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Cybersecurity Remains a Critical Consideration for Healthcare Industry
The number of attacks are rising, along with the associated costs.GlobalData 12.03.20
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Medigate, Arrow Electronics to Bolster IoT Device Security
Healthcare delivery organizations will have access to a medical device security platform known for its advanced cyber threat protection of clinical networks.Business Wire 10.30.20
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HSCC Publishes Supply Chain Cybersecurity Risk Management Toolkit
Provides guidance and tools to help organizations manage cybersecurity risks.The Healthcare and Public Health Sector Coordinating Council 09.22.20
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Electronics
Disruptive Medical Device Cybersecurity Solution
A new technology offers a different approach to cybersecurity for implantable devices.Online Exclusives Daniel L. Greene, Ph.D., COO, and James M. Hair III, Ph.D., CSO—Tueor Technologies 08.27.20
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R&D & Design
Medtech R&D Must Address Outcomes in Value-Based Care
Clinical requirements are no longer the only cornerstone of medical device development.Online Exclusives Michael Barbella, Managing Editor 04.24.20
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CENTOGENE Releases New Swab Product to Facilitate COVID-19 Diagnosis
The kit has a sterile package containing a swab and collection tube.Globe Newswire 04.24.20
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Diagnostics
FDA Clears Siemens Healthineers' Aidan AI
The latest technology enables new features and enhanced security.Siemens Healthineers 04.22.20
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Non-Traditional Thinking Can Help Drive Medtech R&D
Non-healthcare-related companies like Google, Amazon, and Apple can provide the medtech industry with unique solutions to age-old problems.Online Exclusives Michael Barbella, Managing Editor 04.21.20
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R&D & Design
Smaller Businesses Beget Better Innovation
Despite their global sales reach, large firms tend to focus on nurturing existing product lineups.Online Exclusives Michael Barbella, Managing Editor 04.16.20
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Digital Health
Viz.ai Adds Next-Generation Functionality to Artificial Intelligence Stroke Platform
New capabilities allow the stroke care team to synchronize care from stroke code notification to the post-acute care period.Business Wire 04.16.20
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Domestic Manufacturing of Medical Devices Trending Due to COVID-19
Ramping up domestic production capacity of medical supplies is the major focus for many countries as the pandemic spreads, according to GlobalData.GlobalData 04.14.20
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COVID-19 is Exposing the Fragility of Global Supply Chains
Pandemic likely will prompt healthcare companies to reshape supply chains to strengthen the risk management process and resilience.GlobalData 04.13.20
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Georgia Man Arrested in Multi-Million Dollar COVID-19 Scam
Suspect tried secure orders from the Department of Veterans Affairs for 125 million face masks and other PPE totaling more than $750 million.U.S. Department of Justice 04.13.20
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Software & IT
Seeking Software Partners During a Crisis
The COVID-19 pandemic has caught many unprepared to handle increased challenges, leaving them to find assistance.Online Exclusives Svetlana Anishchenko, Director of Marketing, Auriga Inc. 04.07.20
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Compliance with Medical Product Shortage Reporting Requirements During the COVID-19 Pandemic
A reminder of what manufacturers should keep in mind during this turbulent time.Online Exclusives Veleka Peeples-Dyer and Khelin Aiken, Baker McKenzie 04.02.20
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Diagnostics
PCR Biosystems Works to Ensure Availability of COVID-19 Test Reagents
Company has the capacity to manufacture enough reagent daily for 4 million reactions, which is sufficient for millions of diagnostic tests.PCR Biosystems 04.02.20
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R&D & Design
Examining the Usability of Medical Software
Developers need to consider the ‘human factor’ when it comes to testing medical device software.Bruce Johnston, Senior Software Engineering Specialist, MedAcuity Software 04.01.20
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Software & IT
Validating Your QMS the ‘EZ Way’
Securing approval for an eQMS solution is only the beginning; ensuring it’s properly installed and set up is arguably more significant.James Shore and Roxana Rosales 04.01.20
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Digital Health
Digital Defenders: COVID-19 Creates a Spotlight on Digital Health Tools
Digital health tools like telemedicine, AI algorithms, and connectivity are playing an increasingly important role in helping prevent and manage disease.Michael Barbella, Managing Editor 04.01.20
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Diagnostics
Gaining a Clearer Picture of Hitachi
Diagnostic imaging is gaining the attention of many in healthcare as the technologies shrink in size and become available to those outside the hospital.Sean Fenske, Editor-in-Chief 04.01.20
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The Economics of a Sound Regulatory Strategy
While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20
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COVID-19’s Lasting Impact on Healthcare’s Supply Chain
While some have speculated about what will happen after this passes, the one area that most interests me is the medical device and healthcare supply chains.Sean Fenske, Editor-in-Chief 04.01.20
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Diagnostics
FDA OKs Sectra's Digital Pathology Module
Available for primary diagnostics and remote reading in the U.S.PR Newswire 04.01.20
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Diagnostics
Siemens Healthineers’ RAPIDPoint 500e Blood Gas Analyzer Cleared
The analyzer is used to diagnose and monitor critically ill patients in the intensive care unit, operating room, or emergency room.Siemens Healthineers 03.31.20
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Trump Signs $2 Trillion Coronavirus Stimulus Package
Legislation requires the strategic national stockpile to include certain medical devices necessary for diagnosing and treating COVID-19.Staff and Wire reports 03.27.20
