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Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing VCD Medical clears VEnice, a clip that closes varicose veins without heat Sofinnova closes an 82 million euro fund to start six to eight device companies Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line Insera clears the CLEAR aspiration system for peripheral clot removal under K253404 Webster Equity takes Lifecore Biomedical private at $6.28 a share plus CVRs Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing VCD Medical clears VEnice, a clip that closes varicose veins without heat Sofinnova closes an 82 million euro fund to start six to eight device companies Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line Insera clears the CLEAR aspiration system for peripheral clot removal under K253404 Webster Equity takes Lifecore Biomedical private at $6.28 a share plus CVRs

Pre-submission

Autonomix says FDA backed a Class II path for its sensing catheter and targets clearance in 15 months

MedDevice Startups Staff · 1 day ago · 2 min read · Via GlobeNewswire

Autonomix Medical said on September 30 that FDA supported a Class II route for its sensing platform at a pre-submission meeting. The company plans to claim substantial equivalence to a device already cleared. It is targeting US clearance in about 15 months, subject to development and validation work and to FDA review. Autonomix named neither the predicate nor a lead indication.

The platform is a catheter-based microchip sensing array built to pick out faint biological signals. It is aimed at transvascular diagnosis and treatment of peripheral nervous system disease, and Autonomix lists cardiology, hypertension and chronic pain as targets. Splitting the sensing array off as a standalone 510(k) gets a platform on the market before the therapy data lands.

Questions & Answers

What did FDA tell Autonomix Medical at its pre-submission meeting?

Autonomix said on September 30, 2026 that FDA supported a Class II pathway for its sensing platform, using substantial equivalence to a device already cleared. The company did not name the predicate.

When does Autonomix Medical expect FDA clearance for its sensing platform?

Autonomix is targeting US clearance in roughly 15 months from its September 30, 2026 announcement, subject to finishing development and validation work and to FDA review.

What is Autonomix Medical's sensing platform?

It is a catheter-based microchip sensing array designed to detect and differentiate faint biological signals for transvascular diagnosis and treatment of peripheral nervous system disease. Autonomix lists cardiology, hypertension and chronic pain as potential applications.

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