Medical Innovation Exchange

Inga Hansen

Bridging Communication Gaps

Bridging Communication Gaps     Supply chain challenges arising from the Covid pandemic and exacerbated by war and workforce shortages are changing the way medtech companies source suppliers. Key to obtaining the correct materials and developing redundancy in your supply chain is maintaining good communication between your engineering, design and procurement teams. We spoke with George …

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Swiss National Council Votes To Accept FDA Approved Medical Devices

Swiss National Council Votes To Accept FDA Approved Medical Devices     On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to accept medical devices with FDA approval. Since 2001, healthcare providers and patients in Switzerland have only had access to medical devices with an EU certificate. Swiss MedTech, …

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WHO Convenes Panel to Identify Priority Pathogens for Research and Oversight 

WHO Convenes Panel to Identify Priority Pathogens for Research and Oversight      The World Health Organization (WHO) announced that it is launching a global scientific process to update the list of priority pathogens to guide global investment, research and development of vaccines, tests and treatments. The process began on November 18 with a meeting of …

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Baxter Recalls WatchCare IMS Due to Risk of Interference with Nearby Medical Equipment 

Baxter Recalls WatchCare IMS Due to Risk of Interference with Nearby Medical Equipment      Baxter Hillrom is recalling its WatchCare Incontinence Management System (IMS) following reports that the radiofrequency emissions (RF) from WatchCare devices may interfere with other medical devices. The U.S. FDA has identified this as a Class I recall, the most serious type …

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How Health Tech Can Combat the High Cost of Lifestyle Choices

How Health Tech Can Combat the High Cost of Lifestyle Choices     Lifestyle choices can be costly to patients, their insurance companies and to the American healthcare system in general. For instance, obesity-related healthcare costs top $190 billion each year, while inactivity adds another $117 billion to our annual bill. Even things we generally take …

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Tufts Neurosurgeons Honored for Innovation in Hydrocephalus Treatment

Tufts Neurosurgeons Honored for Innovation in Hydrocephalus Treatment     The Society of Vascular and Interventional Neurology (SVIN) has awarded Tufts Medical Center neurosurgeons Adel Malek, M.D., Ph.D., chief of neurovascular surgery, and Carl Heilman, M.D., neurosurgeon-in-chief and chairman of neurosurgery, the 2022 Innovation Award for their work to bring a minimally invasive, endovascular treatment to …

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From Art to Science:  How Machine Learning Is Changing the Surgical Landscape

From Art to Science:  How Machine Learning Is Changing the Surgical Landscape     Robotic surgery has already proven its value in improving surgical outcomes. The next frontier is using data collection and artificial intelligence to help guide surgeons in the OR and develop surgical simulators that can expand and enhance training opportunities. We spoke with …

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Theranos Founder Sentenced to 11 Years in Prison

Theranos Founder Sentenced to 11 Years in Prison     November 18, San Jose, CA: Theranos founder Elizabeth Holmes has been sentenced to 135 months (11.25 years) in prison by U.S. District Judge Edward Davila. Holmes, who was found guilty in January on three counts of investor fraud and one count of conspiracy to commit fraud …

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FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions

FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions     The FDA has issued the final guidance: Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents.  The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” …

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Why Human Factors Engineering Matters in Medical Device Packaging

Why Human Factors Engineering Matters in Medical Device Packaging     Human Factors Engineering (HFE), also referred to as Usability Engineering (UE), is the application of knowledge about human behavior, abilities, limitations and other characteristics of medical device users that are applied to the design of medical devices. These characteristics include mechanical and software-driven user interfaces, …

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