medical device guru

Orthopedics and Spine

FDA Approves Abbott’s “Low Dose,” Recharge-Free Spinal Cord Stimulation System with up to Ten Year Battery Life

Abbott announced the U.S. Food and Drug Administration (FDA) has approved the company’s Proclaim XR™ recharge-free neurostimulation system for people living with chronic pain. The Proclaim XR platform offers a low dose of Abbott’s proprietary BurstDR™ stimulation waveform, which was...

October 1, 2019

Surgery and Surgical Robotics

Neocis Announces FDA 510(k) Clearance of Additional Drill for Use with Yomi® 

Neocis, Inc., the leader and innovator in dental implant surgery using advanced robotics, today announced a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new dental drill for use with Yomi. This new clearance leads to...

October 1, 2019

Imaging Visualization & Navigation

Brainlab Introduces Mobile Intraoperative Imaging Robot 

Brainlab, the digital medical technology company, unveiled Loop-X™, the first mobile intraoperative imaging robot today at NASS 2019 in Chicago. Loop-X sits at the core of the Brainlab Digital Surgery portfolio for the rapidly evolving spinal market. Brainlab is leveraging its...

September 30, 2019

Imaging Visualization & Navigation

Samsung to Unveil New Premium Ultrasound System at Society of Diagnostic Medical Sonography Conference of 2019 

NeuroLogica, a subsidiary of Samsung Electronics Co. Ltd., announced that the Samsung Hera I10 ultrasound system has received FDA clearance and will be unveiled at the Society of Diagnostic Medical Sonography (SDMS) 2019 Annual Conference in National Harbor, MD. The Hera I10...

September 30, 2019

Surgery and Surgical Robotics

FDA Grants Breakthrough Status to Aurora’s Concussion Treatment

There were 2.5 million emergency department visits related to traumatic brain injuries in the U.S. in 2014, according to the Centers for Disease Control and Prevention (CDC). Trends seen in the run up to 2014, the last year on which CDC has...

September 26, 2019

Surgery and Surgical Robotics

Ethicon Launches Industry’s First Powered Circular Stapler

To help address a serious complication associated with colorectal, gastric and thoracic surgery, Johnson & Johnson Medical Devices Companies* announced today that Ethicon** has launched the industry’s first powered circular stapler. The ECHELON CIRCULAR Powered Stapler reduces leaks by 61%...

September 26, 2019

Surgery and Surgical Robotics

Ambulatory Surgery Center Growth Accelerates: Is Medtech Ready?

An increase in the number of surgical procedures taking place at ambulatory care centers could change the playing field for medtech companies, according to a new report by Bain & Co. The management consulting firm predicted that procedures at these stand-alone centers...

September 26, 2019

Surgery and Surgical Robotics

First Portable Brain-Computer Interface to Control Wheelchairs, TVs, Computers 

Brain-computer interfaces have the potential to give severely disabled people the ability to easily control their wheelchairs, televisions, and other devices. Existing technologies suffer from a number of limitations, though, making them impractical for real-world applications. One is that non-invasive...

September 25, 2019

Diagnostics & Healthcare News

FDA Continues to Take Steps to Fulfill its Commitment to Strengthen and Modernize the 510(k) Medical Device Program 

The U.S. Food and Drug Administration today announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies...

September 25, 2019