medical device guru

Surgery and Surgical Robotics
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...
January 15, 2019
Orthopedics and Spine
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...
January 14, 2019
Surgery and Surgical Robotics
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...
January 10, 2019
Resource Library
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,)...
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
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