Australia’s Therapeutic Goods Administration has made a few adjustments to its advertising guidelines for social media promotions, including the requirement that the manufacturer is responsible for anything posted by influencers who are acting on behalf of the manufacturer.
Magstim Co. Ltd. reported that the U.S. FDA cleared its Magstim Rapid magnetic stimulation system for the treatment of chronic pain. The clearance provides a clinically validated therapy that directly targets neural pathways involved in pain processing to deliver a non-invasive, drug-free treatment for chronic pain.
One of the problems of doing business in the EU is that each member nation has its own more or less unique requirements for clinical trial registration, but the Medical Device Coordination Group may have a solution in the form of a pilot program for harmonized clinical trial registration.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aplitude Medical Systems, Cardiofocus, Flatiron, Microbix Biosystems, Natera, Neuronetics, Owlet, Rhapsody, Sanara, Sekisui Diagnostics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Augmedics, Hologic, Integra, Meduloc, Thermo Fisher Scientific, Welcony.
The U.K. government has published a road map for phasing out animal testing in life sciences research and announced £75 million (US$98.6 million) for work to develop nonanimal models, leaving scientists concerned because they say, in many cases, there can never be meaningful alternatives to using live animals.
At first glance, the results of the CLOSURE-AF study would seem to spell doom for left atrial appendage closure devices for patients at risk of stroke, but there is some noise in the signal, including that the devices used in the study no longer represent the state of the med-tech art.