ABK Biomedical this week announced it received FDA investigational device exemption approval for its Eye90 microspheres yttrium 90 radioembolization therapy. The FDA IDE approval allows the Halifax, Nova Scotia–based company to commence a multi-center pivotal clinical study in the U.S. involving patients with an especially tough-to-treat form of liver cancer. “FDA approval of this pivotal […]
Clinical Trials
Concept Medical wins FDA IDE approval for sirolimus coated balloon to treat superficial femoral artery disease
Concept Medical this week announced it received FDA investigational device exemption (IDE) approval for its sirolimus-coated balloon MagicTouch PTA to treat superficial femoral arteries. The approval is the fourth for the Tampa, Florida-based company’s sirolimus-coated balloon. It has IDE approval for coronary in-stent restenosis, coronary small vessel and below-the-knee indications. Concept Medical’s new IDE approval […]
Neuralink says FDA has OK’d a human trial
Elon Musk’s Neuralink says the FDA has approved a first-in-human clinical trial for its brain-computer interface technology. Neuralink said on Twitter yesterday: “We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study! This is the result of incredible work by the Neuralink team in close collaboration with […]
The top cardiac care innovation news at Heart Rhythm 2023
The future of cardiac care was on display at the Heart Rhythm Society’s 2023 annual meeting. Medical device companies showcased groundbreaking technologies at Heart Rhythm 2023, May 19-21 in New Orleans. The innovations presented during the event offer new avenues for diagnosis, treatment, and monitoring of cardiovascular conditions, providing hope for patients worldwide. Boston Scientific, […]
Research supports brain-computer interface tech from Onward
Onward Medical announced today that published data demonstrates the ability of its wireless brain-computer interface (BCI). The data, published in Nature, demonstrates how the BCI uses thought to modulate ARC therapy. Researchers say that, when paired with ARC therapy, an implanted BCI allowed an individual to gain augmented control over when and how he moved […]
Aerami presents positive data for inhaled pulmonary hypertension treatment
Aerami Therapeutics today announced positive data supporting its inhaled imatinib for treating pulmonary hypertension (PH). Studies of AER-901 support progression into a Phase 2 clinical trial. Data backed Aerami’s treatment for both PH associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). AER-901 is a drug-device combination. Aerami designed it to deliver potentially […]
Abbott CardioMEMS sensor nearly halves heart failure hospitalizations, study says
A recent European study found that the Abbott CardioMEMS HF System resulted in a 44% reduction in heart failure hospitalizations. Abbott also reported today that the study found an improvement in patient-reported quality-of-life scores as early as three months with the implantable remote monitoring sensor. Heart failure is a global health challenge affecting more than […]
Medtronic reports positive Harmony transcatheter pulmonary valve data
Medtronic (NYSE:MDT) announced positive two-year results for a study of its Harmony transcatheter pulmonary valve (TPV) system. Harmony treats severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT). The Medtronic analysis demonstrates strong clinical and hemodynamic outcomes for patients with a congenital heart defect of the RVOT. The current […]
Philips study shows AI can help predict ventricular tachycardia
Philips (NYSE:PHG) presented data demonstrating how artificial intelligence (AI) can help predict life-threatening ventricular arrhythmias. Amsterdam-based Philips presented an abstract highlighting recent research at the annual Hearth Rhythm Society (HRS) congress in New Orleans. The study, “Near-Term Prediction of Life-Threatening Ventricular Arrhythmias using Artificial Intelligence-Enabled Single Lead Ambulatory ECG,” used an AI-based learning model. It […]
Boston Scientific reports positive Farapulse, Watchman FLX data
Boston Scientific (NYSE:BSX) announced data supporting its pulsed-field ablation (PFA) and left atrial appendage closure (LAAC) systems. Studies backed the company’s key electrophysiology and cardiac rhythm management therapies, plus the Watchman FLX device. In addition to the LAAC device, the Marlborough, Massachusetts-based company shared data on its Farapulse PFA system, POLARx cryoablation system and the […]
Study supports extravascular ICD from Medtronic
Medtronic (NYSE:MDT) announced positive long-term follow-up results for its investigational implantable cardioverter defibrillator (ICD). The medtech giant designed its extravascular (EV) ICD system to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. Medtronic’s EV ICD pivotal study followed patients through an average of 17.1 months. The company presented data as late-breaking […]
