Australian regulators propose changes to IVD oversight plan

From Medical Design & Outsourcing

• 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… […]
• Spinal Elements’ cervical fixation system wins FDA nod
  Spine surgery technology developer Spinal Elements announced today that it received FDA clearance for its Sapphire X product for anterior cervical fixation. Sapphire X is comprised of integrated instrumentation and high-angulation screws designed to help surgeons perform a procedure while preserving the patient’s skeletal and muscle tissue. The instrumentation is designed to reduce procedural steps… […]
• How COVID-19 impacts FDA interactions with medical device manufacturers
  By Stewart Eisenhart, Emergo Group The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. Get the full story here at the Emergo Group’s blog. The opinions expressed… […]
• Switchback Medical adds ‘sandbox approach’ to device testing
  Contract manufacturer Switchback Medical (Maple Grove, Minn.) today announced that it has added a new division. Switchback BioSim Innovations offers functional dynamic biosimulator model development, cell culture services and physician training, according to the company. Biosimulator models use animal and human tissue to create functional models, such as a pumping heart with working valves to… […]
• Smith College team wins ventilator design challenge
  A team of Smith College engineering alumnae, staff and faculty has won the CoVent-19 Challenge to design a rapidly deployable ventilator to address shortages caused by the COVID-19 pandemic, particularly in developing countries. A dozen anesthesiology resident physicians from Massachusetts General Hospital kicked off the public challenge April 1, attracting 200 entries. The 30-person team… […]
• FDA gives certain device makers more time to add UDIs
  The FDA said today that it will grant manufacturers of Class 1 and unclassified medical devices and certain others more time to add unique device identifiers (UDIs) to their products. These companies will now have until Sept. 24, 2022 to comply with the agency’s UDI rule, including standard date formatting, labeling and Global Unique Device… […]