FDA panel OKs Dune Medical’s MarginProbe breast cancer detection tool

From Medical Design & Outsourcing

• 3M, MIT working on paper-based, rapid COVID-19 test
  3M (NYSE:MMM) announced today that it is working with Massachusetts Institute of Technology (MIT) researchers to develop a paper-based, rapid test to detect the virus that causes COVID-19, with the potential to manufacture millions of tests per day. The test would detect viral antigens and deliver “highly accurate results within minutes” via a paper-based device, according… […]
• How to make amazing medtech hires
  It begins with an open mind and asking the right questions, and it ends with honesty and putting your best foot forward. John Compton, Agile Search Although the economic environment has no doubt changed the way you make strategic decisions, hiring the top talent within your sector will always be a competitive advantage. Your goal… […]
• Siemens Healthineers, DHL Supply Chain to create distribution facility in Memphis
  Siemens Healthineers (ETR: SHL) and DHL Supply Chain announced today that they have inked a comprehensive U.S. service logistics agreement. The agreement includes the two companies creating a 260,000 ft2 distribution center that DHL will operate in Memphis, Tenn. Under a 10-year service agreement, the Siemens Healthineers distribution operation will occupy more than half of a 422,000… […]
• Diagnostic imaging plus additive manufacturing yields custom implants
  Combining diagnostic imaging technologies with the design freedom of additive manufacturing has opened up new opportunities in prosthetics, enabling custom patient devices and improving the effectiveness of diagnosis, planning, surgery and clinical outcomes. Surgeons mainly use custom implants when bone geometry is not within the dimensional range of standard implants, when there are special requirements… […]
• CVRx CEO Nadim Yared suggests steps toward improving diversity and equality
  In this week’s episode of DeviceTalks Weekly, we follow up with last week’s guest, Nadim Yared, CEO of CVRx, to catch up on how the medtech executive is managing during the pandemic. Yared also shares some far-reaching views on what the medtech industry needs to work toward to improve diversity in its workforce and provide… […]
• Ogura Industrial touts holding brakes for robotic and medical equipment
  As automation continues to accelerate, there’s a growing need to hold equipment in place in the case of a power failure — or to provide positioning, according to Ogura Industrial, maker of six different styles of holding brakes. With roughly 120 standard models, key features of Ogura Industrial’s holding brake families include brake diameters down… […]
• What kinds of COVID-19 tests are out there?
  Months into the pandemic, the FDA continues to grant emergency use approval (EUA) to new tests to detect the virus that causes COVID-19 and the antibodies that indicate a person has had it. To date, the FDA has granted EUAs for 171 tests —142 molecular tests, 27 antibody tests, and 2 antigen tests. Given the ever-changing… […]
• FDA plans to resume onsite inspections later this month
  FDA has a goal of restarting on-site inspections during the week of July 20 — four months after it temporarily halted them — though there will be changes due to the COVID-19 pandemic. The agency today said that it will pre-announce inspections to FDA-regulated businesses. Said FDA: “This will help assure the safety of the… […]
• Formlabs announces new biocompatible, medical-grade resins
  Formlabs, the Somerville, Mass.–based maker of 3D printers, recently announced six new materials across its Form 3, Form 3B, and Form 2 SLA 3D printers — including two new biocompatible, medical-grade resins. The new material families and resins are meant to provide more options for designers and engineers in fields including: Healthcare — with a… […]
• Magnolia Medical launches Steripath Gen2 with integrated syringe
  Magnolia Medical this week said it launched its Steripath Gen2 Initial Specimen Diversion Device with an integrated syringe. The device is designed for reducing blood culture contamination in “hard stick” patients and syringe collection protocols. Steripath Gen2 features an integrated syringe that addresses difficult intravenous access. It offers precise control to carefully collect blood samples.… […]
• How Frankenstein sparked Earl Bakken’s love of medical devices
  When the late Medtronic founder Earl Bakken first watched the classic horror movie “Frankenstein” in the 1930s, it did more than just scare: It inspired. “What intrigued me the most as I sat through the movie again and again, was the creative spark of Dr. Frankenstein’s electricity,” Bakken said in his 1990 autobiography “One Man’s… […]