Cardiac Science's Powerheart gains Australian approval:
This article was originally published in Clinica
Executive Summary
The Australian Therapeutic Goods Administration has approved for sale Cardiac Science's automatic hospital bedside defibrillator-monitor, Powerheart. The Irvine, California-based company has signed an exclusive distribution agreement in Australia with CS Australia Pty, which has already resulted in the sale of 50 of the devices, it says. The device was cleared for sale in the US early last year (see Clinica No 894, p 17).
You may also be interested in...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.