Submissions and Approvals

FDA Schedules Workshop on Virtual and Augmented Reality in Medicine

January 17, 2020

The agency aims to promote development of evaluation techniques for extended reality devices. Read More

FDA Calls on Duodenoscope Makers to Shift to Newer Designs

January 16, 2020

The agency cleared the first fully disposable duodenoscope in December. Read More

Pentax Medical Nabs FDA Clearance for Endoscopy Platform

January 16, 2020

The device features LED lights that eliminate the need for periodic bulb replacements. Read More

TransEnterix Files 510(k) Submission for Senhance Surgical System Addition

January 16, 2020

The addon would improve the system’s eye-tracking camera control. Read More

FDA Clears BioCardia’s Guide Catheter for Biotherapeutic Delivery System

January 16, 2020

The guide catheter improves the use of the Helix system while cell therapy is being delivered. Read More

Cleveland Clinics’ Patient-Specific Airway Stents Cleared

January 15, 2020

The company said its airway stents “have the potential to be more tolerable than traditional silicone stents.” Read More

FDA Grants Carestream 510(k) Clearance for Tomosynthesis Technology

January 15, 2020

Digital tomosynthesis can improve visibility by creating cross-sectional images of an organ. Read More

Medtronic’s Miniature Neurostimulator Grabs CE Mark

January 15, 2020

The company also received the CE Mark for its InterStim SureScan leads, which are used in implants of the Micro system to enable full-body MRI scans. Read More

Hemovent Earns CE Mark for Heart and Lung Machine Controller

January 14, 2020

The device is designed to “slingshot clinicians into a new era of mobility and ease of use,” said Hemovent’s CEO Christof Lenz. Read More

Phagenesis’ Dysphagia Treatment Grabs FDA Breakthrough Device Status

January 14, 2020

Severe dysphagia with insufficient airway protection is the main reason why patients cannot have a tracheostomy tube removed. Read More

MGI’s DNA Sequencers Cleared in Europe, Asia-Pacific Countries

January 14, 2020

The G400/50 sequencers can now be marketed in China, Japan, Australia, Singapore, Malaysia, Thailand and Vietnam. Read More

Paragonix’s Pancreas Transporter Receives FDA Clearance

January 13, 2020

The transporter offers an alternative to the current method of using an ice cooler. Read More

Submissions and Approvals
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FDA Schedules Workshop on Virtual and Augmented Reality in Medicine

FDA Calls on Duodenoscope Makers to Shift to Newer Designs

Pentax Medical Nabs FDA Clearance for Endoscopy Platform

TransEnterix Files 510(k) Submission for Senhance Surgical System Addition

FDA Clears BioCardia’s Guide Catheter for Biotherapeutic Delivery System

Cleveland Clinics’ Patient-Specific Airway Stents Cleared

FDA Grants Carestream 510(k) Clearance for Tomosynthesis Technology

Medtronic’s Miniature Neurostimulator Grabs CE Mark

Hemovent Earns CE Mark for Heart and Lung Machine Controller

Phagenesis’ Dysphagia Treatment Grabs FDA Breakthrough Device Status

MGI’s DNA Sequencers Cleared in Europe, Asia-Pacific Countries

Paragonix’s Pancreas Transporter Receives FDA Clearance

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