medical device guru

Surgery and Surgical Robotics

TransEnterix Receives FDA Clearance for First Machine Vision System in Robotic Surgery

TransEnterix, Inc., a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced the Company received 510(k) clearance for the Intelligent Surgical Unit (ISUTM) that enables machine vision capabilities...

March 19, 2020

Imaging Visualization & Navigation

FDA Clearance Brings RefleXion Closer to Expanding Cancer Treatment Market 

RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* to treat all stages of cancer today announced it has received marketing clearance from the U.S. Food & Drug Administration (FDA) for stereotactic body radiotherapy (SBRT), stereotactic radiosurgery...

March 18, 2020

Diagnostics & Healthcare News

Hologic’s Molecular Test for the Novel Coronavirus Receives FDA Emergency Use Authorization 

Hologic, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Company’s new Panther Fusion® SARS-CoV-2 assay, a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19 disease. Hospital, public health...

March 17, 2020

Diagnostics & Healthcare News

The Consult Station: Front-Line Detection and Triage to Contain the Spread of Covid-19 

H4D, a leading global telemedicine company, is joining the international effort to fight the global coronavirus pandemic. H4D is providing hospitals with a fast, efficient and reliable solution to improve patient flow management in the emergency department. The Consult Station®...

March 17, 2020

Surgery and Surgical Robotics

Endologix Announces FDA Approval of AFX Endovascular AAA System

Endologix, Inc. (Nasdaq: ELGX), developer and marketer of minimally invasive treatments for aortic disorders, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its next generation product, the AFX™ Endovascular AAA System, for the treatment of...

March 16, 2020

Cardiovascular / Cardiology

TriGUARD 3 Cerebral Embolic Protection Device Receives CE Mark for Use in Transcatheter Heart Procedures

Keystone Heart Ltd., a Venus Medtech Company, today announced European CE Mark for the TriGUARD 3™ Cerebral Embolic Protection (CEP) Device. The device is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during...

March 16, 2020

Imaging Visualization & Navigation

FDA Clears Fluidda’s Broncholab Platform for Use in Clinical Practice

The US Food and Drug Administration provided market clearance to Fluidda for its Broncholab platform. Broncholab provides a number of Functional Respiratory Imaging (FRI) parameters to physicians via an online platform to assist in diagnosing and monitoring of respiratory diseases....

March 12, 2020

Orthopedics and Spine

OSSIO Receives FDA 510(k) Clearance for OSSIOfiber Hammertoe Fixation System 

OSSIO, Inc., an orthopedic fixation company, today announced that its OSSIOfiber® Hammertoe Fixation System has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone...

March 12, 2020

Cardiovascular / Cardiology

CryoLife Receives CE Mark for E-vita OPEN NEO 

CryoLife, Inc., a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has received CE Mark for the E-vita Open NEO, a hybrid stent graft system for the treatment of aortic arch disease. Aortic arch disease...

March 12, 2020