Latest Fda Submission News

Optiscan Imaging has submitted its FDA dossier for InSpecta®, marking a crucial step toward US veterinary market entry, while progressing clinical studies for InVue® and InForm® ahead of further FDA submissions in 2026.

BlinkLab has completed onboarding all clinical sites for its pivotal FDA autism trial, enrolled the first participant, and launched a nationwide autism screening program in Morocco. A recent A$17.7 million capital raise will fund further trials and expansion into ADHD diagnostics.

Epiminder has ramped up enrolment in its DETECT study, contracting 18 US medical centres and maintaining a robust $83.8 million cash position to fund its Minder device commercialisation through 2028.

Cleo Diagnostics (ASX:COV) has hit a major milestone by completing sample collection for its pivotal U.S. ovarian cancer trial, while progressing manufacturing and analytical validation steps toward FDA 510(k) submission.

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

LTR Pharma has wrapped up recruitment for its SPONTAN Phase II pharmacokinetic study, with interim results expected soon to bolster FDA approval efforts. Meanwhile, US commercial talks for ROXUS advance cautiously under the FDA 503(a) personalised medicine pathway.

Cleo Diagnostics has kicked off a staged manufacturing program with Bio-Techne to produce ovarian cancer test kits, moving from clinical sample collection to analytical validation and FDA submission preparation.

Imricor Medical Systems advanced FDA clearances and expanded clinical trials in Q1 CY26, positioning for commercial growth despite higher operating cash outflows.

Lumos Diagnostics has secured a key FDA 510(k) clearance with CLIA waiver for its FebriDx rapid test, unlocking a US$1 billion-plus market opportunity and triggering milestone payments exceeding US$6 million. The company reported a 37% revenue jump in Q3 FY26, supported by a A$20 million placement and ongoing clinical and development projects.

ReNerve has moved its NervAlign Nerve Guide Matrix into stage 3 of commercial development, a key step toward FDA submission and eventual market entry. This progress supports the company’s ambition to provide surgeons with an alternative to donor nerves for repairing severe peripheral nerve injuries.

Nexsen Limited (ASX:NXN) has completed its Stage 1 ISO 13485 audit, confirming its Quality Management System (QMS) supports clinical validation and regulatory submissions for its diagnostic products, including StrepSure®. The company is progressing toward full certification and alignment with MDSAP requirements to facilitate global market access.

Cleo Diagnostics has completed blood sample collection for its pivotal U.S. clinical trial, advancing its Pre-Surgical Ovarian Cancer Test closer to FDA submission.