FDA

Using bioimpedance spectroscopy, the SOZO® Digital Health Platform aims to provide clinicians with a more precise measure of fluid volume to be removed from a renal failure patient during dialysis.

The Humelock glenoid baseplate is a 24mm round baseplate is available in four options.

The designation means the FDA will prioritize Impella ECP’s regulatory review processes including design iterations, clinical study protocols and pre-market approval (PMA) application.

Patient enrollment is expected to commence during the second half of 2021. The study's primary and secondary endpoints, PFO Closure and recurrent stroke, respectively, will be evaluated at the 12-month patient follow-up.

The EXALT Model B Bronchoscope was designed to bring a new level of suction and imaging performance to single-use scopes and offers a familiar design and feel to that of a reusable device.

"Pompe disease is a rare genetic disease that causes premature death and has a debilitating effect on people's lives," said Janet Maynard, M.D., deputy director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA's Center for Drug Evaluation and Research. "Today's approval brings patients with Pompe disease another enzyme replacement therapy option for this rare disease. 

"The next-generation remedē System is built on the proven success of the current platform, with the needs of both patients and clinicians in mind," said Pete Sommerness, President of ZOLL Respicardia.