left […]