In Brief: U.S. Surgical Abbi
This article was originally published in The Gray Sheet
Executive Summary
U.S. Surgical Abbi: USSC will provide clinical data to FDA on its Abbi minimally invasive breast biopsy system in an ongoing effort to convince the agency to allow marketing of the device under its current 510(k). U.S. Surgical says it expects a "positive" outcome to the discussions and notes that it can continue selling the device pending resolution of the issue. The firm announced June 4 that FDA had indicated it may have made an error in issuing the 510(k) and was considering rescinding the premarket notification clearance ("The Gray Sheet" June 10, I&W-10). USSC also is holding discussions with the agency to resolve outstanding labeling and advertising issues regarding the Abbi system raised in a June 3 warning letter to the company...
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.