Scientists are questioning the Trump administration’s claim for the effectiveness of convalescent plasma in preventing deaths from COVID-19, according to published reports. President Trump and the heads of the FDA and the Department of Health and Human Services all said on Sunday that plasma donated by former coronavirus patients has reduced deaths by 35%. Their… […]
“Factory of the future” systems can enable expanded and more versatile automation solutions, allowing device manufacturers to build their process steps, process speed and process cycles around the system’s capabilities. Bryant Boyd, Bosch Rexroth Medical device manufacturing processes tend to be highly regulated, requiring extensive documentation and rigorous quality control. They also need precise control,… […]
Thursday, September 24, 2020 11 a.m. Eastern time / 8 a.m. Pacific time Gaining the right product approvals and certificates for major markets is fundamental to both succeed and to ensure safety and effectiveness of every medical device. Properly defined and prepared submission reports contain the appropriate information required by the various regulatory… […]
Forward Industries (NSDQ:FORD) today announced the acquisition of substantially all of the assets of medical device design company Kablooe Design for $1.6 million in cash, equity, assumed debt and contingent earn-outs. Hauppauge, N.Y.-based Forward Industries is a technology product design company. Kablooe’s clients include Medtronic, Boston Scientific, Coloplast, Atricure, Cega Innovations and Rapid Diagnostek. “I am… […]
More than 600 lawsuits were filed last week against Sterigenics, claiming that emissions from the company’s now-shuttered Willowbrook, Ill., ethylene oxide (EtO) plant caused health problems in people who lived or worked nearby. The filings bring the total of personal-injury lawsuits against the Oak Park, Ill.-based company to more than 700, according to one of… […]
Testing is one of the key efforts to control COVID-19, and U.S. diagnostic test production capabilities are in demand. To respond to the pandemic with urgency, test developers need a highly flexible, scalable supply chain that can move quickly, control costs and manage quality. Claudio Hanna and Jennifer Ponti, Web Industries If COVID-19 has taught… […]
In this week’s episode of the DeviceTalks Weekly podcast, co-hosts Tom Salemi, editorial director of DeviceTalks, and Chris Newmarker, executive editor of life sciences, review this week’s Top 5 medtech stories, aka “Newmarker’s Newsmakers,” with news coming from CureVac, Avail Medsystems, ClearMask, Thermo Fisher and Bayer. We also hear from two executives from Fractyl Laboratories… […]
The latest earnings season not only provided insights from top medtech CEOs about how the COVID-19 pandemic is changing the industry, but also lessons learned going forward. Here are five top quotes about lessons learned. Next>> DeviceTalks editorial director Tom Salemi contributed to this report. The post The top 5 medtech CEO quotes about COVID-19 […]
Medical device manufacturers can produce high-performing, complex geometric parts and components for surgical instruments at high volumes cost-effectively using a metal injection molding (MIM) process. This flexible, hybrid technology can deliver high-quality parts consistently using a single manufacturing process. Steve Santoro, Micro Demand for lightweight, disposable surgical devices has been increasing as hospitals see a… […]
FDA will no longer require a premarket review of laboratory-developed tests during the COVID-19 pandemic, according to a decision announced on the U.S. Department of Health and Human Services website. Such a requirement in the future will need notice-and-comment rulemaking versus guidance documents, compliance manuals, website statements or other informal issuances, HHS said in the decision… […]
Medical device companies have increasingly outsourced prototyping over the past two decades. It doesn’t have to be that way. Dr. Elliot Fegelman & Benjamim Ko, Kaleidoscope Innovation Whether tinkering in the garage or at multi-specialty design/build shops, product developers have traditionally built their own pieces and prototypes. As machining capabilities have gained sophistication and capabilities,… […]
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August 25, 2020 at 10:35PM
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Feds' convalescent plasma claim questioned - Mass Device
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