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Lumicell Submits New Drug Application for LUMISIGHT™ Optical Imaging Agent to U.S. FDA for Intraoperative Breast Cancer Detection and Removal

Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT™ Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). LUMISIGHT...

March 21, 2023

Surgery and Surgical Robotics

Asensus Surgical Receives FDA 510(k) Clearance For Pediatric Indication for Senhance Surgical System

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™ (PGS), announced that it has received 510(k) clearance from the FDA...

March 20, 2023

Uncategorized

DermaSensor Unveils Study Results Demonstrating Ability to Detect Skin Cancer With Device Granted FDA Breakthrough Designation

DermaSensor Inc., a health technology company equipping primary care physicians (PCPs) with a non-invasive device for use in evaluation of suspicious skin lesions, presented a pooled analysis today from two clinical studies evaluating the performance of the company’s device in...

March 17, 2023

Uncategorized

Prolira Announces FDA Clearance of the DeltaScan® Brain State Monitor for Detecting Acute Encephalopathy (Acute Brain Failure), a Condition Affecting Millions of Hospitalized Patients 60 and Older

Prolira BV, a high-tech company committed to enabling early and effective treatment of patients at risk of developing acute brain failure, announced it has received 510(k) clearance from the Food and Drug Administration (FDA) for the DeltaScan® Brain State Monitor...

March 16, 2023

Cardiovascular / Cardiology

HeartBeam Announces Acquisition of LIVMOR Assets

HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform for heart attack detection anytime, anywhere, announced the strategic acquisition of substantially all assets from LIVMOR, a digital health solutions company providing...

March 15, 2023

Diagnostics & Healthcare News

NanoVibronix Announces Positive Results from Independent Product Trial of UroShield for Patients with a Spinal Cord Injury

NanoVibronix, Inc., (NASDAQ: NAOV) (the “Company”), a medical device company utilizing the Company’s proprietary and patented low intensity surface acoustic wave (SAW) technology, today announced the positive evaluation results for its UroShield device, presented at a recent medical conference by...

March 14, 2023

Cardiovascular / Cardiology

Vivasure Medical Announces FDA IDE Approval to Initiate U.S. Pivotal Study

Vivasure Medical® Limited (“Vivasure” or the “Company”), a company pioneering novel fully absorbable technology for percutaneous vessel closure, announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study,...

March 13, 2023

Surgery and Surgical Robotics

Aquablation Therapy is the first surgical robotics system to receive a MedTech Innovation Briefing (MIB) from the National Institute for Health Care Excellence

PROCEPT® BioRobotics Corporation today announced Aquablation Therapy received a MedTech Innovation Briefing (MIB) from the National Institute for Health Care Excellence (NICE), for benign prostate hyperplasia (BPH) in the United Kingdom. NICE has recognized Aquablation Therapy is as effective as transurethral resection of the...

March 9, 2023

Orthopedics and Spine

X-Bolt Orthopedics Announces FDA 510(k) Clearance for Pro-X1™ Trochanteric Nail

X-Bolt, an emerging innovator of orthopedic devices, is pleased to announce that its hip fracture solution, the Pro-X1 Trochanteric Nail, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Pro-X1 will be X-Bolt’s flagship launch in the United...

March 7, 2023