Imricor Medical Systems (ASX:IMR) Receives CE Mark Approval for Advantage-MR System
Imricor Medical Systems (ASX:IMR) secures CE Mark approval for its Advantage-MR system under the new EU Medical Device Regulation, anticipating EU launch in June.
Tag: Regulatory News & Compliance
CZR Resources Ltd (ASX:CZR) Announces Trading Halt
CZR Resources Ltd (ASX:CZR) announces a trading halt pending an update on the Robe River Joint Venture offer.
PainChek Ltd (ASX:PCK) Secures $1.41M R&D Tax Refund, Advances FDA Review, and Launches Infant App
PainChek Ltd (ASX:PCK) secures a $1.41m R&D tax refund, advances FDA review for its Adult App, and launches the Infant App on Apple App Store.
4DMedical Limited (ASX:4DX) Lodges Supplementary Prospectus
4DMedical Limited (ASX:4DX) lodges a supplementary prospectus amending the terms of its New and Piggyback Options offers.
The Star Entertainment Group Limited (ASX:SGR) Reinstates to Quotation
The Star Entertainment Group (ASX:SGR) reinstates trading suspension, resuming on April 16 after lodging its Appendix 4D and half-year financial report.
EBR Systems (ASX:EBR) Secures NTAP Reimbursement Approval
EBR Systems (ASX:EBR) proposes CMS approval of NTAP reimbursement for its WiSE CRT System, advancing US market strategy.
Silk Logistics Holdings (ASX:SLH) Announces ACCC Pauses Review Timeline
Silk Logistics Holdings (ASX:SLH) updates investors on ACCC pausing the review of its acquisition by DP World Australia, with the scheme meeting set for June 2025.
Osteopore Limited (ASX:OSX) Secures EU MDR Approval for Custom Implants
Osteopore (ASX:OSX) secures EU MDR approval for custom orthopaedic and cranial implants, expanding its market in Europe.
Dateline Resources Limited (ASX:DTR) Advances Colosseum Project with Mining Rights Confirmation
Dateline Resources (ASX:DTR) secures mining and rare earth exploration rights for its Colosseum Project, enhancing its growth prospects.
Cochlear Limited (ASX:COH) Responds to US Tariff Announcement
Cochlear Limited (ASX:COH) confirms it can continue duty-free imports of hearing implants despite new US tariffs.