Group items tagged #Food_and_Drug_Administration - Business Issues

AngioDynamics to study NanoKnife in pancreatic cancer - 0 views

www.medicaldevice-network.com/...oknife-pancreatic-cancer-study

#Angio_Dynamics #Pancreatic_Cancer #Nanoknife_System #FDA #Food_and_Drug_Administration #investigational_Device_Exemption

shared by jacob logan on 03 Apr 19 - No Cached

jacob logan on 03 Apr 19

AngioDynamics has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) application of its NanoKnife System in the treatment of stage III pancreatic cancer.

<div class="cArrow"> </div><div class="cContentInner">AngioDynamics has received approval from the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) application of its NanoKnife System in the treatment of stage III pancreatic cancer.</div>

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Avanos Medical to reduce opioid use with pain management pump - 0 views

www.medicaldevice-network.com/...edical-onq-bolus-fda-clearance

#Avanos_Medical #Management_Pump #Food_and_Drug_Administration #FDA #Management_Device #Post_Operative

shared by jacob logan on 08 Apr 19 - No Cached

jacob logan on 08 Apr 19

Avanos Medical has secured US Food and Drug Administration (FDA) 501(k) clearance for its postoperative pain management device ON-Q Bolus.

<div class="cArrow"> </div><div class="cContentInner">Avanos Medical has secured US Food and Drug Administration (FDA) 501(k) clearance for its postoperative pain management device ON-Q Bolus.</div>

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FDA rejects Helius Medical Technologies' PoNS device - 0 views

www.medicaldevice-network.com/...cts-helius-medical-pons-device

#FDA_rejects #Food_and_Drug_Administration #Helius_Medical_Techonology #Portable_Neuromodulation_Stimulator

shared by jacob logan on 12 Apr 19 - No Cached

jacob logan on 12 Apr 19

The US Food and Drug Administration (FDA) has rejected Helius Medical Technologies' premarket submission for the Portable Neuromodulation Stimulator (PoNS) device due to a lack of data.

<div class="cArrow"> </div><div class="cContentInner">The US Food and Drug Administration (FDA) has rejected Helius Medical Technologies' premarket submission for the Portable Neuromodulation Stimulator (PoNS) device due to a lack of data.</div>

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Biotronik receives FDA approval for new cardiac devices - 0 views

www.medicaldevice-network.com/...iotronik-receives-fda-approval

#Biotronik_Receives_FDA #New_Cardiac_Devices #Cardiac_Rhythm_Management #Food_and_Drug_Administration

shared by jacob logan on 18 Mar 19 - No Cached

jacob logan on 18 Mar 19

Biotronik has secured approval from the US Food and Drug Administration (FDA) for the use of its Acticor and Rivacor cardiac rhythm management (CRM) devices to treat heart arrhythmias.

<div class="cArrow"> </div><div class="cContentInner">Biotronik has secured approval from the US Food and Drug Administration (FDA) for the use of its Acticor and Rivacor cardiac rhythm management (CRM) devices to treat heart arrhythmias.</div>

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Omron Healthcare introduces blood pressure monitor with EKG capability - 0 views

www.medicaldevice-network.com/...mron-healthcare-bp-monitor-ekg

#Omron_Healthcare #Blood_Pressure_Monitor #EKG_Capability #Blood_Pressure #Food_And_Drug_Administration #New_Device _Feature

shared by jacob logan on 06 May 19 - No Cached

jacob logan on 06 May 19

Omron Healthcare has launched a new FDA-approved blood pressure monitor, named Complete, with EKG capability.Developed in alliance with AliveCor, the new device features an upper arm cuff for simultaneous monitoring of blood pressure and EKG readings at home.

<div class="cArrow"> </div><div class="cContentInner">Omron Healthcare has launched a new FDA-approved blood pressure monitor, named Complete, with EKG capability.Developed in alliance with AliveCor, the new device features an upper arm cuff for simultaneous monitoring of blood pressure and EKG readings at home.</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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FDA approves Gore Tag Conformable Thoracic Stent Graft - 1 views

www.medicaldevice-network.com/...gore-tag-conformable-fda-nod

#Food_and_Drug_Administration #material_Sciences #Thoracic_Endovascular_Aortic_repair #Thoracic_Stent_Graft