Noah Medical announced today that a hospital in Hong Kong conducted the first use of its Galaxy surgical robot system in Asia. Dr. Calvin Ng and Dr. Rainbow Lau performed the first use of Galaxy at Prince of Wales Hospital. The procedure marks the beginning of the first clinical trial of the robotic bronchoscopy system […]
Clinical Trials
Qnovia has positive results for inhaled smoking cessation therapy
Qnovia announced positive results from its first-in-human study for the QN-01 inhaled smoking cessation therapy. Richmond, Virginia-based Qnovia develops the RespiRx drug delivery platform that leverages a vibrating mesh nebulizer. CEO Brian Quigley explained the technology to Drug Delivery Business News last year. The company designed the QN-01 therapy to meet the need for safe and effective […]
Procyrion enrolls first patient in IDE trial for mechanical circulatory support tech
Procyrion announced today that it enrolled the first patient in its investigational device exemption trial of the Aortix system. The DRAIN-HF study evaluates the Aortix percutaneous mechanical circulatory support (pMCS) technology. Patients in the trial present acute decompensated heart failure (ADHF) and remain unresponsive to standard medical therapy. Dr. Bassem Chehab enrolled the first patient […]
ReValve reports successful first-in-human implant of next-gen TMVR
ReValve Solutions announced today that doctors successfully treated the first patient with its next-generation replacement heart valve. Cardiologists at the Punta Pacifica Hospital, Panama City, Panama, performed the procedure. An 81-year-old male with a history of heart failure received the Palmetto transcatheter mitral valve replacement (TMVR). The patient also had a series of failed surgical […]
BiVacor wins FDA IDE for first-in-human artificial heart study
BiVacor announced today that the FDA granted investigational device exemption (IDE) for its total artificial heart (BTAH). IDE approval allows BiVacor to begin its first-in-human early feasibility study (EFS) for the BTAH system. The Houston-based company aims to evaluate BTAH’s safety and feasibility as a bridge to a heart transplant for patients with biventricular heart […]
First patient enrolled in Penumbra study of computer-assisted vacuum thrombectomy
Penumbra (NYSE:PEN) today announced the first patient enrolled in STORM-PE, a trial of its Lightning Flash thrombectomy system. Lightning Flash, a mechanical thrombectomy system, received FDA clearance in January. The system features Penumbra’s novel Lightning intelligent aspiration technology with dual-clot detection algorithms. Combining it with innovative catheter engineering, Penumbra designed Lightning Flash to quickly remove […]
ReWalk Robotics demonstrates proof-of-concept with next-gen, AI-powered exoskeleton
ReWalk Robotics (Nasdaq:RWLK) announced today that it successfully demonstrated proof-of-concept with its next-generation exoskeleton. The Israel-based company, which operates out of Marlborough, Massachusetts, in the U.S., incorporated AI into its latest technology. It integrated advanced sensing technologies and AI to enable autonomous decision-making in the new exoskeleton prototype. ReWalk hit this milestone as part of […]
iCad AI tech accurately predicts breast cancer risk, provides heart disease insights
iCad (Nasdaq:ICAD) today announced plans to present new studies validating its AI-powered ProFound Breast Health Suite. ProFound helps to uncover hidden heart or vascular disease and predict a woman’s risk for developing breast cancer in the next 1-2 years. The platform can screen a single mammogram for two of the top causes of death for […]
Element Science has positive data for patch-wearable defibrillator
Element Science announced positive data from a study of its Jewel patch-wearable cardioverter defibrillator (P-WCD). The FDA investigational device exemption evaluated Jewel for sudden cardiac arrest (SCA) prevention across 305 patients. San Francisco-based Element Science developed Jewel with patient experience in mind, creating a low-profile, lightweight design. The water-resistant device allows patients to comfortably wear […]
Teleflex enrolls first patient in registry of vascular closure device for TAVR
Teleflex announced today that it enrolled the first patient in a clinical registry evaluating its Manta vascular closure device (VCD). The company aims for the registry to examine and collect data on outcomes of contemporary on-label use of Manta in standard of care transcatheter aortic valve replacement (TAVR) procedures. It includes appropriate patient selection and […]
Surmodics has positive data on multiple drug-coated balloons
Surmodics (Nasdaq:SRDX) today announced positive study results for two of its drug-coated balloon (DCB) technologies. The company presented data supporting the SurVeil and Sundance DCBs at the 50th Annual VEITH Symposium in New York. In the TRANSCEND trial, Surmodics evaluated the safety and efficacy of SurVeil versus the Medtronic In.Pact Admiral DCB. The trial evaluated […]