Envoy Medical Corp. got some early support for its Acclaim fully implantable cochlear implant, with a breakthrough device designation from the U.S. FDA. If approved, it would be the first cochlear implant to address hearing loss without the use of any external components.
Precardia Inc. received some good news from the U.S. FDA, which has granted the company's catheter-based system for treating volume overload in patients with acutely decompensated heart failure (ADHF) breakthrough device designation. The device is intended to quickly reduce congestion in the venous system, known as cardiac preload, with an eye toward improving overall cardio-renal function.
Medrhythms Inc., a digital therapeutics startup based in Portland, Maine, won an FDA breakthrough device designation for its Rhythmic Auditory Stimulation (RAS) treatment platform for people with chronic walking impairments due to stroke.
The U.S. FDA granted Gtx Medical BV a breakthrough device designation for its implantable Go-2 Targeted Epidural Spinal Stimulation (TESS) system. The device enabled patients who had sustained traumatic spinal cord injuries to regain voluntary control over previously paralyzed muscles and walk again four or more years after paralysis, according to a study previously published in Nature.
Minneapolis-based startup Nuvaira Inc. has received breakthrough device designation from the U.S. FDA for its Dnerva lung denervation system to reduce the risk of moderate-to-severe exacerbations of chronic obstructive pulmonary disease (COPD) in patients receiving optimal care. The bronchoscopic procedure works by disrupting pulmonary nerve input to the lung, improving symptoms and stabilizing lung function.
Hydrocephalus involves the buildup of excess fluid in the brain. It affects more than 1 million people in the U.S. – most of them children – and can result in brain damage and related neurological impairments. Shunt implants are the standard treatment to drain that fluid, but more than half of them fail within the first couple of years of placement.
Waltham, Mass.-based Thermedical Inc. has received a breakthrough device designation from the U.S. FDA for its saline enhanced radiofrequency (SERF) ablation system and Durablate catheter in the treatment of ventricular tachycardia (VT). The system uses a new means of biological heat to precisely deliver ablation therapy to the heart.
Portland, Ore.-based startup Viscardia Inc. has received breakthrough device designation from the FDA for its implantable Visone system to treat moderate to severe heart failure with reduced ejection fraction and preserved ventricular synchrony. The minimally invasive implant works by stimulating a specific portion of the diaphragm.
LONDON – DNA Electronics Ltd. (DNAe) won a U.S. FDA breakthrough device designation for its semiconductor-based DNA sequencing technology Lidia-seq and for the first assay based on the platform, which will detect bloodstream infections and antimicrobial resistance (AMR) genes at point of care.
The U.S. FDA has granted breakthrough device designation to Vapotherm Inc. for its Oxygen Assist Module (OAM), for use with its Precision Flow assistive breathing systems. The new module is designed to aid clinicians in maintaining a targeted blood oxygen range in patients requiring oxygen therapy.