MarketPulse

FDA clearance

18 articles
BenzingaBenzinga··Prnewswire

IceCure's ProSense Cryoablation Gains Momentum as Q1 Revenue Surges 30%

IceCure Medical showcased ProSense® cryoablation at breast surgeons conference, reporting 30%+ Q1 revenue growth as adoption accelerates.
ICCMbreast cancerFDA clearance
GlobeNewswire Inc.GlobeNewswire Inc.··Delveinsight

Perfusion Systems Market Poised for Steady Growth as Cardiac Demand Surges

Global perfusion systems market projected to grow 5% annually from USD 1.5B (2025) to USD 2.4B (2034), driven by cardiovascular disease prevalence and transplant procedures.
MDTGNGBYLIVNFDA clearancemedical devices
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Aktis Oncology Advances Radioconjugate Pipeline With First AKY-2519 Clinical Data

Aktis Oncology presents inaugural clinical data for AKY-2519 radioconjugate at ASCO 2026, with Phase 1b trial launching mid-year following FDA IND clearance.
AKTSsolid tumorsFDA clearance
GlobeNewswire Inc.GlobeNewswire Inc.··Equity-Insider.Com News Commentary

Cardiac Care Boom: $22B Market Poised to Double by 2032 on AI, Aging

U.S. cardiovascular devices market projected to nearly double to $41.29B by 2032, driven by aging demographics and AI-powered tools.
JNJMDTISRGGEHChealthcare technologyAI integration
GlobeNewswire Inc.GlobeNewswire Inc.··Royal Philips

Philips Wins FDA Clearance for AI-Powered Spectral CT System Verida

Philips gains FDA clearance for Verida, an AI-powered spectral CT system enabling 270 daily exams and sub-30-second scan times.
PHGFDA clearancedeep learning
GlobeNewswire Inc.GlobeNewswire Inc.··Not Specified

TScan Therapeutics Advances TCR Cell Therapy Pipeline With FDA Clearance, Conference Participation

TScan Therapeutics secures FDA clearance for two IND applications and completes Phase 1 trial enrollment using commercial-scale manufacturing, advancing its TCR cell therapy pipeline.
TCRXclinical-stage biotechsolid tumors
BenzingaBenzinga··Prnewswire

BrainStorm Charts Recovery Path With $2M Funding as NurOwn Advances to Pivotal ALS Trial

BrainStorm Cell Therapeutics reported $10.3M net loss for 2025 while securing $2M financing and advancing NurOwn into Phase 3b ALS study following FDA clearance.
BCLIfinancial resultsprivate placement
BenzingaBenzinga··Prnewswire

Pulsenmore Surges 374% on GE Settlement, FDA Clearance Opens Prenatal Ultrasound Market

Pulsenmore ($PLSM) reported $12.5M revenue in 2025, up 374% YoY, buoyed by $9.6M GE settlement. FDA clearance for remote prenatal ultrasound and European CE certification enable market expansion.
PLSMFDA clearancecommercial expansion
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Philips Launches IntraSight Plus to Slash Cathlab Operating Times by Nearly Half

Philips launches FDA-cleared IntraSight Plus interventional platform, offering up to 47% cathlab operation time savings with integrated diagnostic and treatment planning capabilities.
PHGFDA clearanceminimally invasive procedures
BenzingaBenzinga··Prnewswire

IceCure Medical Bolsters Leadership Team with CFO, Medical Director Appointments

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.
ICCMbreast cancerleadership
The Motley FoolThe Motley Fool··Motley Fool Transcribing

Tenon Medical Doubles Q4 Revenue on FDA Clearance, Eyes Aggressive 2026 Expansion

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.
TNONTNONWrevenue growthfinancing
BenzingaBenzinga··Prnewswire

KLYG Cuts Losses 85% Despite Revenue Dip, Secures FDA Win for Fusion Implants

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

ASBrS Endorses Cryoablation for Low-Risk Breast Cancer, Boosting IceCure Medical

ASBrS endorses cryoablation for low-risk breast cancer, validating IceCure Medical's ProSense system cleared by FDA in October 2025.
ICCMbreast cancerFDA clearance
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Microbot Medical Affirms Stability, Accelerates LIBERTY Robot Expansion Despite Geopolitical Tensions

Microbot Medical confirms uninterrupted USA and Israel operations amid geopolitical tensions, accelerating LIBERTY robotic system expansion with planned April 2026 commercial launch.
MBOTFDA clearancerobotic surgery
GlobeNewswire Inc.GlobeNewswire Inc.··Na

TScan Advances Allogeneic Cell Therapy Pipeline With FDA IND Clearances and Trial Enrollment Milestones

TScan completes Phase 1 trial enrollment and receives FDA clearance for two allogeneic cell therapy candidates, advancing its pipeline toward pivotal studies in 2026.
TCRXclinical trialTCR-T therapy
GlobeNewswire Inc.GlobeNewswire Inc.··Serina Therapeutics

Serina Therapeutics Advances SER-252 Development With First Phase 1b Enrollee

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.
SERFDA clearancePhase 1b trial
GlobeNewswire Inc.GlobeNewswire Inc.··Na

BioRestorative Closes $5M Equity Offering to Fund Stem Cell Pipeline

BioRestorative raised $5M through equity offering to advance stem cell therapies, including BRTX-100 for spine disease and metabolic disorder research.
BRTXclinical trialsregenerative medicine
BenzingaBenzinga··Vandana Singh

Medtronic Gains FDA Clearance for Advanced Spine Surgery Navigation System

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.
MDTFDA clearancemedical device