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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...

January 9, 2019

Biologics, Wound Care, Infection Prevention

FDA 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...

January 7, 2019

Surgery and Surgical Robotics

Titan 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...

January 3, 2019

Diagnostics & Healthcare News

Teva’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,...

January 2, 2019

Surgery and Surgical Robotics

BrainScope 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,...

January 2, 2019

Surgery and Surgical Robotics

TransEnterix Prepping for a $75M Offering

TransEnterix is planning for an upcoming $75 million offering, according to a recently posted SEC filing. The Research Triangle Park, N.C.-based company said that Stifel, Nicolaus & Company will serve as its sale agent in the offering, but the company has...

December 31, 2018

Diagnostics & Healthcare News

Boston Scientific Exercises Option to Buy Millipede for $325M

Nearly a year after bagging the option to acquire Millipede, Boston Scientific has pulled the trigger. When the pair inked the agreement in January, Boston Scientific handed over $90 million for a portion of the mitral regurgitation startup’s shares. Now,...

December 28, 2018

Diagnostics & Healthcare News

Acorda’s Inhaled Parkinson’s Therapy Device Wins FDA Nod

Acorda Therapeutics said this week that the FDA approved its Inbrija device for the intermittent treatment of  “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes...

December 26, 2018

Diagnostics & Healthcare News

False-Positive Mammograms Increase a Woman’s Breast Cancer Risk

Women who experience false-positive mammograms are at an increased risk of breast cancer for more than a decade, according to new research published in the British Journal of Cancer. The authors collected data from more than 1.1 million women from three population-based screening...

December 20, 2018