MITA Joins Coalition Urging Congress to Stop Provider Payment Cuts
The proposed PFS rule will lead to provider payment cuts for specialties that do not frequently bill E/M visits.
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AAMI Releases Complete Collection of Modern Dialysis Standards
AAMI is releasing Complete Dialysis Collection: 2020 edition, a comprehensive collection of 14 dialysis standards. New editions of the book will be regularly released to keep pace with the rapidly changing dialysis landscape.
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“Medical Device Servicing Safety and Accountability Act” Draws Mixed Opinions
On Tuesday, April 25, Congressmen Ryan Costello (R-Pa.) and Scott Peters (D-Calif.) introduced H.R. 2118, “Ensuring Patient Safety through Accountable Medical Device Servicing”—legislation that has garnered mixed reviews from members of the HTM community. Read about it here.
Nuvolo Joins AAMI as a Corporate Member
“The membership in AAMI fits squarely into Nuvolo’s commitment to empower customers with an HTM solution that improves governance of their medical devices, improves safety, and ensures compliance with regulatory standards,” says Tom Stanford, CEO of Nuvolo.
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Healthcare Coalition Launches COVID-19 Decision Support Dashboard
This free, web-based tool synthesizes large amounts of complex, essential data into easy-to-use key findings for public and private-sector leaders navigating the “reopening” of communities and businesses.
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AdvaMed Co-Issues “Re-entry Guidance for Health Care Facilities and Medical Device Representatives”
As healthcare professionals and organizations consider when and how to safely resume elective surgeries paused during the COVID-19 pandemic, this guidance adds principles and considerations to support the vital collaboration between healthcare personnel and medical device representatives.
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AdvaMed Issues MedTech Compliance Guidance for COVID-19 Response
The Advanced Medical Technology Association (AdvaMed) has announced the availability of a newly created “Code of Ethics Compliance Guidance Related to the COVID-19 Response.”
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U.S. Arms Makers and Medical Device Firms Team Up to Make Ventilators
When a defense industry consultant with an engineering background realized weapons makers could help solve supply-chain problems within the U.S. ventilator industry, the creation of Vent Connect was set in motion.
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Green Method Could Enable Hospitals to Produce Hydrogen Peroxide in House
An environmentally friendly method of producing hydrogen peroxide could enable hospitals to make their own supply of the disinfectant on demand and at lower cost.
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MedTech Industry Urges Additional Tariff Relief to Combat COVID-19
The Advanced Medical Association (AdvaMed) has requested that the U.S. Trade Representative provide additional tariff exclusions for medical devices, components, and supplies coming from China needed in the fight against the COVID-19 pandemic.
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IMDRF Finalizes Guidances on Cybersecurity, Personalized Devices, and Conformity Assessment Bodies
The International Medical Device Regulators Forum (IMDRF) has finalized technical documents offering guidance on cybersecurity, personalized devices, and conformity assessment bodies.
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FDA Lifts Injunction on Manufacture and Distribution of Philips’ Defibrillators
Philips has resumed the manufacturing and shipping of external defibrillators for the United States, following FDA notification that the injunction prohibiting those activities has been lifted.
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FDA Issues Final Guidance for Fetal and Maternal Monitoring Devices Used during COVID-10 Crisis
Modified use of these devices may increase access to important prenatal data without the need for in-clinic visits.
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Unique System for Using UVC Light to Sterilize Masks in Bulk Developed at Rensselaer
This project began at the request of longtime research partners at Mount Sinai. As the pandemic worsened in New York City, and the shortage of PPE deepened, they asked if Rensselaer could develop a way to make critical resources last longer without losing their effectiveness.
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Advocates Use COVID-19 to Push for ‘Right to Repair’ Legislation
Pennsylvania state legislators have introduced a bill that would require medical equipment manufacturers to give hospitals the information they need to fix the devices on their own.
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