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.
"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.
Visible Vapors LLC, based in Pennsylvania that manufactures and operates a website selling electronic nicotine delivery system (ENDS) products, including e-cigarettes and e-liquids, received a warning letter from the FDA advising them that marketing these new tobacco products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S.
Compared with the traditional gold standard cystoscopy for bladder cancer detection, UriFind is non-invasive, painless, and easy to operate allowing for the accurate detection of bladder cancer by simply collecting random urine, providing the Test and conducting methylation detection of exfoliated cell DNA in urine.
"The Breakthrough Device designation for our TransAeris temporary diaphragm stimulation system is built upon our 20-year experience with NeuRx diaphragm pacing," said Anthony Ignagni, President & CEO of Synapse Biomedical.
This approval is specific to Nevro's unique 10 kHz stimulation, and Nevro now has the only spinal cord stimulation system approved by the FDA with a specific indication to treat PDN. The company will immediately initiate commercial launch activities in the U.S. under its recently launched HFX™ branding, as HFX™ for PDN.
The clinical data showed that: percutaneous pulmonary artery denervation significantly improved the 6-minute step of polytype pulmonary hypertension, and the mean pulmonary artery pressure and pulmonary vascular resistance were significantly reduced without related complications. In addition, percutaneous pulmonary artery denervation also has a therapeutic effect on mixed pre- and post-capillary pulmonary hypertension secondary to left heart failure.
FDA issued a Drug Communication for hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin and inhaling the vapors that linger. FDA