Group items tagged #US_Food - Diigo Community

FDA approves Innoblative's radiofrequency ablation device - 0 views

www.medicaldevice-network.com/...ive-designs-rf-ablation-device

#Food_and_Drug_Administration #FDA #US_FOod #Radio_Frequency #Radio_Frequency_Ablation_Device #Electrosurgical_Device

shared by jacob logan on 12 Apr 19 - No Cached

jacob logan on 12 Apr 19

The US Food and Drug Administration (FDA) has granted clearance to Innoblative Designs' electrosurgical device SIRA RFA.

<div class="cArrow"> </div><div class="cContentInner">The US Food and Drug Administration (FDA) has granted clearance to Innoblative Designs' electrosurgical device SIRA RFA.</div>

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Boston Scientific gets FDA approval for LOTUS Edge system - 0 views

www.medicaldevice-network.com/...ientific-lotus-edge-system-nod

#Boston_Scientific #FDA #Food_and_Drug_Administration #Lotus_Adge #US_Food #Lotus_Adge_System

shared by jacob logan on 25 Apr 19 - No Cached

jacob logan on 25 Apr 19

Boston Scientific has received the US Food and Drug Administration (FDA) approval for the use of LOTUS Edge Aortic Valve System to treat severe aortic stenosis.

<div class="cArrow"> </div><div class="cContentInner">Boston Scientific has received the US Food and Drug Administration (FDA) approval for the use of LOTUS Edge Aortic Valve System to treat severe aortic stenosis.</div>

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Paige.AI gets breakthrough status for cancer diagnosis solution - 0 views

www.medicaldevice-network.com/...ge-ai-breakthrough-designation

#Artificial_Intelligence #Cancer_Diagnosis #Cancer #AI #Device #US_Food #FDA

shared by jacob logan on 13 Mar 19 - No Cached

jacob logan on 13 Mar 19

Paige.AI has received breakthrough device designation from the US Food and Drug Administration (FDA) for a cancer diagnosis solution based on artificial intelligence (AI).

<div class="cArrow"> </div><div class="cContentInner">Paige.AI has received breakthrough device designation from the US Food and Drug Administration (FDA) for a cancer diagnosis solution based on artificial intelligence (AI).</div>

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Medtronic's Attain Stability left heart lead receives FDA approval - 0 views

www.medicaldevice-network.com/...-attain-stability-gets-fda-nod

#Medtronics_Attain_Stability #heart_Lead #FDA #Food_and_Drug_Administration #US_Food #Precise_Lead_Placement

shared by jacob logan on 06 May 19 - No Cached

jacob logan on 06 May 19

The US Food and Drug Administration (FDA) has granted approval to Medtronic's Attain Stability Quad MRI SureScan left heart lead. The device is the only active-fixation left heart lead, and is designed for precise lead placement and stability.

<div class="cArrow"> </div><div class="cContentInner">The US Food and Drug Administration (FDA) has granted approval to Medtronic's Attain Stability Quad MRI SureScan left heart lead. The device is the only active-fixation left heart lead, and is designed for precise lead placement and stability.</div>

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FDA clears Materialise's cardiovascular planning software - 1 views

www.medicaldevice-network.com/...rdiovascular-planning-software

#Food and Drug #Food_and_Drug_Administration #Planning_Software #Materialse's_Cardiovascular #3D_Printing_Solutions #3D_Printing #US_Food

shared by jacob logan on 18 Jun 19 - No Cached

jacob logan on 18 Jun 19

3D printing solutions provider Materialise has obtained clearance for its Mimics Enlight cardiovascular planning software suite from the US Food and Drug Administration (FDA).

<div class="cArrow"> </div><div class="cContentInner">3D printing solutions provider Materialise has obtained clearance for its Mimics Enlight cardiovascular planning software suite from the US Food and Drug Administration (FDA).</div>

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FDA approves Cochlear Nucleus Profile Plus Series implant - 1 views

www.medicaldevice-network.com/...us-profile-plus-series-implant

#Food_and_Drug_Administration #Cochlear_Nucleus #Series_Implant #Us_Food #FDA

shared by jacob logan on 19 Jun 19 - No Cached

jacob logan on 19 Jun 19

The US Food and Drug Administration (FDA) has approved the new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processor's new built-in connectivity.

<div class="cArrow"> </div><div class="cContentInner">The US Food and Drug Administration (FDA) has approved the new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processor's new built-in connectivity.</div>

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Magnetic hearing devices may interfere with shunt systems, says FDA - 1 views

www.medicaldevice-network.com/...ear-implant-shunt-interference

#Magnetic_Hearing_Device #Shunt_System #FDA #US_Food #Food_and_Drug_Administration #Cerebrospinal_Fluid #Hearing_Device

shared by jacob logan on 19 Jul 19 - No Cached

jacob logan on 19 Jul 19

The US Food and Drug Administration (FDA) has issued a statement warning healthcare providers about potential complications in patients fitted with both programmable cerebrospinal fluid (CSF) shunt systems and certain magnetic hearing devices.

<div class="cArrow"> </div><div class="cContentInner">The US Food and Drug Administration (FDA) has issued a statement warning healthcare providers about potential complications in patients fitted with both programmable cerebrospinal fluid (CSF) shunt systems and certain magnetic hearing devices.</div>

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Formal FDA enforcement action declines under Trump - 1 views

www.medicaldevice-network.com/...g-letters-trump-administration

#Formal_FDA #Declines_Under_Trump #Trump #Compliance_And_Enforcement #Food_and_Drug_Administration #US_Food #Medical_Device

shared by jacob logan on 03 Jul 19 - No Cached

jacob logan on 03 Jul 19

Compliance and enforcement actions by the US Food and Drug Administration (FDA) have dramatically declined under the Trump administration, with medical devices seeing the steepest drop, according to a new report.

<div class="cArrow"> </div><div class="cContentInner">Compliance and enforcement actions by the US Food and Drug Administration (FDA) have dramatically declined under the Trump administration, with medical devices seeing the steepest drop, according to a new report.</div>

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FDA labels Ethicon surgical staplers recall as Class I - 1 views

www.medicaldevice-network.com/...fda-ethicon-staplers-recall

#FDA #Food_and_Drug_Administration #FDA_Labels #Ethicon_Surgical_Staplers #US_Food #Johnson #High_RIsk

shared by jacob logan on 21 May 19 - No Cached

jacob logan on 21 May 19

The US Food and Drug Administration (FDA) has labelled a recall of circular staplers by Johnson & Johnson (J&J) unit Ethicon as Class I, or high risk.

<div class="cArrow"> </div><div class="cContentInner">The US Food and Drug Administration (FDA) has labelled a recall of circular staplers by Johnson & Johnson (J&J) unit Ethicon as Class I, or high risk.</div>

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