FDA Conditionally Grants Occlutech an IDE for PFO Study in U.S.

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.

FDA Approves New Treatment for Pompe Disease

"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. 

remedē EL-X System System FDA Approval

"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.

FDA Warns Firm with Over 15 Million Products Listed with FDA to Remove Unauthorized E-Cigarette Products from Market

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.

AnchorDx’s Non-invasive Bladder Cancer Early Detection Test, UriFind, Earns “Breakthrough Device Designation” from FDA

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.

FDA Grants Breakthrough Designation to Synapse Biomedical’s TransAeris® System

"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.

Nevro Announces FDA Approval of its 10 kHz High Frequency Spinal Cord Stimulation Therapy for Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy

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.

East End Medical Announces FDA Clearance Of Its SafeCross™ Transseptal RF Puncture And Steerable Balloon Introducer System

The SafeCross Transseptal RF Puncture & Steerable Balloon Introducer System will be on display at booth 1361 at the Heart Rhythm Society (HRS) meeting in Boston, MA on July 28-31, 2021.

Pulnovo Medical Completes the world’s 1st Pulmonary Hypertension RX Device RCT Study After Achieving FDA Breakthrough Designation

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.

Coronavirus (COVID-19) Update: June 22, 2021

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

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