medical device guru

Biologics, Wound Care, Infection Prevention
AIROS Medical Launches New Compression Therapy Device and Garment System to Treat Breast Cancer Patients
AIROS® Medical, Inc., a medical technology manufacturer specializing in compression therapy products that treat cancer-related lymphedema and venous complications, today announced the launch of its updated AIROS 6 Sequential Compression Therapy device and Arm Plus garments following multiple regulatory approvals....
May 28, 2020
Surgery and Surgical Robotics
Gynesonics Receives FDA Clearance to Market Next Generation Sonata System 2.1 
Gynesonics, a women’s healthcare company focused on the development of minimally-invasive solutions for symptomatic uterine fibroids, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its next generation Sonata® System 2.1...
May 28, 2020
Cardiovascular / Cardiology
Neovasc Has Filed for CE Mark for Tiara TA Transapical Mitral Valve Replacement System
Neovasc, Inc., a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina, today announced that the Company has filed for CE Mark for its Tiara TA Transapical...
May 27, 2020
Orthopedics and Spine
Centinel Spine Announces FDA Approval for the Manufacturing Transfer of prodisc Technology
Centinel Spine, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced FDA approval for the manufacturing transfer of both the prodisc® C Cervical Total Disc Replacement and prodisc® L Lumbar Total Disc Replacement systems to new strategic vendors. The FDA...
May 27, 2020
Biologics, Wound Care, Infection Prevention
STERIS Announces Second On-site Decontamination Solution for Respiratory Masks
STERIS plc announced that the U.S. Food and Drug Administration (FDA) has issued another Emergency Use Authorization (EUA) for respirator decontamination.  The EUA enables healthcare providers to decontaminate surgical N95 respirators by utilizing certain AMSCO Steam Sterilizers that have been...
May 26, 2020
Surgery and Surgical Robotics
SMART Medical Systems Receives FDA Clearance for Its G-EYE Colonoscope
SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced that the FDA issued 510(k) clearance for its flagship product, the G-EYE® Colonoscope. The G-EYE® colonoscope is a standard colonoscope which SMART remanufactures by installing its proprietary G-EYE® balloon on...
May 26, 2020
Imaging Visualization & Navigation
Philips Receives FDA Clearance for the Use of its Ultrasound Portfolio to Manage COVID-19-Related Complications
Royal Philips, a global leader in health technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a wide range of its ultrasound solutions for the management of COVID-19-related lung and...
May 21, 2020
Diagnostics & Healthcare News
FDA Approves Emergency Use of A&R Tarpaulins’ Patient Isolation Transportation Unit (PITU) 
AR Tech, a division of A&R Tarpaulins Inc., an aerospace and medical equipment manufacturer, received emergency approval for the use of its Patient Isolation Transportation Unit (PITU) by the Food and Drug Administration. PITU is designed to temporarily isolate and transport...
May 21, 2020
Orthopedics and Spine
Smith & Nephew launches new JOURNEY II Unicompartmental Knee System
Smith+Nephew, the global medical technology business, today announces the launch of its new JOURNEY II Unicompartmental Knee (UK) System. Built on the heritage of one of the most clinically successful partial knees,1,2 and paired with proprietary OXINIUM™ Technology, JOURNEY II UK is...
May 20, 2020
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