FDA clears St. Jude’s Amplatzer catheter-based vascular plug | Regulatory Roundup

From Medical Design & Outsourcing

• How Boston Scientific is managing labor shortages with cobots and Spanish
  Boston Scientific (NYSE: BSX) executives said two labor-shortage strategies are paying off in a big way for the medical device maker, which has around 41,000 employees across the globe. Collaborative robotics and Spanish-speaking shifts are helping Boston Scientific deal with a global labor shortage that’s been especially acute in the U.S. That’s according to Global… […]
• 6 power management considerations for developing and scaling smaller, smarter micromedical devices
  Supercharge every phase of micromedical device product development with these questions. Mitch Johnson, Intricon Some of the biggest considerations for designing, manufacturing and scaling today’s smaller, smarter medical innovations center on providing power to microelectronic systems. From mechanical functionality to data operations and wireless communications, effective power management drives continued device innovation. Addressing five fundamental… […]
• Evonik, Coopmed agree on wound dressing distro deal
  Evonik announced today that it signed an agreement for medical technology company Coopmed to distribute the epicite wound dressing. Jena, Germany-based Evonik said Coopmed will distribute the epicite dressing made from biosynthetic cellulose exclusively to the German market for chronic wound care. Epicite represents part of the portfolio from JeNaCell, which Evonik acquired in 2021.… […]
• Spartech hires Bosch VP Dan Gallo as chief operating officer
  Spartech today said it hired Dan Gallo as chief operating officer of the engineered thermoplastics and custom packaging manufacturer. Gallo started this month, according to his LinkedIn page. His career leading operations, supply chain and logistics functions spans more than three decades. He was most recently an operations VP at Robert Bosch. Before his time… […]
• 3M launches Verify platform to spot counterfeit products
  3M (NYSE:MMM) announced today that it established a new 3M Verify platform to report potential counterfeit 3M products. The effort builds upon its anti-counterfeit efforts during the height of the COVID-19 pandemic. At the time, a number of sellers claimed to offer 3M respirators. Instead, many offered fake, defective and damaged N95 masks at inflated… […]
• FDA will review fewer COVID-19 test EUA submissions
  The FDA is pushing COVID-19 test developers away from emergency use authorization (EUA) submissions in favor of more traditional pathways, the agency said today. The FDA said it intends to review “only a small subset” of new EUA submissions, encouraging test makers to seek regulatory approval through de novo classification or 510(k) clearance pre-market review… […]
• Integra plans to shrink the C-suite after executive’s exit
  Integra Lifesciences (Nasdaq: IART) will eliminate the position of chief operating officer next week — though the office is already empty. Former COO Glenn Coleman’s last day at Integra was Friday, according to a separation agreement filed with the Securities and Exchange Commission that same day. Coleman was scheduled to start as the new EVP and… […]
• Steris plans to build a new medical device testing facility
  Steris (NYSE: STE) plans to build a new packaging and microbiological testing facility for medical devices in Leipzig, Germany. The facility will offer packaging testing services such as accelerated and real-time aging, transportation and integrity testing. The new location will also offer microbiological testing in collaboration with the medical device manufacturer and sterilizer’s laboratory in… […]
• 10 medical device startups you need to know
  Some of the most interesting medical device startups of 2022 are advancing a wide range of innovative medtech: robotics, catheter-delivered brain-computer interfaces and more. The editors here at Medical Design & Outsourcing and MassDevice are writing about medical device startups all the time. But there are some device companies starting out that have technologies that… […]
• Steris stock downgraded as analysts expect lawyers to seek more ethylene oxide lawsuits
  Steris (NYSE: STE) stock was downgraded today by Needham from buy to hold following the $363 million jury verdict against its primary competitor, Sterigenics, over ethylene oxide (EtO) emissions. Needham analysts said they expect attorneys to target communities near EtO facilities with ads to find people willing to file more lawsuits against sterilization plant operators… […]
• Researchers develop at-home device to track Parkinson’s progression
  Researchers at MIT and the University of Rochester Medical Center have developed a device to monitor a Parkinson’s patient at home. Collecting data at home could help provide a less subjective measurement than evaluations at the doctor’s office, which can be affected by outside factors. The technology could also help pharmaceutical and biotech companies developing… […]