Neoprobe presses past controversy, submits Lymphoseek NDA| Regulatory Roundup

From Medical Design & Outsourcing

• 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… […]
• Boston researchers have created a potential N95 mask alternative
  Brigham & Women’s Hospital says it is developing a new, sustainable alternative to N95 respirator masks that are in demand during the COVID-19 pandemic. A team of bioengineers and clinical experts at the Boston-based hospital and the Massachusetts Institute of Technology (MIT) are working on the “injection molded autoclavable, scalable, conformable” iMASC system for providing… […]
• MIT researchers think they’ve found a way to get more particles through a syringe
  Researchers at the Massachusetts Institute of Technology (MIT) are touting a computational model that could prevent microparticle clogging during injections. Microparticles, which are about the size of a grain of sand, can be difficult to inject if they get clogged in a typical syringe. The research team at MIT developed this new model that determines… […]
• Fotofab adds direct-imaging machine for chemical etching
  Fotofab announced this week that it has acquired a new Chime Ball Technologies direct-imaging (DI) machine from Technica, USA to optimize its chemical etching process and provide a more advanced level of precision and speed for thin metal parts. The DI machine has CBT’s patented finger-print technology with LED lighting that enables Fotofab to directly… […]
• Could this heated air filter help fight COVID-19?
  University of Houston researchers and medical real estate development firm Medistar claim that they’ve designed an air filter that can catch and instantly kill the virus that causes COVID-19. Galveston National Laboratory tests on the filter found it killed 99.8% of SARS-CoV-2 virus in a single pass — as well as 99.9% of anthrax spores,… […]