FDA Grants 510(k) Clearance to electroCore’s Vagus Nerve Stimulator

https://www.fdanews.com/articles/204425-fda-grants-510k-clearance-to-electrocores-vagus-nerve-stimulator

Rehabtronics Gets 510(k) Clearance for Neurostimulation Device

https://www.fdanews.com/articles/204282-rehabtronics-gets-510k-clearance-for-neurostimulation-device

FX Shoulder USA Gets 510(k) Clearance for Shoulder Arthroplasty Devices

https://www.fdanews.com/articles/204195-fx-shoulder-usa-gets-510k-clearance-for-shoulder-arthroplasty-devices

Helius Medical Technologies’ Stroke Device Gets FDA Breakthrough Designation

https://www.fdanews.com/articles/204074-helius-medical-technologies-stroke-device-gets-fda-breakthrough-designation

Stryker’s Balloon Implant for Rotator Cuff Tears Cleared

https://www.fdanews.com/articles/203720-strykers-balloon-implant-for-rotator-cuff-tears-cleared

NeuroMetrix’s Fibromyalgia Device Deemed Breakthrough Device
https://www.fdanews.com/articles/203651-neurometrixs-fibromyalgia-device-deemed-breakthrough-device
Gnomon Informatics Gets CE Mark for Medical Device Software
https://www.fdanews.com/articles/203564-gnomon-informatics-gets-ce-mark-for-medical-device-software
SeaSpine Gets 510(k) Clearance for Spinal Surgery Module
https://www.fdanews.com/articles/203499-seaspine-gets-510k-clearance-for-spinal-surgery-module
FDA Approves Angel Medical Systems’ Cardiac Monitoring Device
https://www.fdanews.com/articles/203375-fda-approves-angel-medical-systems-cardiac-monitoring-device
TGA to Ease Requirements for Some Personalized Devices

https://www.fdanews.com/articles/203250-tga-to-ease-requirements-for-some-personalized-devices?v=preview

Apyx Medical Files 510(k) for Dermal Resurfacing Device

https://www.fdanews.com/articles/202987-apyx-medical-files-510k-for-dermal-resurfacing-device

Wise’s Single-Use Cortical Strip CE Marked
https://www.fdanews.com/articles/202908-wises-single-use-cortical-strip-ce-marked
Axonics’ Sacral Neurostimulator Cleared in Europe
https://www.fdanews.com/articles/202815-axonics-sacral-neurostimulator-cleared-in-europe
FDA clears Life Spine’s ProLift lateral HELO fixation system
https://www.massdevice.com/fda-clears-life-spines-prolift-lateral-helo-fixation-system/
Biobeat Gains CE Mark for Remote Patient Monitoring System
https://www.fdanews.com/articles/202623-biobeat-gains-ce-mark-for-remote-patient-monitoring-system
DJO Acquires Foot and Ankle Devicemaker MedShape
https://www.fdanews.com/articles/202508-djo-acquires-foot-and-ankle-devicemaker-medshape
Aliadas del sistema nervioso
https://www.elespectador.com/noticias/salud/aliadas-del-sistema-nervioso/
Chemence Medical Gets 510(k) Clearance for Overhauled Skin-Closure System
https://www.fdanews.com/articles/202256-chemence-medical-gets-510k-clearance-for-overhauled-skin-closure-system
Bioventus Purchases Neuromodulation Device Firm Bioness
https://www.fdanews.com/articles/202196-bioventus-purchases-neuromodulation-device-firm-bioness
Catalyst OrthoScience Receives FDA 510(k) Clearance Of Its Reverse Shoulder System
https://www.catalystortho.com/2021/03/17/catalyst-orthoscience-receives-510k-clearance-of-its-reverse-shoulder-system/
ControlRad’s Imaging System Radiation Reducer Cleared
https://www.fdanews.com/articles/201747-controlrads-imaging-system-radiation-reducer-cleared
Empirical Spine Seeks Premarket Approval for Spinal Fusion Alternative
https://www.fdanews.com/articles/201582-empirical-spine-seeks-premarket-approval-for-spinal-fusion-alternative
FDA Approves 3D-Printed Talus Implant for Humanitarian Use
https://www.fdanews.com/articles/201445-fda-approves-3d-printed-talus-implant-for-humanitarian-use
U.S. Joins WHO’s ACT Accelerator Program for Pandemic Response
https://www.fdanews.com/articles/201380-us-joins-whos-act-accelerator-program-for-pandemic-response?v=preview
GE Healthcare Sells Off Breast-Imaging System to SmartBreast
https://www.fdanews.com/articles/201286-ge-healthcare-sells-off-breast-imaging-system-to-smartbreast
Becton Dickinson’s TBNK Multitest Cleared for High-Risk COVID Patients
https://www.fdanews.com/articles/201204-becton-dickinsons-tbnk-multitest-cleared-for-high-risk-covid-patients
AOT’s Robotic Bone-Cutting Laser Cleared in Europe
https://www.fdanews.com/articles/200952-aots-robotic-bone-cutting-laser-cleared-in-europe
Immunity against SARS-CoV-2 may last at least 8 months
https://www.medicalnewstoday.com/articles/immunity-against-sars-cov-2-may-last-at-least-8-months
FDA Continues to Take Action Against Unapproved COVID-19 Tests
https://www.fdanews.com/articles/200479-fda-continues-to-take-action-against-unapproved-covid-19-tests
FDA Expands EUA for Rheonix’s COVID-19 Assay
https://www.fdanews.com/articles/200367-fda-expands-eua-for-rheonixs-covid-19-assay
FDA Call for Safety Details in Electromagnetic Device Applications
https://www.fdanews.com/articles/200182-fda-call-for-safety-details-in-electromagnetic-device-applications
Siemens Healthineers’ COVID-19 Test Gets CE Mark
https://www.fdanews.com/articles/200104-siemens-healthineers-covid-19-test-gets-ce-mark
Ortho Clinical Earns CE Mark for Thyroid Disorder Assay
https://www.fdanews.com/articles/200037-ortho-clinical-earns-ce-mark-for-thyroid-disorder-assay
FDA Accepts Ortho Clinical’s EUA Request for COVID-19 Test

