The U.S. FDA has granted breakthrough device designation for Bioventrix Inc.’s Revivent Tc Transcatheter Ventricular Enhancement System for heart failure following a heart attack. The system is designed to exclude scar tissue that has formed on the left ventricle in a procedure that is less invasive than current medical options and better than drug therapy, allowing healthy heart tissue to function more efficiently. The left ventricle is the heart’s pumping chamber, and scarring can prevent it from contracting and providing the steady circulation of blood that the body needs.

The FDA’s Safer Technologies Program, or STeP, is part of an overarching emphasis on safety, and the related draft guidance focuses largely on the process of applying for a STeP device. However, a member of the FDA staff said on a webinar that device accessories – and devices that make other devices safer – are also eligible for the program.

The U.S. FDA has given its final approval to Coopervision Inc.'s Misight 1 day, the first contact lens designed to slow the progression of myopia, or near-sightedness, in children. The single use, disposable, soft contact lens is indicated for children who are diagnosed with myopia and begin Misight treatment at an early age. Specifically, the FDA indication said that "Misight (omafilcon A) daily wear single use soft contact lenses are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤ 0.75 diopters of astigmatism. The lens is to be discarded after each removal."

Oxford University startup Ultromics Ltd. has won the U.S. FDA's nod for its artificial intelligence (AI) image analysis system for diagnosing coronary artery disease. Called Echogo Core, the system is intended to serve as an aid to cardiologists in evaluating echocardiograms of patients referred with symptoms such as shortness of breath and chest pain. Ross Upton, co-founder and CEO of Ultromics, called the clearance a "watershed moment" for the company, which began developing its algorithm-based system in 2011 and was spun out of Oxford University in 2017. The next stage for the company is commercializing the product and bringing it to clinicians in the U.S. Ross said the company expects to launch the product in the beginning of next year.