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Diagnostics & Healthcare News

5 new deaths from liquid-filled intragastric balloons prompt FDA warning

The FDA today released a notice warning of five new patient deaths related to two liquid-filled intragastric balloon systems used to treat obesity, produced by Apollo Endosurgery (NSDQ:APEN) and ReShape Lifesciences (NSDQ:RSLS). The additional deaths bring the total number of deaths worldwide from the...

June 5, 2018

Imaging Visualization & Navigation

Mauna Kea Cellvizio Laser Receives Expanded Clearance for Neurological Procedures

Mauna Kea‘s (Paris, France) Cellvizio 100 series F400 and F800, with a new Confocal Miniprobe called CranioFle, has been granted FDA clearance to be used in neurological procedures targeting brain and spinal tumors. The confocal laser endomicroscopy system allows clinicians...

June 4, 2018

Diagnostics & Healthcare News

Layoffs at IBM Watson Health Spark Concerns

IBM has laid off approximately 50 to 70 percent of staff this week in its Watson Health division, according to inside sources. The axe, we’re told, is largely falling on IBMers within companies the IT goliath has taken over in...

May 31, 2018

Surgery and Surgical Robotics

FDA Approves First Artificial Iris

A German company has become the first to score FDA approval for a stand-alone prosthetic iris in the United States. The agency said Wednesday afternoon that it approved the CustomFlex Artificial Iris, made by Erlangen, Germany-based HumanOptics. The device, which is surgically...

May 31, 2018

Surgery and Surgical Robotics

TransEnterix Announces FDA Clearance for Expanded Indications for Senhance Surgical System

RESEARCH TRIANGLE PARK, N.C.–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced that the Company has received FDA 510(k) clearance for expanded indications...

May 29, 2018

Cardiovascular / Cardiology

Class I Recall Issued by FDA for Abbott’s HeartMate 3 Heart Pump

The FDA issued a Class I recall for Abbott’s HeartMate 3 left ventricular assist device due to possible twisting of the outflow graft that could result in a persistent low-flow alarm, which normally signals potential safety risks including low blood...

May 23, 2018

Diagnostics & Healthcare News

FDA Permits Marketing of First Autonomous Artificial Intelligence-Based Medical Device

On April 11, 2018, the U.S. Food and Drug Administration (“FDA”) permitted marketing of the first device to use artificial intelligence (“AI”) autonomously to detect a medical condition. The device, called IDx-DR, utilizes an AI algorithm to screen for diabetic...

May 23, 2018

Surgery and Surgical Robotics

Next Generation Stent Retriever Receives 510(k) Clearance

CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EMBOTRAP II Revascularization Device, a next generation stent retriever used to capture and remove...

May 22, 2018

Orthopedics and Spine

3D Printed Bone Segments for Foot and Ankle Fixation Receive 510(k) Clearance

Additive Orthopaedics, LLC., the leader in 3D printed orthopaedic foot and ankle devices, today announced that is has received FDA 510(k) clearance for its Patient Specific 3D Printed Bone Segments, to address internal bone fixation in the ankle and foot....

May 18, 2018