Calgary Scientific’s iPhone app receives FDA clearance | Regulatory Roundup

From Medical Design & Outsourcing

• 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,… […]
• How Oscor makes a wide range of medtech
  Oscor boasts capabilities to design, develop, manufacture and market a wide range of medical devices, plus implantable-grade components and delivery systems. The Palm Harbor, Fla.–based company has four U.S. facilities with over 100,000 ft2  of engineering and cleanroom manufacturing space, plus two Dominican Republic facilities with another 120,000 ft2 and sales and warehouse facilities in… […]
• IluminOss lands expanded FDA clearance for fracture repair tech
  IlluminOss Medical recently announced that it received FDA 510(k) clearance for expanded use of its Photodynamic Bone Stabilization System. The system is designed to treat fractures in the pelvis, clavicle and small bones of the hands and feet. It is a minimally invasive approach for fracture repair and stabilization in a patient-specific intramedullary implant. “The… […]
• What is paratubing?
  Paratubing is a form of tubing that is made from two or more round tubes that are conjoined during extrusion. Paratubing, also called parallel tubing, comes in a wide range of thermoplastics and designs with electrical properties and signal carrying capabilities. The tubes are produced as multiple single lumen PVC tubes that are longitudinally joined […]
• CVRx CEO details the path from being engineer to medtech executive
  This week, CVRX reported positive six-month trial results for its Barostim Neo, an FDA-approved treatment for heart failure. The results follow years of close work between the agency and CVRx, one of the more ambitious startups in medtech. CVRx is targeting a huge clinical need with novel neuromodulation technology. In this week’s DeviceTalks Weekly podcast,… […]