Med-tech veterans advised companies looking to launch new products in fields with dominant players to mind their 'Ps and Qs,' but not the ones your mother drilled in childhood. Rather than good manners, they urged competitors attending Device Talks Minnesota to ensure they had the right people, product, proof, pace and quality control.
Researchers from Virginia Polytechnic Institute and State University filed for protection of their development of a slim, painless, and affordable microfluidic infusion pump device for the continuous transdermal delivery of drugs.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cytovale, Epiminder, Implantica, Moleculight, Spirair.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Glucotrack, Medtronic, Presidio Medical, Thermo Fisher.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bosotn Scientific, Neurent, Viz.ai.
Fineheart SA will soon begin a first-in-human study of Flowmaker, its fully implantable left ventricular assist device, in France, after receiving authorization from the French National Agency for the Safety of Medicines and Health Products to initiate the trial.
The bankruptcy of genetic testing service 23andme Holding Corp. prompted a reaction from many quarters, but a June 11 Senate hearing highlighted an interest in federal privacy legislation that would be directed toward genetic privacy as well as comprehensive and preemptive federal privacy legislation.
The U.K.’s National Health Service reported June 10 that patients in the U.K. will be the first in Europe to enjoy the benefits of the Edison ultrasound histotripsy for ablation of liver cancer tumors as part of an effort to bring products to market more quickly to deal with unmet needs.
South Korea’s Ministry of Food and Drug Safety on June 9 approved Vuno Inc’s AI-based Med-DeepECG Kidney software as a non-invasive method to screen for kidney dysfunction.