Archive for January 2019
Paula’s Predictions for the 2019 MedTech Job Market
THE GLOBAL CANDIDATE-CENTRIC JOB MARKET WILL TURN IN 2019 Paula’s Predictions for the 2019 MedTech Job Market (What candidates and companies should do NOW) THE BAD NEWS If you’ve watched the news in December (or your stock portfolio valuation,) you’ll note that there is a shift in the winds and increased anxiety amongst financial pundits,…
Read MoreFDA Grants De Novo Authorization to Pressure Ulcer Risk Assessment Device
Bruin Biometrics, LLC has been granted U.S. Food and Drug Administration marketing authorization for the SEM Scanner, a wireless handheld device that is indicated for use as an adjunct to the standard of care when assessing patients who are at increased risk for pressure ulcers. The SEM Scanner is the world’s first FDA-authorized device to…
Read MoreTitan Medical’s Sport Robotic System Nearing Commercialization
Titan Medical Inc., a medical device company focused on the design and development of a robotic surgical system for application in minimally invasive surgery, announces that it has completed the system engineering confidence build for all components of its single-port robotic surgery system. This accomplishment highlights the completion of a new camera system along with the…
Read MoreTeva’s Digital Inhaler Now FDA Cleared
Jerusalem-based Teva Pharmaceuticals’ sensor-packed, app-connected digital inhaler has recently received marketing approval from the US FDA, according to a release from the company. The device will first become available next year through a “small number” of healthcare system pilot partnerships, with a full national launch currently planned for 2020. Teva’s ProAir Digihaler is indicated for…
Read MoreBrainScope Receives FDA Clearance for Multi-Parameter Concussion Assessment
BrainScope, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it has received FDA clearance to include additional language in its product’s Indications for Use (IFU), adding key terminology related to “multi-modal, multi-parameter assessment” of “concussion” and “mild Traumatic Brain Injury”, as well as an expanded and…
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