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Diagnostics & Healthcare News

FDA Breaks Record for Medical Device Approvals in 2018

It’s an unprecedented time for innovation and regulation in medical devices. The Food and Drug Administration announced that 2018 was their most successful year in approving medical devices. 106 devices received the FDA’s marketing green light, breaking the record of...

January 30, 2019

Orthopedics and Spine

Medtronic Announces First U.S. Spine Patients Treated with Mazor X Stealth Robotic Surgical System

Medtronic today announced the first U.S. patients treated with the Mazor X Stealth Edition for spine surgery following its recent commercial launch. The Mazor X Stealth Edition offers a fully-integrated procedural solution for surgical planning, workflow, execution and confirmation. The...

January 28, 2019

Orthopedics and Spine

Zimmer Biomet Receives FDA Clearance for ROSA® Knee System for Robotically-Assisted Surgeries

Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® Knee System for robotically-assisted total knee replacement surgeries. ROSA Knee features 3D pre-operative planning tools and real-time, intraoperative data...

January 25, 2019

Orthopedics and Spine

Orchid Orthopedic Solutions Acquired by European Private Equity Firm

Nordic Capital Fund IX announced today that it has agreed to acquire a majority holding in Orchid Orthopedic Solutions, from Altor Fund III who will retain a significant minority holding in the company. Headquartered in Holt, Michigan, Orchid is a world...

January 23, 2019

Surgery and Surgical Robotics

Northwestern Memorial Hospital Performs First US Robotic Lung Volume Reduction Surgery

Northwestern Memorial Hospital is the first in the country to successfully complete robotic-assisted lung volume reduction surgery (LVRS) using the da Vinci Xi Surgical System® to remove diseased, emphysematous tissue within the lungs for the treatment of severe emphysema, a progressive form of...

January 21, 2019

Diagnostics & Healthcare News

1 in 3 GoFundMe Campaigns are for Medical Bills and That’s a Problem Says GoFundMe CEO

Scrolling through the GoFundMe website reveals seemingly an endless number of people who need help or community support. A common theme: the cost of health care. It didn’t start out this way. Back in 2010, when the crowdfunding website began,...

January 17, 2019

Surgery and Surgical Robotics

TransEnterix Wins FDA Clearance for Senhance Ultrasonic Instruments

TransEnterix, Inc., a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced the Company received FDA 510(k) clearance for its Senhance Ultrasonic System. “Advanced energy devices are used within a high percentage...

January 15, 2019

Orthopedics and Spine

OSSIO Receives 501(k) Clearance for Bio-Integrative Bone Pins

The FDA has granted 510(k) clearance to Ossio for its family of bio-integrative bone pins, which secure broken bones during the healing process while leaving no permanent hardware behind. The pins are made of a natural mineral fiber matrix that...

January 14, 2019

Surgery and Surgical Robotics

IRRAS’s Intracranial Bleeding Management Device Used on First U.S. Patient

IRRAS AB, a commercial-stage medical-technology company, today announced that the first patient in the United States was successfully treated with IRRAflow, the company’s initial product that offers an innovative, therapeutic approach to the fluid management of patients with intracranial bleeding. “The US is the largest market for intracranial procedures, and...

January 10, 2019