January 25, 2022
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Top Story
The Ycogni model, a machine learning-enabled predictive computer program that uses data from wearable devices to detect individuals at risk for depression, has been developed by researchers from Nanyang Technological University in Singapore.
Full Story: MobiHealthNews (1/24) 
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Modernizing Regulatory Affairs: Industry Benchmark Study Findings
Only 31% of medtech companies surveyed have a global RIM system in place, with manual processes still present in most areas. Access full report to see how you compare.
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Business & Market Trends
Royal Philips generated $5.5 billion in sales and $183 million in profits during its fiscal fourth quarter, which ended Dec. 31. "[S]ales were impacted by several headwinds, namely supply chain challenges, postponement of equipment installations in hospitals related to COVID-19, and the consequences of the Respironics field action," said CEO Frans van Houten.
Full Story: MassDevice (Boston) (1/24) 
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Manisha Shah-Bugaj has been chosen to serve as chief operating officer of Activ Surgical. Shah-Bugaj has previously served as global general manager and vice president of gynecology at Olympus.
Full Story: MassDevice (Boston) (1/24) 
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Fresh Look with Medical Design & Outsourcing
MIT team working on all-in-one diabetes management devices
MIT team working on all-in-one diabetes management devices
The platform estimates carbohydrate content of meals and then automates the process of pricking skin, collecting blood, calculating glucose levels and injecting the right amount of insulin. Read more.
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A primer on advanced recycling
How it works, how it can help reduce plastic waste from landfills, and our plans to scale it up. Read our newsletter.
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Science & Health
Private insurers have begun covering the cost of at-home COVID-19 tests for their members under a Biden administration plan; however, the administration's rule does not apply to Medicare beneficiaries. Medicare patients can look for testing options at community facilities and on the new COVIDtests.gov website.
Full Story: National Public Radio (1/24) 
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Emerging Technologies
Researchers from the University of Washington have developed the Harmony COVID-19 test, which can deliver results within 20 minutes. Initial results show the test has 97% effectiveness.
Full Story: KCPQ-TV (Seattle) (1/24) 
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Government & Regulatory
The FDA has given breakthrough status designation to Cook Medical for its drug-eluting stent for below the knee. The stent is used to treat patients with chronic limb-threatening ischemia.
Full Story: Medical Tubing + Extrusion (1/24) 
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The FDA has given emergency use authorization to Mammoth Biosciences for its DETECTR Boost SARS-CoV-2 Reagent Kit, a high-throughput CRISPR-based SARS-CoV-2 test. "This emergency use authorization is another important step towards our mission to harness the full potential of CRISPR to improve lives," said chief technology officer and cofounder Janice Chen.
Full Story: 360Dx (tiered subscription model) (1/24) 
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An emergency use authorization application has been submitted by Applied DNA to the FDA for its Linea 2.0 COVID-19 Assay and Linea Unsupervised At-Home Sample Collection Kit. "We believe this EUA request positions us to service existing demand for enterprise-scale Covid-19 testing with a compelling selling proposition where remote work is not a scalable option and a dependence on less sensitive, antigen-based tests can potentially lead to outbreaks and interruptions in business continuity," said President and CEO James Hayward.
Full Story: Medical Device Network (UK) (1/24) 
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Seegene's Allplex SARS CoV-2 FluA/FluB/RSV assay has received emergency authorization from Health Canada.
Full Story: FDAnews (1/25) 
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AdvaMed Events and Education
510(k) and De Novo Submissions Workshop: February 8-10, 2022
IDE Submissions Workshop: February 15-16, 2022
PMA Submissions Workshop: March 1-3, 2022

Register for the AdvaMed Medical Device Submissions Workshops! These interactive, online workshops include experts from FDA and industry to guide you through the critical steps in the 510(k), De Novo, IDE and PMA medical device submissions processes. AdvaMed members with three or more registrants can save an additional 10% off the AdvaMed member rate by using the code GROUP10. Learn more.
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Coverage, Coding and Reimbursement 101 Workshop: March 22-23, 2022
Coverage, Coding and Reimbursement 201 Workshop: April 26-27, 2022

Learn the basic principles of how medical technologies are covered and paid by insurers, the challenges medtech companies face in getting their technologies covered and paid, and strategies companies can use for achieving positive outcomes both for coverage and appropriate reimbursement for their products. The primary focus of the Reimbursement 101 and 201 Workshops will be the Medicare program's rules and processes for coverage and payment, but these seminars will also touch on private insurers' requirements as well. The 101 Workshop will cover the basics of Medicare's rules, and the 201 Workshop will cover broader topics, such as developing evidence for coverage and payment and managing a technology through a value as opposed to a volume paradigm. Sign up to receive updates.
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