Latest Clinical Guidelines News

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.

A handful of healthcare names did the heavy lifting this week, driven by FDA wins, guideline upgrades, and big shifts in sales and cashflow. The flip side: several clinical-stage stocks fell hard as investors stayed picky about near-term proof and funding.

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.

Fisher & Paykel Healthcare reported a robust 14% revenue increase and a 39% jump in net profit for the first half of fiscal 2026, driven by strong clinical adoption and product innovation.

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.