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


CytoCore’s SoftPap

This article was originally published in The Gray Sheet

Executive Summary

Cancer screening test firm CytoCore receives 510(k) clearance for its SoftPap cervical cell collector Jan. 30 and plans to sign its first U.S. distribution agreements in the coming days for launch by the end of March, the firm said Feb. 5. SoftPap consists of a reusable handle and disposable balloon, which inflates inside the body to collect cervical cells. CytoCore says the system collects better samples than the alternative spatula and brush collection method, and could be used with Cytyc/Hologic's ThinPrep liquid-based Pap test and BD/TriPath's SurePath test. The device will cost $10-$12 out-of-pocket, compared to less than $1 for the reimbursed brush technique, but will "more than prove to be cost-effective," marketing director Dan McMahon claims. SoftPap has been sold in Europe since late December

You may also be interested in...

Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

World-First Nod For Yuhan's Lung Cancer Drug, In Korea

The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.

DePuy Synthes Gains US FDA Clearance For Velys Robot For Total Knee Surgery

DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.




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