The U.S. FDA’s predetermined change control program (PCCP) is the talk of the med-tech town, but this novel regulatory mechanism has its limitations, said Cassie Scherer, senior director for digital health policy at Medtronic plc. Read More
Astrazeneca plc launched a health-tech business aimed at bringing to market digital technological solutions that will optimize clinical trial design and delivery. The company, called Evinova, will offer solutions to reduce the time and cost of developing new drugs, bring care closer to patients at home and reduce the burden on health systems. Read More
The U.S. FDA advises health care providers (HCPs) to avoid using Monoject syringes distributed by Cardinal Health with syringe pumps or patient-controlled analgesia (PCA) pumps because of incompatibilities between the Monoject interface and the pumps. Read More
South Korean researchers from the Gwangju Institute of Science and Technology (GIST) developed a new fluorescence-based lateral-flow immunoassay (LFI) enhanced with gold nanorod (GNR)-based probes to detect viral infections like the influenza A virus. Read More
Researchers from the University of Pittsburgh seek patent protection for a method of treating motor disorders by applying an electrical stimulus to neurons in the thalamus. The invention is based on their discovery that deep brain stimulation of specific lateral areas in the thalamus leads to improvements in motor outputs of voluntary movements affected by motor disorders. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Healwell, Implantica, Nanovibronix, Pixium, Pulse Biosciences. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medical, GE Healthcare, Medtronic, Pixyl, Supira Medical. Read More
