Brisbane, Calif.-based Caption Health Inc. received good news from the U.S. FDA, which has given a thumbs up to Caption Guidance. This software aims to assist medical professionals in the acquisition of cardiac ultrasound images and uses artificial intelligence (AI) to provide real-time guidance.
The FDA has granted over-the-counter (OTC) clearance to the first noninvasive wearable to treat stress urinary incontinence. The device, known as Innovo, uses electrical stimulation to strengthen pelvic floor muscles and is integrated into fitted shorts. It was already available by physician prescription in the U.S. since an FDA clearance in early 2019.
PARIS – Carmat SA, from Vélizy-Villacoublay, France, has obtained full FDA approval for its investigational device exemption application (IDE). The company is now able to initiate a U.S. early feasibility study (EFS) of its total artificial heart. “This full approval to initiate a U.S. study confirms the FDA’s confidence in our ability to conduct a feasibility study of the first bio-prosthetic artificial heart in the United States,” Stéphane Piat, CEO of Carmat, told BioWorld.
FDA warning letters to device makers have been conspicuous in their paucity in recent years, but they have been surfacing with greater frequency over the past few months.
The FDA has awarded a breakthrough device designation to a polymer film implant to create an artificial endothelial layer in the eye. Known as Endoart, it is designed to replace a non-functioning endothelium, which is the single layer of cells on the inner surface of the cornea. Without it, excess fluid flows into the cornea and can result in severe vision loss.
Aria CV Inc., which focuses on pulmonary arterial hypertension (PAH), has won a breakthrough device designation from the U.S. FDA for the Aria CV pulmonary hypertension (PH) system. The implanted Aria CV PH system aims to restore the benefits of a healthy, elastic pulmonary artery, which in turn reduces cardiac workload and enhances blood flow.
A half-day open meeting intended to examine “how the public perceives and values pharmaceutical quality,” convened by the Robert J. Margolis Center for Health Policy at Duke University in cooperation with the FDA, included a rundown of the agency’s oversight program, results of surveys to measure viewpoints of patients and providers – and tart commentary from a two-member “reactant panel.”
Aimmune Therapeutics Inc. wasted no time moving ahead after last week’s FDA approval of Palforzia for peanut allergy as the Brisbane, Calif.-based company obtained an exclusive worldwide license to develop and commercialize Xencor Inc.’s humanized monoclonal antibody, XmAb-7195, for treating allergic asthma.
The U.S. FDA has given its nod for a new trial of Abbott Laboratories’ Amplatzer Amulet left atrial appendage (LAA) occluder for those with atrial fibrillation (AF) who are at risk of stroke. Known as the CATALYST trial, it is the first study comparing the effectiveness of a LAA closure device to non-vitamin K antagonist oral anticoagulant (NOAC) drugs, a newer class of blood thinners, the Abbott Park, Ill.-based company said.
The FDA has issued two new approvals, one for a cell-based pandemic influenza A (H5N1) vaccine and the other is the first approval for treating peanut allergy.
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