Reflexonic LLC landed FDA clearance for the first hand-held, non-pharmaceutical device intended to help men with moderate erectile dysfunction, poor maintenance and rigidity or spinal cord injuries achieve successful erection and ejaculation at home.
Viberect is the only device in the world that delivers targeted vibration applied to the top and bottom of the penis using medical pads that stimulate the pudendal and dorsal nerves.
The tool is indicated for use prior to sexual activity and claims to amplify subsequent orgasm and ejaculation.
"The proprietary Viberect method mimics rapid and repetitive manual/vaginal stimulation of the penis, which is a natural aspect of sexual behavior of humans and higher mammals," according to the Chambersberg, Penn.-based urology company’s website.
Reflexonic called on Texas-based medical device consultancy firm Emergo Group to aid it through the regulatory bid, and the companies spent two months writing the 510(k) application, which was submitted in February, according to the press release.
"Reflexonic is now set to begin marketing the first hand-held, non-pharmaceutical device to provoke natural penile erection and ejaculation in the US," Reflexonic founder and president Dr. Kambiz Tajkarimi said in prepared remarks. The company is set to begin selling Viberect this summer.
Nephros Inc. (OTC:NEPH) landed 510(k) approval to market additional ultrafiltration products filtering out biological contaminants for water and solutions used in hemodialysis procedures. The River Edge, N.J.-based company also produces filtering products for therapeutic applications, infection control and water purification.
Minimally Invasive Devices Inc. announced European regulatory approval for its FloShield laparoscopic visualization system. The Colombus, Ohio-based company’s device uses airflow to defog and deflect debris from the lens of the laparoscope without requiring removal from the abdominal cavity.