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Regulatory Roundup

Recall: Nidek pulls oxygen concentrators over nursing home fires | Regulatory Roundup

June 20, 2012 By MassDevice staff

MassDevice.com Regulatory Roundup

 House, nursing home fires spur Nidek oxygen concentrator recall
Alabama-based oxygen devices maker Nidek Medical pulled its Mark5 Nuvo oxygen concentrators off of shelves after receiving reports of fires in homes and nursing homes, according to an FDA release.

Filed Under: Food & Drug Administration (FDA), News Well, Optical/Ophthalmic, Respiratory Tagged With: Bausch + Lomb, MicroMed Cardiovascular Inc., Nidek, Regulatory Roundup

FDA clears St. Jude’s Amplatzer catheter-based vascular plug | Regulatory Roundup

June 18, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 St. Jude lands FDA OK for transcatheter vascular plug

Filed Under: 510(k), News Well, Recalls Tagged With: LensAR Inc., Regulatory Roundup, Sigma International General Medical Supply, stjudemedical

Mazor’s surgical robot clears regulatory hurdles in Korea | Regulatory Roundup

June 15, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 Mazor lands Korean approval for Renaissance spinal surgery robot

Filed Under: News Well, Robotics Tagged With: Kinetic Concepts Inc., mazorrobotics, Regulatory Roundup, Siemens

Nexstim wins FDA OK for pre-neurosurgery speech mapping | Regulatory Roundup

June 13, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 Nexstim lands FDA clearance for non-invasive speech mapping

Filed Under: News Well Tagged With: Mauna Kea Technologies, Nexstim, Regulatory Roundup, SomnoMed

ETView touts FDA win for Viva endobronchial blockers | Regulatory Roundup

June 12, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

ETView lands FDA clearance for endobronchial blocker

Filed Under: News Well Tagged With: ETView Medical, Melicor Medical, Neurotech, Regulatory Roundup

Mevion lands FDA 510(k) for proton therapy system | Regulatory Roundup

June 12, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 Mevion Medical wins FDA 510(k) clearance for Mevion S250 proton therapy systems

Filed Under: News Well Tagged With: Allied Healthcare Products, Mevion Medical Systems, Regulatory Roundup, Toshiba

NinePoint lands CE Mark for endomicroscopic imaging system | Regulatory Roundup

June 6, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 NinePoint Medical touts CE Mark for NvisionVLE imaging system

Filed Under: News Well Tagged With: Arteriocyte, NinePoint Medical Inc., pSivida Corp., Regulatory Roundup

Neuronetics’ depression therapy device wins CE Mark | Regulatory Roundup

June 5, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 Neuronetics lands CE mark for neurostim depression therapy

Filed Under: 510(k), Neuromodulation/Neurostimulation, News Well Tagged With: Erchonia Corp., Neuronetics, Regulatory Roundup, Siesta Medical

Boston Scientific lands FDA win for new stent lengths | Regulatory Roundup

June 4, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 Boston Scientific lands FDA win for new stent sizes

Filed Under: Drug-Eluting Stents, Food & Drug Administration (FDA), Neuromodulation/Neurostimulation, News Well, Replacement Heart Valves Tagged With: Boston Scientific, MitrAssist Medical, Nevro Corp., Regulatory Roundup

Medicrea touts FDA win for LigaPass screw-free spinal implant | Regulatory Roundup

June 1, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 Medicrea lands FDA win for LigaPass spinal implant

Filed Under: Food & Drug Administration (FDA), News Well, Spine Tagged With: Medicrea Group, Regulatory Roundup, Royer Biomedical, Tissue Therapies

ViewRay touts FDA’s OK for MRI guided radiotherapy | Regulatory Roundup

May 31, 2012 By MassDevice staff Leave a Comment

MassDevice.com Regulatory Roundup

 ViewRay lands 510(k) for MRI-guided radiation therapy

Filed Under: 510(k), Food & Drug Administration (FDA), News Well, Oncology Tagged With: BioCer Entwicklungs, Injex Pharma, Regulatory Roundup, ViewRay Inc.

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