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Diagnostics & Healthcare News

Intuitive Acquires Orpheus Medical to Expand Informatics Platform for Hospitals

Intuitive, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced it has acquired privately held Orpheus Medical to deepen and expand its integrated informatics platform. Orpheus Medical provides hospitals with information technology connectivity, as...

February 11, 2020

Cardiovascular / Cardiology

FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer Inside-Out Access Catheter System

Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the U.S. Food and Drug Administration (FDA) has granted a De Novo classification order for its Surfacer® Inside-Out® Access Catheter System....

February 11, 2020

Surgery and Surgical Robotics

FDA Clears Paragonix Technologies’ LUNGguard for Donor Lung Preservation

Paragonix Technologies, Inc. today announced clearance of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Donor Lung Preservation System – LUNGguard1,2. The Paragonix LUNGguard Donor Lung Preservation System is intended to be used for the...

February 10, 2020

Orthopedics and Spine

In2Bones Receives FDA 510(k) Clearance for Quantum Total Ankle 

In2Bones Global, Inc. today announces clearance from the U.S. Food and Drug Administration to market the Quantum™ Total Ankle. This new total ankle replacement system treats patients who suffer from arthritis and is designed to improve patient mobility, increase stability, and...

February 6, 2020

Cardiovascular / Cardiology

Aria CV Receives FDA Breakthrough Designation for Its Medical Device for Treating Pulmonary Arterial Hypertension 

Aria CV, Inc., a developer of medical devices treating Pulmonary Arterial Hypertension (PAH), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Aria CV Pulmonary Hypertension System (Aria CV PH System). The...

February 6, 2020

Diagnostics & Healthcare News

Serenno Medical Introduces Novel Device for Continuous Automatic Monitoring of Kidney Function of Hospitalized Patients

Serenno Medical, developer of medical devices for patient monitoring in a hospital setting, reveals Sentinel™, a novel, robust device for automatic monitoring and detection of kidney damage in hospitalized patients. The Sentinel device is a continuous urine output monitor that measures...

February 5, 2020

Surgery and Surgical Robotics

LapTrainer Mixed Reality Simulator for Laparoscopy Training Unveiled

The long-term collaboration between KARL STORZ and VirtaMed in the domain of medical simulation reaches a milestone with the development of LapTrainer, a cutting-edge hybrid simulator designed to maximize the benefits of simulation in laparoscopy. The new simulator offers a unique...

February 4, 2020

Diagnostics & Healthcare News

Amid Coronavirus Outbreak, FDA and Industry Seek Roadmap for Emergency Diagnostics 

Just as some manufacturers hasten to make tests available for the novel Wuhan coronavirus, FDA will convene with industry representatives Monday in hopes of developing a better “roadmap” for how diagnostics are evaluated during and potentially after emergencies. The workshop...

February 3, 2020

Surgery and Surgical Robotics

BIONIK Laboratories Announces Regulatory Approval and First Sale of its InMotion ARM Robotic Technology by its Exclusive Distributor in South Korea

BIONIK Laboratories Corp., a robotics company focused on providing rehabilitation and assistive technology solutions to individuals with neurological and mobility challenges from hospital to home, today announced it has received regulatory approval in South Korea, and that its exclusive distributor...

January 30, 2020