Manufacturing news briefs – stories you might have missed

FDA accepts Mesoblast’s responses  Biotech company Mesoblast has announced that the United States Food and Drug Administration (FDA) has accepted Mesoblast’s Biologics License Application (BLA) resubmission for Ryoncil (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). According to a statement, the FDA considers the resubmission to be a complete…

EMVision reveals first responder stroke scanner

Brain imaging company EMVision Medical Devices has completed fabrication of the company’s First Responder (Gen 2) Proof of Concept device (pictured). The First Responder device represents an opportunity to fundamentally transform stroke and traumatic brain injury outcomes for patients by delivering neurodiagnostic technology directly to the point of care, including in ambulances, according to the…

Why the $11 billion Australian medtech sector’s supply chain is at risk of another “COVID” shock

The medtech sector needs further investment in manufacturing to protect against further potential global shocks as medical supply chains in Australia have not recovered fully from the COVID-19 pandemic which caused havoc with patient care. By Dr Jack Richards.  In the face of threats like pandemics and shifting economic and geopolitical conditions, it’s imperative that…

Concussion-detecting headset maker eyes US market

Medtech business Headsafe has commercialised Nurochek, a portable headset for concussion screening which it calls its “brain scanner in a briefcase”, and which has been approved for sale in the United States. According to a statement from Headsafe and the Advanced Manufacturing Growth Centre – which supported development of Nurochek through a $447,500 Commercialisation Fund…

Optiscan launches InVue device for on the spot pathology results

Microscopic imaging technology company Optiscan Imaging has revealed an innovative new medical imaging device, InVue, which is designed to enable precision surgery through real-time digital pathology. Manufactured in Melbourne in partnership with industrial design firm Design + Industry, InVue is a significant milestone for the company, traditionally known for its confocal microscope devices. Optiscan CEO…