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Canon Medical Offers New Liver Reporting Tool for Ultrasound

To help easily and accurately determine cut off values, Canon Medical Systems USA, Inc.’s premium AplioTM i-series ultrasound platform is now available with software to display the calculated measurement averages from multiple samples of the liver, customizable based on the “Rule of Four.”

Rithem Life Sciences Joins Innovators’ Network at American Heart Association Center for Health Technology & Innovation

The Center is focused on building and fostering health technology relationships to develop innovative and scalable solutions.

1st Patients Enrolled in STEM Trial for `Treatment of Chronic Subdural Hematoma

This marks the first patients enrolled in a prospective, randomized, international trial of a liquid embolic agent for the treatment of chronic subdural hematoma (cSDH), a common disease affecting primarily older adults.

Genius AI Detection Receives FDA Clearance – New Deep Learning-based Software Designed to Help Radiologists Detect Subtle Potential Cancers in Breast Tomosynthesis Images

This new technology, represents a pivotal milestone in the early detection of breast cancer, as studies showed Genius AI Detection software aids in the identification and early detection of breast cancer when used with the Genius® 3D Mammography™ exam.

Passio Pump Drainage System Granted 510(k) for Additional Indication for Home Use

The Passio Pump Drainage System consists of the Passio Catheter, a Handheld Control Unit (pump) and a Disposable Collection Kit, which includes a redressing kit, for drainage of recurrent and symptomatic pleural effusion.

Michael Derby Is Appointed Technical Director, Regulatory Approvals at Element Materials Technology

September 1, 2020

Michael Derby has been appointed technical director, regulatory approvals at Element Materials Technology.

Michael Derby served as Director for ACB Europe as well as a senior reviewer for the certification of wireless devices. In this role, he acted as a Telecommunication Certification Body for the Federal Communications Commission (US), a Certification Body for Innovation, Science and Economic Development (Canada), as well as a Notified Body for the European radio equipment directive. In addition to the 13 years spent in product certification and regulatory approval, his career includes 16 years working in commercial test laboratories, with 10 years in the UK and six years in California, US. Michael is one of the world’s leading experts on the integration of wireless modules into host equipment and lead author in both US and European guidance on the subject.

Steve Hayes, Technical Director, Connected Technologies at Element, commented: “We are delighted to add Michael’s industry-leading technical expertise to our rapidly expanding Connected Technologies team. His prolific experience and proven track record as a leading voice in the sector, as well as his profile as a world-renowned expert in the field, will prove invaluable to our ambitious growth strategy.”

Michael Derby added: “I am excited to be taking on the role of supporting Element’s highly knowledgeable team of engaged experts, many of whom not only hold wireless testing and consumer product compliance expertise but also sit on industry working groups and committees. I am looking forward to guiding Element’s team of specialists as they continue to play a first-hand role in the development of the standards we test to.”

Michael started his UK-based role at Element on 1 September and will be responsible for supporting global projects and customers, reporting to Steve Hayes, Element’s Group-wide Connected Technologies Technical Director. He will work closely with teams across Element’s global network of Connected Technology related laboratories and offices.

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Face Shield Market Is Estimated to Grow Globally from USD 3.0 billion in 2020 to USD 4.1 Bil by 2025, at a CAGR of 65%

Face shield market size is estimated to grow globally from USD 3.0 billion in 2020 to USD 4.1 billion by 2025, at a CAGR of 6.5%.

Acquisition of Moldworx, LLC by Sunningdale Tech Ltd Completed Effective November 6, 2020

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1st PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer Receives FDA Approval

"Ga 68 PSMA-11 is an important tool that can aid health care providers in assessing prostate cancer," said Alex Gorovets, M.D., acting deputy director of the Office of Specialty Medicine in FDA's Center for Drug Evaluation and Research. "With this first approval of a PSMA-targeted PET imaging drug for men with prostate cancer, providers now have a new imaging approach to detect whether or not the cancer has spread to other parts of the body."

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