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From Medical Design & Outsourcing

• Medtronic, Johnson & Johnson warn of hospital worker burnout headwind
  Medical device manufacturers are worried that the COVID-19 pandemic’s latest wave will make for a tougher recovery in elective procedures after Delta variant cases subside. Top officials from Medtronic (NYSE:MDT), Johnson & Johnson (NYSE:JNJ), NuVasive (NASDAQ: NUVA) and Zimmer Biomet Holdings (NYSE:ZBH) recently warned investors of the problem. The concern is that the highly contagious… […]
• Medline inks a strategic partnership with Arnot Health
  Medline announced that it has forged a $40 million prime vendor partnership with New York-based Arnot Health. As the system’s primary supplier, Medline will exclusively provide an extensive portfolio of medical supplies and services to three diverse healthcare campuses across the southern tier of New York, the company said yesterday. The two organizations will identify… […]
• GE warns of supply chain strain well into 2022
  Medical device makers and suppliers seeking relief from the global semiconductor shortage will have to hold on a while longer. GE (NYSE:GE) is warning investors that supply and labor shortages are squeezing its Healthcare business this quarter and that the pressure won’t likely let up in 2021. GE Healthcare’s business “largely is a supply chain… […]
• Theranos whistleblower testifies to blood analyzer inaccuracies in Elizabeth Holmes fraud trial
  One of Theranos’ whistleblowers testified on the inaccuracies in the blood analyzers that Theranos had touted to investors on the third day of Elizabeth Holmes’ federal fraud trial. Erika Cheung, a former Theranos lab associate, testified yesterday that the machines the company was using to conduct patient blood tests had inaccuracies of quality control test… […]
• CMS aborts launch of MCIT payment program for breakthrough devices
  CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs. CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar yesterday — three months before the rule was set to take effect… […]
• One of FDA’s top lawyers leaves to join Greenberg Traurig
  Greenberg Traurig recently announced that James C. Fraser, a former associate chief counsel for litigation at the FDA, has joined its Litigation and Health Care & FDA practices in Washington, D.C. Fraser left FDA in August. He has more than 16 years of experience in life sciences litigation and most recently worked in conjunction with… […]
• September 2021 Issue: Our latest Medical Device Handbook is out!
    Making medical devices: Everything you need to know The innovation-fueled evolution of drug eluting stents Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’ Getting the inside scoop behind top medtech innovations Autumn is upon us, and it is once again time to sip a pumpkin spice latte  — or a pumpkin beer —… […]
• Steris launches two new vaporized hydrogen peroxide biodecontamination systems
  Steris has launched the next generation of its vaporized hydrogen peroxide (VHP) biodecontamination systems to achieve 6-log bioburden reduction in good-manufacturing-practice pharmaceutical, medical device and research environments. It’s possible to integrate the new VHP 100i and 1000i systems into a facility’s building automation and HVAC systems, running a decontamination cycle at programmed intervals or at… […]
• First witnesses in Elizabeth Holmes federal fraud trial take the stand
  Two of the prosecution’s witnesses took the stand yesterday on the second day of Elizabeth Holmes’ federal fraud trial. Theranos’ former financial controller San Ho Spivey, who is referred to as Danise Yam, took the stand and testified about the company’s financial condition during its heyday. Yam told Assistant U.S. Attorney Robert Leach that Theranos… […]
• Axonics loses IP challenge to Medtronic patents
  Medtronic (NYSE:MDT) announced that it picked up three victories in an intellectual property (IP) dispute against Axonics (NSDQ:AXNX) over sacral neuromodulation devices. According to a news release, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) rejected Axonics’ attempt to invalidate three Medtronic patents in its IP infringement lawsuit related to Medtronic’s InterStim neuromodulation device… […]
• Cepheid wins EUA for new version of COVID-19, flu, RSV combination diagnostic
  Cepheid announced today that it received FDA emergency use authorization (EUA) for its Xpert Xpress CoV-2/Flu/RSV Plus diagnostic. Sunnyvale, California-based Cepheid designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV). Get the full story at our… […]