Latest Clinical Guidelines News

ImpediMed reported a 3% revenue increase to $3.6 million in Q4 FY26, bolstered by a $15.3 million capital raise and strategic leadership hires as it pushes growth in cancer survivorship, heart health, and weight management.

Cyclopharm Limited delivered a record $17.1 million in revenue for 1H FY26, driven by a 73% surge in US Technegas® sales. However, delays in clinical guideline publication have pushed the short-term US installation target beyond 2026, while medium-term ambitions remain intact.

Pacific Edge reported a steep 47% revenue drop in FY26 following Medicare coverage loss but secured a draft Medicare policy covering its Cxbladder tests and raised NZ$25.4 million to fuel growth and commercial execution.

Pacific Edge launches a NZ$6 million retail share offer at NZ$0.17 per share following a NZ$25.4 million institutional placement, aiming to strengthen its balance sheet and support Medicare reimbursement efforts for its bladder cancer diagnostics.

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

Cyclopharm Limited is rapidly expanding its Technegas® lung imaging technology across the US, securing new contracts and advancing clinical guideline recognition that could boost adoption.

Telix Pharmaceuticals has resubmitted its New Drug Application to the FDA for TLX101-Px (Pixclara®), aiming to advance a novel PET imaging agent for glioma diagnosis. The resubmission addresses prior regulatory concerns with additional data, reinforcing hopes for expedited approval.

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.