The FDA has accepted Ortho Clinical’s Emergency Use Authorization request for the Vitros SARS-CoV-2 Antigen test, a COVID-19 diagnostic that’s already been cleared in Europe.

Medicare to Cover CVRx’s Heart Failure Neurostimulation Device
https://www.fdanews.com/articles/199847-medicare-to-cover-cvrxs-heart-failure-neurostimulation-device
FDA Clears Orthofix’s Bone-Screw System for Sacroiliac Joint Dysfunction

https://www.fdanews.com/articles/197849-fda-clears-orthofixs-bone-screw-system-for-sacroiliac-joint-dysfunction

Miracor Medical’s PiCSO Impulse System Earns CE Mark

https://www.fdanews.com/articles/197762-miracor-medicals-picso-impulse-system-earns-ce-mark

GE Healthcare launches chest X-ray AI to better spot COVID-19
https://www.massdevice.com/ge-healthcare-launches-chest-x-ray-ai-to-better-spot-covid-19/
Siemens Healthineers wins EUAs for additional COVID-19 antibody tests
https://www.massdevice.com/siemens-healthineers-wins-euas-for-additional-covid-19-antibody-tests/
FDA warns of cyanide gas danger with improper use of Hologic COVID-19 tests
https://www.massdevice.com/fda-warns-of-cyanide-gas-danger-with-improper-use-of-hologic-covid-19-tests/
Spine, cancer doc leaders among top recipients of device, drug industry funds, analysis finds

https://www.medtechdive.com/news/spine-cancer-doc-leaders-among-top-recipients-of-device-drug-industry-fun/578779/

BioMérieux’s COVID-19 Antibody Tests Obtain CE Mark

https://www.fdanews.com/articles/197245-biom%C3%A9rieuxs-covid-19-antibody-tests-obtain-ce-mark

FDA Allows Emergency Use of Infusion Pumps for COVID-19 Response

https://www.fdanews.com/articles/197206-fda-allows-emergency-use-of-infusion-pumps-for-covid-19-response

Olympic Ophthalmics wins FDA nod for iTEAR100 neurostimulator
https://www.massdevice.com/olympic-ophthalmics-wins-fda-clearance-for-itear100-neurostimulator/
FDA authorizes Quidel antigen test for rapid COVID-19 detection
https://www.massdevice.com/fda-authorizes-quidel-antigen-test-for-rapid-covid-19-detection/
Cleanbox launches UV-C mask decontamination device
https://www.massdevice.com/cleanbox-launches-uv-c-mask-decontamination-device/
Siemens Healthineers Develops COVID-19 Antibody Test

https://www.fdanews.com/articles/196804-siemens-healthineers-develops-covid-19-antibody-test

Coronavirus disease (COVID-19) Pandemic

https://www.who.int/emergencies/diseases/novel-coronavirus-2019

Biotronik Earns CE Mark for Drug-Eluting Stent

https://www.fdanews.com/articles/195971-biotronik-earns-ce-mark-for-drug-eluting-stent

It’s official: EC confirms 2-year Eudamed delay

https://www.medtechdive.com/news/it-is-official-ec-confirms-2-year-eudamed-delay/566161/

Active Implants wins breakthrough nod for NUsurface knee implant
https://www.massdevice.com/active-implants-wins-breakthrough-nod-for-nusurface-knee-implant/
CVS launches home hemodialysis device clinical trial

https://www.medtechdive.com/news/cvs-launches-home-hemodialysis-device-clinical-trial/558944/

Silicone Materials for Long-term Medical Implants: Innovate for the Future
https://www.massdevice.com/silicone-materials-for-long-term-medical-implants-innovate-for-the-future/
Bacteria engineered as Trojan horse for cancer immunotherapy

https://www.sciencedaily.com/releases/2019/07/190703121442.htm

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    BOGOTA, COLOMBIA
    Avenue 67 No 167-61 Colina Office Park
    Phones: 57 (1) 6714266 – (1) 6718655 – (1) 6680827

    BUCARAMANGA, COLOMBIA
    Industrial Park C Block, Cellar 10
    PBX 57 (7) 6861915 FAX: 57 (7) 67691377