V-Wave said yesterday that it won FDA breakthrough device designation for its interatrial shunt for pulmonary arterial hypertension, marking the second time in less than a month that the company has earned a breakthrough nod. The PAH shunt is designed to be placed in the heart through a catheter inserted via a vein in the […]
FDA clears HeartFlow Planner
HeartFlow said yesterday that it won FDA clearance for its Planner tool for coronary artery disease intervention. The Redwood City, Calif.-based company developed FFRct, which works by taking the data from a standard CT scan and applying algorithms that result in a color-coded 3D “map” detailing changes in flow across coronary lesions. The Planner virtual […]
FDA clears GE Healthcare X-ray algorithms
GE Healthcare said today that it has received FDA 510(k) clearance for its AI algorithms embedded in a mobile X-ray device. The mobile X-ray device was built in collaboration with the University of California San Francisco using GE Healthcare’s Edison platform. The AI algorithms, which the company calls Critical Care Suite, are designed to reduce […]
Checkpoint Surgical wins breakthrough device designation for nerve regeneration device
Checkpoint Surgical today said it received FDA breakthrough device designation for its brief electrostimulation therapy system. The Cleveland-based company’s brief electrostimulation therapy (BEST) system is designed to stimulate peripheral nerves to promote nerve regeneration when used with surgical intervention following a nerve injury, according to the company. “We are pleased to receive the Breakthrough Device […]
Ventrix touts first-in-human study of hydrogel to repair heart muscle
Bio-scaffold startup Ventrix said today it has safely conducted a first-in-human trial of an injectable hydrogel to repair cardiac tissue in patients who have suffered a heart attack. The FDA-approved, Phase 1 trial is the first to test a hydrogel made from the natural scaffolding of cardiac muscle tissue, also known as extracellular matrix, or […]
Cook Medical touts paclitaxel-coated stent PAD study results
Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to […]
EBR Systems wins FDA breakthrough nod for Wise CRT wireless pacer
EBR Systems said today that it has received breakthrough device designation from the FDA for its Wise CRT system for the treatment of heart failure. Sunnyvale, Calif.-based EBR Systems’ Wise system is a wireless pacer designed to improve the heart’s pumping ability by synchronizing the left and right ventricles to distribute blood to the lungs […]
New FDA de novo guidance emphasizes complete applications
The FDA has released final guidance to clarify exactly what medtech companies need to include in their requests for the agency to review their applications for de novo approval. The agency said it updated the guidance to comply with the Medical Device User Fee Amendments of 2017 goal to speed the product review process and […]
Masimo wins expanded clearance for O3 oximetry device
Masimo (NSDQ:MASI) said today that its O3 regional oximetry device has been cleared for three additional indices — delta cHb, delta HHb, and delta O2Hb. These indices provide clinicians with greater visibility into changes in the underlying oxyhemoglobin and deoxyhemoglobin components used to calculate cerebral oxygen saturation, or rSO2, the Irvine, Calif.-based company said. The […]
SoniVie wins FDA breakthrough device designation for pulmonary hypertension device
SoniVie last week won FDA breakthrough device designation for its Therapeutic Intra-Vascular Ultrasound System for patients with pulmonary arterial hypertension. The Therapeutic Intra-Vascular Ultrasound (TIVUS) System is a dedicated therapeutic ultrasound catheter that enhances the treatment of PAH, according to the company. It is inserted into the pulmonary artery during right heart catheterization and is […]
Nihon Kohden launches EEG device
Nihon Kohden (TYO:6849) today said it launched its VitalEEG wireless electroencephalogram headset in the U.S. The EEG system quickly evaluates brain-wave information of unconscious patients. It is designed for quick setup and efficient placement of electrodes within five minutes to allow clinicians to quickly assess brain health and determine the best treatment options for unconscious patients, […]
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