Northwestern Memorial Hospital Performs First US Robotic Lung Volume Reduction Surgery

Northwestern Memorial Hospital is the first in the country to successfully complete robotic-assisted lung volume reduction surgery (LVRS) using the da Vinci Xi Surgical System® to remove diseased, emphysematous tissue within the lungs for the treatment of severe emphysema, a progressive form of chronic obstructive pulmonary disease (COPD). The robotic procedure allows the surgeon to precisely remove the…

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1 in 3 GoFundMe Campaigns are for Medical Bills and That’s a Problem Says GoFundMe CEO

Scrolling through the GoFundMe website reveals seemingly an endless number of people who need help or community support. A common theme: the cost of health care. It didn’t start out this way. Back in 2010, when the crowdfunding website began, it suggested fundraisers for “ideas and dreams,” “wedding donations and honeymoon registry” or “special occasions.”…

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TransEnterix Wins FDA Clearance for Senhance Ultrasonic Instruments

TransEnterix, Inc., a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced the Company received FDA 510(k) clearance for its Senhance Ultrasonic System. “Advanced energy devices are used within a high percentage of cases across a wide range of procedures, which make them a critical tool for…

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OSSIO Receives 501(k) Clearance for Bio-Integrative Bone Pins

The FDA has granted 510(k) clearance to Ossio for its family of bio-integrative bone pins, which secure broken bones during the healing process while leaving no permanent hardware behind. The pins are made of a natural mineral fiber matrix that aims to replace the more permanent, metal fixation implants used in fractures, bone cuttings or…

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IRRAS’s Intracranial Bleeding Management Device Used on First U.S. Patient

IRRAS AB, a commercial-stage medical-technology company, today announced that the first patient in the United States was successfully treated with IRRAflow, the company’s initial product that offers an innovative, therapeutic approach to the fluid management of patients with intracranial bleeding. “The US is the largest market for intracranial procedures, and we are making significant progress engaging neurocritical care centers and specialty hospitals across the country,” said Kleanthis G. Xanthopoulos, Ph.D.,…

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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 note that there is a shift in the winds and increased anxiety amongst financial pundits,…

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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 increased risk for pressure ulcers. The SEM Scanner is the world’s first FDA-authorized device to…

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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 surgery system. This accomplishment highlights the completion of a new camera system along with the…

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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, with a full national launch currently planned for 2020. Teva’s ProAir Digihaler is indicated for…

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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, multi-parameter assessment” of “concussion” and “mild Traumatic Brain Injury”, as well as an expanded and…

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