Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

In Brief: Urohealth

This article was originally published in The Gray Sheet

Executive Summary

Urohealth: Receives conditional IDE approval from FDA for clinical trials of RelaX, a valved intraurethral catheter for the management of female incontinence. The device is designed to be left within the urethra for 29 days. Urohealth claims that possible advantages of the Relax over similar devices such as UroMed's Reliance include decreased risk of infection, convenience and "ease of use." Unlike the Reliance, the Relax can be used during sexual intercourse, the company adds. Relax is priced "competitively" at approximately $110 a month or $1200-1500 a year. The conditional IDE approval allows the company "to begin filing for investigational review board (IRB) approvals at designated clinical sites around the country and to begin clinical trials as the IRBs approvals are granted." The company plans on conducting clinical trials with approximately 130 patients at up to 12 sites...

You may also be interested in...



ECHA Deliberates On Final Microplastic Proposal As Beauty Industry’s Fate Hangs In Balance

A combined final opinion on the European Chemicals Agency’s proposed microplastic restriction is expected from ECHA committees by year-end, at which point the European Commission will consider whether and when microplastic must be removed from all leave-on cosmetic products marketed in the EU.

QUOTED. 2 December. Laurent Faracci.

Butterfly Network’s CEO Laurent Faracci outlines the company’s growth strategy and plans for their “ultrasound-on-a-chip” technology after its merger with blank check company Longview Acquisition Corp. See what the company’s CEO said about it here.

Health Care Personnel, Long-Term Care Residents Should Get COVID-19 Vaccine First, ACIP Votes

CDC’s Advisory Committee on Immunization Practices votes 13-1 that these two groups be first in line for vaccination once FDA authorizes a vaccine and ACIP recommends it. Goal of vote is to guide health departments in placing vaccine orders.

UsernamePublicRestriction

Register

OM004514

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel