Mauna Kea lands 510(k), CE Mark for next-gen Cellvizio platform

From Medical Design & Outsourcing

• 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,… […]
• What’s next for nitinol tubing?
  Nitinol’s unique properties have made it the darling of the medical device industry. A novel technique for mechanically joining nitinol to other metal tubing could reduce cost and mitigate risk. Mark Broadley, Viant Nitinol has revolutionized the medical device industry. With its flexible superelasticity, shape memory and biocompatibility, nitinol has become a go-to material for… […]
• Report: Haemonetics’ blood-collection devices could leave particles in donors
  A consortium of news outlets is questioning the safety of Haemonetics (NYSE:HAE) blood-collection devices, claiming that particles have been detected in donors whose plasma was extracted by the machines. According to a report in the Miami Herald, whistleblower documents indicate that more than 150 Haemonetics customer reports have been made regarding the presence of particles by plasma collection centers and heathcare… […]