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Digital Health | Software & IT
FDA OKs Pear Therapeutics' Digital Therapy for Chronic Insomnia
Somryst delivers digital Cognitive Behavioral Therapy for insomnia.Business Wire 03.26.20
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Senators Introduce Bill to Address Medical Supply Vulnerabilities
Bill would study and develop action plan to address U.S. dependence on foreign-made medical equipment and boost domestic production and supply.Lamar Alexander (R-TN) and Dick Durbin (D-IL) 03.12.20
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U.S. Medtech Venture Financing Totaled Nearly $770 Million in December 2019
Deal total fell 9.1 percent that month.GlobalData 03.11.20
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Digital Health
Teamplay Digital Health Platform Launched by Siemens Healthineers
The teamplay digital health platform facilitates easy access to solutions for operational, clinical, and shared decision support.Siemens Healthineers 03.09.20
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R&D & Design
Four Considerations for Developers of Next-Generation Combination Products
Bringing together real-time monitoring, telemedicine, AI, interventions, and pharmaceuticals into a single device produces a number of potential pitfalls.Mark Goodman and Barry Thompson, Baker & McKenzie LLP 03.04.20
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Software & IT
FDA Warns of 'SweynTooth' Cybersecurity Risk in Certain Devices
SweynTooth affects Bluetooth Low Energy (BLE) wireless communication technology.U.S. Food and Drug Administration 03.04.20
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Medical Device Tax Repealed & Early 2020 Updates
Congress has also been active in the healthcare space, targeting efforts to lower the cost of prescription drugs and end surprise medical billing.Jeffrey J. Kimbell, David C. Rudloff and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 03.04.20
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Software & IT
GE Healthcare Launches Cybersecurity Service
Skeye helps identify risks and vulnerabilities, recommended action plans, remediation advice, and execution strategies.GE Reports 02.21.20
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Software & IT
Security for Connected Medical Devices
Why including the latest security protocols and technologies is an essential design task.Online Exclusives Alan Grau, VP of IoT/Embedded Solutions, Sectigo 02.18.20
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Cardiovascular
Abbott Wins EU Approval for Next-Gen Gallant ICDs, CRT-Ds
Smartphone app and Bluetooth connectivity helps doctors tailor therapy to a patient's clinical needs.Abbott Laboratories 02.18.20
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Diagnostics
FDA Authorizes Emergency Coronavirus Diagnostic Test
Authorization allows use of the test at any CDC-qualified lab across the country.U.S Food and Drug Administration 02.05.20
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Medigate, Cerner Partner on Medical Device Security
Influx of IoT medical devices raises importance of network security among healthcare organizations.Business Wire 02.05.20
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FDA Clears t:slim X2 Insulin Pump With Advanced Hybrid Closed-Loop Technology
Automated insulin dosing software is the first to receive new classification by the agency.Business Wire 02.03.20
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Abbott Labs Executive Joins McKesson as Chief Technology Officer
New hire will be in charge of the company's enterprise business technology strategy.Business Wire 01.30.20
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Industry Assessment: A Roundtable of Medtech Executives
Top medtech executives from across the industry weigh-in on a variety of issues impacting medical device manufacturers.Sean Fenske, Editor-in-Chief 01.29.20
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Electronics
Medtech Connects with Electronic Manufacturing Solutions
IoT, data collection, wearability, connectivity, and miniaturization lead as the demands medtech has of its electronics-centric suppliers.Mark Crawford, Contributing Writer 01.29.20
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Patient Monitoring
Security Risks Found in Some GE Healthcare Monitoring Devices
An attacker could remotely take control to silence alarms, generate false alarms, or interfere with the function.U.S. Food and Drug Administration 01.24.20
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GE Healthcare Launches Program to Ease AI Adoption for Medical Providers
Program provides deep technology integration in a secure platform; flexibly deploys in the cloud, at the edge or on device.Business Wire 01.21.20
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Mike on Medtech: Change Management, Part 2
Mike Drues and Sean Fenske discuss the potential implications for a medical device manufacturer who mishandles the reporting of a change to a device.Sean Fenske, Editor-in-Chief 01.20.20
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Mike on Medtech: Change Management, Part 1
Mike Drues and Sean Fenske discuss the procedures and best practices for handling change management for a variety of potential revisions to a device.Sean Fenske, Editor-in-Chief 01.20.20
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Digital Health
Zebra Medical Vision Partners With Nuance to Bring More AI to Diagnostic Imaging
Zebra-Med’s AI1 “all in one” bundle will be available on the Nuance AI Marketplace to support radiology functions.Business Wire 01.20.20
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HIPAA and Med Devices: Where the Crossroads Meet
Think HIPAA compliance is optional? Think again.Online Exclusives Chris Byers, CEO of Formstack 01.15.20
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Excelitas Technologies Introduces X-Cite Vitae vIR+ RGB Illumination System to Market
The X-Cite Vitae vIR+ can match any CCT with individual RGB control.Excelitas Technologies Corp. 01.14.20
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OmniVision Unveils Compact Medical Camera Module With Industry’s Fastest Frame Rate
Wafer-level module offers world’s most compact 640k resolution camera for disposable endoscopes.OmniVision Technologies Inc. 01.10.20
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NTT Research, German University Collaborating on Implantable Electrode Technology
Partnership expands NTT Research's footprint into Germany.Business Wire 01.06.20
