US OKs Neoprobe's intra-operative blood flow measuring technology:
This article was originally published in Clinica
Executive Summary
Neoprobe has received US FDA 510(k) clearance to market its ultrasound-based system for the intra-operative measurement of blood flow. The Quantix/OR consists of an angle-independent ultrasound probe that obtains signals directly from the blood vessel and measures blood flow in the vessel regardless of vessel size. Dublin, Ohio-based Neoprobe said it would start clinical evaluations of the device at leading US institutions, with a view to supporting its efforts to develop a US market for the product through one or more established national sales representative organisations.
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.