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