FDA Approved Neuro

Abbott receives expanded indication from FDA for directional DBS to treat Parkinson’s disease

Released on January 25, 2020

Abbott has announced it received approval from the US Food and Drug Administration (FDA) for a new, expanded indication for the […]

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Cardiology FDA Approved

FDA grants Medtronic an IDE to study new tech for ablating heart tissue

Released on January 24, 2020

Medtronic (NYSE:MDT) announced today that it won FDA approval to move forward with an investigational device exemption trial to evaluate the safety […]

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Cardiology FDA Approved

FDA OKs latest Medtronic leadless pacemaker, potentially tripling market

Released on January 22, 2020

Dive Brief: Medtronic said Tuesday it received FDA premarket approval for its Micra AV pacemaker, a device it expects to more […]

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FDA Approved Neuro

Axonics wins FDA approval for enhanced neurostimulator programmer

Released on January 22, 2020

Axonics Modulation Technologies (NSDQ:AXNX) announced today that it won FDA approval for a second-generation programmer for its r-SNM sacral neuromodulation system. The […]

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Cardiology FDA Approved Implants

BREAKING: Medtronic wins FDA approval for Micra AV

Released on January 22, 2020

Medtronic (NYSE:MDT) has won FDA approval for its Micra AV — greatly expanding the number of people who could potentially benefit from […]

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Cardiology FDA Approved Structural Heart

Abbott to Initiate Trial to Study MitraClip as an Option for Moderate Surgical Risk Patients

Released on January 13, 2020

ABBOTT PARK, Ill., Jan. 13, 2020 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved a first-of-its-kind […]

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FDA Approved Neuro Vascular

MicroVention’s FRED flow diverter now FDA approved

Released on January 13, 2020

MicroVention, a US based subsidiary of Terumo and a global neurovascular company announced the US FDA premarket approval (PMA) for the […]

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FDA Approved Gastroenterology

Colospan wins IDE FDA approval for intraluminal bypass device

Released on January 9, 2020

Colospan announced today that it won FDA investigational device exemption for its CG-100 temporary intraluminal bypass device for gastrointestinal resection procedures. Following […]

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Cardiology FDA Approved Structural Heart

Abbott LVAD wins FDA approval for implantation without open heart surgery

Released on January 7, 2020

Abbott (NYSE:ABT) today announced that FDA has approved implantation of its HeartMate 3 LVAD via lateral thoracotomy — a less invasive approach […]

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Cardiology FDA Approved

AtriCure Completes Patient Enrollment for aMAZE Trial

Released on January 7, 2020

AtriCure is rolling into the new year with some significant milestones that help reinforce the presence it has built in the […]

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Cardiology FDA Approved

Terumo subsidiary gains FDA nod for aneurysm flow diverter

Released on January 6, 2020

Dive Brief: FDA awarded premarket approval to Terumo’s MicroVention subsidiary for a flow diversion system to treat wide-neck intracranial aneurysms of […]

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FDA Approved Imaging

FDA clears PhotoniCare’s handheld OCT scanner for checking ear infections

Released on January 6, 2020

PhotoniCare received FDA 510(k) clearance for its hand-held, noninvasive imaging scope that allows physicians to check for fluids deep behind the […]

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