FDA clearance

IceCure Medical ($ICCM) names Meir Peleg as CFO and appoints Dr. Richard Fine as Medical Director, capitalizing on ProSense® cryoablation system's FDA clearance momentum.

Tenon Medical reports 92% Q4 revenue growth to $1.5M, achieves 69% gross margins, secures FDA clearance and $4.3M financing for spine fusion device expansion.

$KLYG reported 85% net loss improvement to $138.6K on $3.05M revenue, secured FDA clearance for Fusion™ cranial implants, rejected acquisition offer.

ASBrS endorses cryoablation for low-risk breast cancer, validating IceCure Medical's ProSense system cleared by FDA in October 2025.

Microbot Medical confirms uninterrupted USA and Israel operations amid geopolitical tensions, accelerating LIBERTY robotic system expansion with planned April 2026 commercial launch.

TScan completes Phase 1 trial enrollment and receives FDA clearance for two allogeneic cell therapy candidates, advancing its pipeline toward pivotal studies in 2026.

Serina Therapeutics enrolls first patient in Phase 1b trial for SER-252, an apomorphine-based Parkinson's treatment. FDA alignment on regulatory pathway supports streamlined development timeline.

BioRestorative raised $5M through equity offering to advance stem cell therapies, including BRTX-100 for spine disease and metabolic disorder research.

Medtronic received FDA clearance for its Stealth AXiS spine surgery navigation system with real-time tracking technology, reducing need for intraoperative imaging and radiation exposure during procedures.