Cell Envision Ltd. completed an angel round that will help expand its presence in the U.S. and Europe. Taiwan-based Cell Envision has developed a self-assembled cell arrangement (SACA) monitoring system that can improve patient survival rates of cancer, together with enhancements in reproductive medicine.
Insulet Corp. got the U.S. FDA’s nod to extend use of its Omnipod 5 automated insulin pump to children aged 2 years and up with type 1 diabetes. The expanded indication, just seven months after FDA cleared Omnipod 5 for patients 6 years and older, represents the first time a tubeless automated insulin delivery (AID) system has been authorized for use in children this young.
The Charles Stark Draper Laboratory Inc. has joined forces with the U.S. Department of Defense (DoD) to screen pathogens, toxins and diseases using its high-throughput organ-chip devices. As part of a concerted effort to develop new medical countermeasures against biological and chemical threats, organs-on-a-chip provide directly applicable insights into human responses and enable testing on organs developed from a diverse pool of live donors prior to human trials.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lunit, Myriad Genetics.
Integra Lifesciences Holdings Corp., of Plainsboro, N.J., said in its latest 8K filing that it has decided to voluntarily remove all the company’s Cerelink systems – which are indicated for intracranial pressure monitoring – due to customer reports that these monitors were returning inaccurate pressure readings.
Xeltis BV raised $15 million in series D2 funding to develop its restorative vascular access device for patients with chronic kidney disease who are on hemodialysis. The investment in this technology, called the Axess graft, came from Hong Kong-based China Grand Pharmaceutical and Healthcare Holdings Ltd. (Grand Pharma). The deal focuses mainly on commercializing Axess, but also involves other new products in the field of hemodialysis developed as part of the Xeltis technology platform. The commitment from Grand Pharma includes equity investment and product licensing, representing Xeltis’ first commercial deal and its first funding from an Asian concern.