Latest Clinical Guidelines News

Cyclopharm has achieved a key milestone with Technegas approved for clinical use at the US National Institutes of Health, marking a strategic advance in its American expansion. Installation is imminent, leveraging a federal procurement framework that could broaden Technegas applications beyond pulmonary embolism.

BlinkLab has expanded its pivotal FDA 510(k) autism diagnostic trial to nine top U.S. sites, adding Drexel University ahead of the Q1 2026 study start. This move follows a successful pilot study that exceeded FDA benchmarks, positioning BlinkLab Dx 1 for regulatory clearance.

TruScreen has been confirmed as a superior primary cervical cancer screening device in the world’s largest opto-electronic study, outperforming traditional cytology and matching HPV testing accuracy.

Cyclopharm Limited is accelerating its US market push for Technegas with a A$16 million capital raise following a record 2025 sales performance. The company aims to expand its US installations and advance new clinical applications beyond pulmonary embolism.

Cyclopharm has reported a record $32.3 million in operating revenue for FY2025, led by explosive growth in its U.S. Technegas market following FDA approval. The company reaffirms its ambitious target of 250–300 U.S. installations by mid-2026 amid strong clinical momentum.

Cyclopharm’s Technegas has been recognised as the preferred ventilation agent in a pivotal draft US lung imaging guideline, signalling a major boost for its adoption in American clinical practice.

Cyclopharm Limited has secured regulatory approval for its Technegas lung imaging technology in Colombia, marking its presence in 67 countries worldwide. This milestone aligns strategically with the upcoming global nuclear medicine congress in Cartagena.

Cyclopharm Limited reaffirms its ambitious target of 250–300 US Technegas installations by late 2026, driven by FDA approval, CMS reimbursement, and a growing pipeline of healthcare sites. The company reports record half-year revenue growth, signaling strong momentum in the expanding lung imaging market.

Medicare contractor Novitas plans to convene an expert panel in early 2026 to review coverage for Pacific Edge’s Cxbladder Triage test following the 2025 update to the American Urological Association microhematuria guideline.

Echo IQ Limited reported a sharp increase in losses for FY25 despite revenue growth, while securing FDA clearance and expanding its AI-driven cardiology platform across major US networks.

Pacific Edge Limited has opened a $5 million Share Purchase Plan at $0.10 per share, conditional on shareholder approval of a prior $16.1 million Placement. The capital raise aims to extend the company’s cash runway and accelerate US market adoption of its bladder cancer diagnostic tests amid Medicare non-coverage.

Pacific Edge has successfully raised NZ$16 million through an upsized equity placement, surpassing its initial target and setting the stage for a planned NZ$5 million Share Purchase Plan. The funds aim to accelerate clinical and commercial milestones, including regaining Medicare coverage for its cancer diagnostic tests.