medical device guru

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

Diagnostics & Healthcare News

New Ergotron CareFit Pro Medical Cart Improves Caregiver Comfort, Efficiency 

The new CareFit™ Pro Medical Cart from Ergotron can help improve caregiver comfort, streamline workflows and create better patient experiences. Developed based on years of research and insights from caregivers, CareFit Pro combines a highly mobile and adjustable design with a broad...

May 20, 2020

Cardiovascular / Cardiology

Thermedical’s Groundbreaking SERF Ablation System Earns FDA’s Breakthrough Device Designation

Thermedical®, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate® catheter....

May 19, 2020

Imaging Visualization & Navigation

Butterfly Network, Inc. is Bringing Ultrasound into the Home with Telemedicine

Butterfly Network has developed and is rolling out a new version of TeleGuidance™, their ultrasound-based telemedicine platform. TeleGuidance brings medical imaging to telemedicine. It leverages an array of leading-edge and easy-to-use augmented reality guiding tools. It allows trained practitioners to...

May 18, 2020

Orthopedics and Spine

Zebra Medical Vision Secures its 5th FDA Clearance, Making Its Vertebral Compression Fractures AI Solution Available in the U.S.

Zebra Medical Vision, the deep-learning medical imaging analytics company, announces today its fifth FDA 510(k) clearance for its Vertebral Compression Fractures (VCF) product. The company’s latest AI solution automatically identifies findings suggestive of compression fractures, enabling clinicians to place patients...

May 18, 2020

Diagnostics & Healthcare News

FDA and CDC Drawing Up Plan to Restart Routine Facility Inspections

Amid the coronavirus outbreak reaching pandemic level in March, FDA stopped routine inspections of domestic and international facilities. Under the revised policy, the agency would perform inspections seen as “mission critical” while relying on off-site monitoring and the commitment of...

May 14, 2020

Surgery and Surgical Robotics

Nevro Announces CE Mark Approval of Senza Omnia Spinal Cord Stimulation System to Treat Chronic Pain

Nevro Corp., a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced it has received CE mark approval for the Senza® Omnia™ Spinal Cord Stimulation (SCS) system. “Following a successful launch in the...

May 14, 2020

Diagnostics & Healthcare News

Abbott Receives FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity i System

Abbott announced today that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity™ i system. Abbott plans to ship nearly 30 million antibody tests globally in...

May 13, 2020

Cardiovascular / Cardiology

FDA Issues Emergency Use Authorization for Eko’s ECG-based Low Ejection Fraction Screening Algorithm, Designed to Improve Detection of Heart Failure During COVID-19 Pandemic

Eko, a digital health company building AI-powered screening and telehealth solutions to fight cardiovascular disease, today announced that the U.S. Food and Drug Administration (FDA) has issued the company an Emergency Use Authorization (EUA) for its novel ECG-based algorithm that can provide...

May 13, 2020