medical device guru

Orthopedics and Spine

FDA Clears First Nanotechnology PEEK Devices for Spinal Intervertebral Fusion

Vallum Corporation, a medical device company, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus® nanotextured surface created by Vallum’s proprietary and...

July 18, 2018

Diagnostics & Healthcare News

Biotech Manufacturing is Booming with Growth of Biologics and Gene Therapies

Manufacturing is the non-glamorous side of biopharma, although its impact on the economy shouldn’t be underestimated. For example, a recent report published by TEConomy and BIOtitled, “Investment, Innovation and Job Creation in a Growing U.S. Bioscience Industry 2018,” reported that the average wage in bioscience...

July 18, 2018

Surgery and Surgical Robotics

Novel Intracranial Fluid Management System Receives 510(k)

IRRAS AB, a commercial-stage medical technology company focused on developing and commercializing transformative treatments to manage intracranial fluids, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for IRRAflow, its integrated, closed medical device system that...

July 17, 2018

Surgery and Surgical Robotics

Digital Surgery’s AI Platform Will Guide Surgical Teams Through Complex Procedures

Digital Surgery, a health tech company shaping the future of surgery through the convergence of surgical expertise and technology, today announced it has developed and successfully demonstrated the world’s first real-time, dynamic artificial intelligence (AI) system designed for the operating...

July 16, 2018

Biologics, Wound Care, Infection Prevention

Innovative Bedside Biologic Maker RedDress Receives 510(k) for RD1 System

RedDress Ltd announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RD1 system. RD1 is an innovative wound care product which enables health care providers to produce in real time, in vitro whole...

July 16, 2018

Imaging Visualization & Navigation

First Ever Color X-Ray Performed on a Human

What if, instead of a black and white X-ray picture, a doctor of a cancer patient had access to colour images identifying the tissues being scanned? This colour X-ray imaging technique could produce clearer and more accurate pictures and help...

July 12, 2018

Biologics, Wound Care, Infection Prevention

Implantable Organ Developer Miromatrix Raises Additional $15.7M in Series B Funding

July 12, 2018 – Press Release by Miromatrix Medical Miromatrix Medical Inc. is excited to announce it recently raised $15.7 million in Series B-2 funding, surpassing its goal of $10 million. As part of the round, Miromatrix also welcomed its...

July 12, 2018

Surgery and Surgical Robotics

Onkos Surgical and Insight Medical Systems Team Up On an Augmented Reality Surgical System

Insight Medical Systems has teamed up with Onkos Surgical, Inc. to explore opportunities to apply Insight Medical’s ARVIS™ (Augmented Reality Visualization and Information System) in musculoskeletal oncology. The companies are working on a pilot project to assess the technology for use in tumor...

July 11, 2018

Imaging Visualization & Navigation

Imaging Group MITA Warns China Tariffs Will Cost $138M to US Imaging Industry

The Medical Imaging and Technology Alliance (MITA) – the leading organization and collective voice of medical imaging equipment, radiopharmaceutical manufacturers, innovators, and product developers – today called on the Trump Administration to establish a timely and robust exemption process for...

July 10, 2018