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Regulatory front for Jan. 10, 2020

Jan. 10, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Abbott gets FDA nod for less invasive LVAD implant procedure, as it aims to broaden use

Jan. 10, 2020
By Stacy Lawrence
In the latest step toward making left ventricular assist devices (LVADs) easier and more accessible, the FDA recently approved a less invasive surgical approach for use with Abbott Laboratories’ latest LVAD, Heartmate 3. Now, rather than requiring risky open-heart surgery, the device can be implanted through an incision in the chest wall. Abbott gained Heartmate 3 in its 2017 acquisition of St. Jude Medical for $25 billion.
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GIST kissed ahead of V-Day PDUFA, Blueprint design plan for Ayvakit goes ‘fourth’

Jan. 10, 2020
By Randy Osborne
Cambridge, Mass.-based Blueprint Medicines Corp.’s price tag and label for Ayvakit (avapritinib) caused some chagrin on Wall Street as observers continued to weigh the drug’s odds against ripretinib, the competing drug for which Deciphera Pharmaceuticals Inc. awaits regulatory action.
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French flags on building

Control of medical devices in France severely criticized by the Cour des comptes

Jan. 10, 2020
By Bernard Banga
PARIS – The Cour des comptes, supreme body for auditing the use of public funds in France, independent from government and parliament, has just released its report on the operation of the French National Agency for the Safety of Medicines and Health Products (ANSM). Following 10 months of administrative and financial investigation, these financial controllers have highlighted the weakness of controls applied to medical devices placed on the market in France.
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Regulatory front for Jan. 10, 2020

Jan. 10, 2020
The latest global regulatory news, changes and updates affecting biopharma.
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FDA approves Ayvakit for unresectable or metastatic PDGFRA exon 18 mutant GIST

Jan. 10, 2020

Regulatory front for Jan. 9, 2020

Jan. 9, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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1-9-Microvention-Fred.png

Microvention scores FDA nod for new aneurysm flow diverter

Jan. 9, 2020
By Meg Bryant
The U.S. has granted final approval to Microvention Inc., a subsidiary of Terumo Corp. based in Aliso Viejo, Calif., for its Flow Redirection Endoluminal Device (FRED) for the treatment of brain aneurysms. The flow diverter – Microvention’s third PMA approval in less than two years – is the first in the U.S. to utilize a self-expanding, braided nitinol mesh to aid in rerouting blood flow away from the weakened area and promote occlusion.
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Medtronic gets CE mark for DBS system that tracks brain signals, as it undergoes FDA review

Jan. 9, 2020
By Stacy Lawrence
Dublin-based Medtronic plc received a CE mark for its Percept PC neurostimulator to treat neurologic disorders such as Parkinson’s disease. It is the first deep brain stimulation system launched in the EU that integrates the company’s technology to sense and record brain signals, known as Brainsense. It’s intended to enable more personalized treatment driven by that data.
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Jenavalve snares breakthrough device designation for flagship TAVR device

Jan. 9, 2020
By Mark McCarty
Jenavalve Technology Inc., of Irvine, Calif., has won an FDA breakthrough device designation for its namesake transcatheter aortic valve replacement device, but Jenavalve said it will file for a humanitarian device exemption in the second half of 2020, suggesting that the device won’t be commercially available for at least another year.
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