Latest Regulated Markets News

Imricor Medical Systems has taken a significant step toward US market entry by submitting its Advantage-MR EP Recorder/Stimulator system for FDA 510(k) clearance, aiming to enhance MRI-guided cardiac procedures.

DataWorks has secured a significant contract extension with iGaming Ontario, adding over C$12.5 million to its Centralised Self-Exclusion program services. This move strengthens its recurring revenue and solidifies its RegTech division’s profitability.

Thrive Tribe Technologies reported a $186,000 net operating cash outflow in Q2 FY26, offset by a $300,000 equity raise to fund growth initiatives and operational expansion.

Clever Culture Systems has expanded its APAS Independence installed base to 27 instruments globally and surpassed $1 million in annual recurring revenue, underpinned by strong sales momentum and customer validation.

AdAlta Limited has aligned its AdCella manufacturing strategy with new US FDA guidelines, made a significant milestone payment to Shanghai Cell Therapy Group, and secured an additional R&D tax rebate, marking key progress in its cellular immunotherapy pipeline.

DataWorks Group has reported a robust turnaround with a $1.1 million positive operating cash flow in Q2 FY26, underpinned by major government contracts and validated social impact from its BetStop™ platform.

RAS Technology Holdings will not renew its Complete Racing Solution contract with Stake in 2026, shifting focus to expanding in regulated markets and Asia’s burgeoning racing sector.

PointsBet Holdings Limited has appointed Andrew Catterall as Group CEO effective February 2026, with founder Sam Swanell transitioning to an advisory role while remaining on the Board.

RAS Technology Holdings has landed a significant contract to provide racing data and managed trading services for LeoVegas Group’s UK brands, including BetMGM UK, marking a strategic expansion into regulated markets.

Echo IQ has completed its presentation to the CPT Editorial Panel for a Category III CPT code for EchoSolv AS, with a decision expected from the American Medical Association in the coming weeks. Meanwhile, the company is advancing US deployments and FDA clearance efforts.

Epsilon Healthcare’s manufacturing arm has secured updated GMP certificates covering domestic and EU/UK markets, reinforcing its quality credentials and paving the way for expanded international contract manufacturing.

Structural Monitoring Systems plc has reported its first profit after tax, driven by strong avionics sales and a successful $8.7 million capital raise. The company’s strategic shift towards proprietary products and key certifications underpin a positive outlook.