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

Cygnus prepares Glucowatch data for FDA:

This article was originally published in Clinica

Executive Summary

Cygnus has begun clinical trials to gather data for an FDA submission for Glucowatch, its automatic glucose-monitor, having completed development trials for the device. Redwood City, California-based Cygnus hopes to submit the data for either an 510(k) clearance or premarket approval application in mid-1999. The device, which is worn like a wristwatch, extracts glucose through the skin with low level electric current and can give up to three readings per hour for 12 hours. Possible future features include an alarm that sounds when glucose levels get too high or low and the ability to store three months data and to download it to a PC. In preliminary trials, involving 232 monitors, the device exceeded its internal accuracy target values by achieving a mean error of 15.6%, says the company.

You may also be interested in...



Italy Round-Up: Mylan And Polifarma Strike Deal, OTC Market Stable, Cholesterol-Lowering Probiotic Launch

The latest news from Italy's OTC and supplements markets, including the latest sales figures, business deals, product launches, ad regulation and local association activities.

Sandoz Pledges Price Stability Amid Coronavirus

Sandoz CEO Richard Saynor has pledged that the company will ensure stable pricing for essential coronavirus-related medicines amid concerns over how the outbreak will affect the supply chain.

Executives On The Move: Comings And Goings At Atara Biothera And Pfizer, Along With A Promotion At Domainex

T-cell immunotherapy firm Atara Biotherapeutics decides on a chief commercial officer and Pfizer oncology R&D head leaves for CSO spot at Vividion Therapeutics. Also, COO of UK drug discovery CRO Domainex is set to climb to CEO position.

Topics

UsernamePublicRestriction

Register

MT082847

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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