After a deal between General Motors and Ventec Life Systems to produce 80,000 ventilators briefly appeared halted, President Trump yesterday ordered GM to proceed under the Defense Production Act. A New York Times report earlier on Friday said the Federal Emergency Management Agency had paused the $1 billion plan, saying it needed time to determine […]
Respiratory
AdvaMed: Invoking Defense Production Act could hinder U.S. medtech imports
Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic might actually hurt the U.S. supply of those items, the head of medtech trade group AdvaMed said today. AdvaMed officials have talked with U.S. secretary of Health and Human Services Alex Azar and FDA commissioner Dr. Stephen Hahn about medtech […]
GE Healthcare quadruples ventilator production at Wisconsin plant
General Electric Healthcare (NYSE:GE) this week announced that it is doubling its production capacity for ventilators and expanding its Madison, Wisconsin, production line to 24-hour operation. In a report on GE’s website, the company shared that it has doubled its capacity of ventilator production with plans to double it again by the end of the second […]
DeviceTalks Weekly: Ep. 3 – Deconstructing medtech’s alphabet soup – DPA, MDR, FDA are all in the news
In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry. Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less […]
Research collaboration to allow manufacturers to produce PPE
The Global Center for Medical Innovation (GCMI) announced this week that it is entering into a collaboration with multiple entities to address the shortage of personal protective equipment (PPE) during the coronavirus outbreak. Atlanta-based GCMI is collaborating with Dr. Joanna Newton, a pediatric hematologist/oncologist at the Aflac Cancer & Blood Disorders Center of Children’s Healthcare […]
FDA says it’s open to EUAs for ventilators to treat coronavirus
Amid a shortage of ventilators for treating coronavirus, the FDA put out a statement confirming its stance on issuing emergency use authorizations for potential temporary fixes. The FDA said it is operating on the basis of a EUA determination that the U.S. Dept. of Health and Human Services issues on Feb. 4. Earlier this week, […]
FDA to authorize certain imported respirators for healthcare worker use
The FDA said yesterday that certain imported respirators (FFRs) may be eligible for emergency use authorization (EUA) to protect public health and safety during the coronavirus outbreak. The FDA said these these devices, imported from Australia, Brazil, Europe, Japan, Korea and Mexico, may be effective in protecting healthcare workers from airborne COVID-19 particulates, “based on […]
Elon Musk says he delivered more than 1,000 ventilators to U.S.
Tesla co-founder & CEO Elon Musk confirmed on Twitter that he orchestrated the delivery of more than 1,000 ventilators to the U.S. California Governor Gavin Newsom initially announced last night that Musk delivered 1,000 ventilators to the state. After some back-and-forth discussion on the social media platform regarding where Musk got the devices, the entrepreneur […]
3M partners with Ford for coronavirus response
3M (NYSE:MMM) and Ford Motor Co. announced that they are entering into a partnership in an effort to increase the production of 3M’s PAPRs (powered air-purifying respirators) in response to the shortages caused by the coronavirus outbreak. The two companies plan to collaborate on specific means to rapidly combine each others’ capabilities and resources to meet […]
Zoll says it will make 10k ventilators a month
Zoll Medical Corp. announced that it is increasing its manufacturing capacity to 10,000 ventilators per month in response to the COVID-19 pandemic. Chelsmford, Mass.–based Zoll reached out to its supply base, which is mostly stationed in the U.S., to enlist its support as it ramps up its ventilator production nearly 25-fold compared to recent production […]
University of Minnesota researcher touts makeshift $150 ventilator to treat coronavirus
The University of Minnesota is touting makeshift ventilators made from $150 in parts as potential solutions amid the shortage of equipment at healthcare facilities during the COVID-19 outbreak. According to a report in the Star Tribune of Minneapolis, researchers tested the prototype on a pig, keeping the animal breathing for an hour and confirming the possibility of […]