Log in
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Dynamic quotes 
  1. Homepage
  2. Equities
  3. Australia
  4. Australian Stock Exchange
  5. ResApp Health Limited
  6. News
  7. Summary
    RAP   AU000000RAP5


SummaryMost relevantAll NewsOther languagesPress ReleasesOfficial PublicationsSector news

ResApp Health : TGA clearance achieved for wearable

03/24/2021 | 06:00pm EDT

View printer-friendly version

Brisbane, Australia, 25 March 2021 - ResApp Health Limited (ASX:RAP), a leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease, is pleased to advise that it has achieved Australian Therapeutics Goods Administration (TGA) clearance for its wearable as a Class I medical device and it is now listed on the Australian Register of Therapeutic Goods (ARTG). The development follows ResApp receiving CE Mark certification for the device earlier this month (refer ASX announcement: 2 March 2021).

TGA clearance will allow ResApp to progress the sale and marketing of the wearable in Australia.

ResApp's wearable is an easily worn, clip-on, unobtrusive device, which allows for continuous 24-hour patient monitoring using cough audio. When used in conjunction with ResApp's proprietary algorithms, the wearable has very high accuracy and precision - identifying over 93% of coughs events, with less than 1% of identified events being false positives.

The device has a number of applications. Initially, ResApp will introduce it into clinical trial settings to measure cough frequency. Cough frequency is a key factor in determining and managing respiratory disease progression and may also be a valuable outcome measure in clinical trials involving a broad range of disease states where cough is implicated.

CEO and Managing Director Dr Tony Keating said: 'We are pleased to have secured TGA clearance for our wearable which allows us to market and sell the product in Australia, our home market.

'We have achieved a considerable amount in a short time period in relation to our wearable device and cough counting technology. Since we secured CE Mark certification for the wearable earlier this month and announced our recent deal with AstraZeneca Japan, we have witnessed increased interest in our cough counting technology. We are particularly excited about the level of enquiry shown by large pharmaceutical and biotech companies that recognise the strong value proposition that our offering provides.'


About the Australian Register of Therapeutic Goods (ARTG)
The Australian Register of Therapeutic Goods (ARTG) is the central point of control for the legal supply of therapeutic goods in Australia. The ARTG is a database of information about therapeutic goods for human use approved for supply in, or exported from, Australia. It is the reference database of the Therapeutic Goods Administration (TGA).

About ResApp Health Limited
ResApp Health Limited (ASX: RAP) is a leading digital health company developing smartphone applications for the diagnosis and management of the respiratory disease. ResApp's machine learning algorithms use sound to diagnose and measure the severity of respiratory conditions without the need for additional accessories or hardware. ResApp's regulatory-approved and clinically validated products include ResAppDx, a smartphone-based acute respiratory disease diagnostic test for use in telehealth, emergency department and primary care settings; and SleepCheck, a smartphone application which allows consumers to self-assess their risk of sleep apnoea. Both products are CE Marked in Europe and TGA approved in Australia. For more information, please visit www.resapphealth.com.au.


ResApp Health Limited published this content on 25 March 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 April 2021 21:07:01 UTC.

© Publicnow 2021
07/05RESAPP HEALTH : Commercial agreement with Doctors on Demand in Australia
07/04Resapp Health Limited Signs A Commercial Agreement with Australian-Based Tele..
06/03RESAPP HEALTH : Medgate extends European ResAppDx trial
06/02Medgate Extends European ResAppDx Trial
05/17RESAPP HEALTH : Recruits First Participant in COVID-19 Study; Shares Jump 6%
05/16ResApp Health Limited Reports Recruited the First Participant in Its US-Based..
05/04RESAPP HEALTH : Signs Distribution Deal for Smartphone Diagnostic App in Kenya; ..
05/03RESAPP HEALTH : Agreement secured with Ilara Health to sell ResAppDx in Kenya
05/03Agreement with Ilara Health to sell ResAppDx in Kenya
04/12RESAPP HEALTH : Raises Over $4 Million in Placement
More news
Sales 2020 - - -
Net income 2020 -8,47 M -6,22 M -6,22 M
Net cash 2020 5,45 M 4,00 M 4,00 M
P/E ratio 2020 -14,6x
Yield 2020 -
Capitalization 34,4 M 25,2 M 25,2 M
EV / Sales 2019 -
EV / Sales 2020 -
Nbr of Employees 500
Free-Float 95,7%
Duration : Period :
ResApp Health Limited Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends RESAPP HEALTH LIMITED
Short TermMid-TermLong Term
Income Statement Evolution
Mean consensus -
Number of Analysts
Last Close Price 0,04 
Average target price
Spread / Average Target -
EPS Revisions
Managers and Directors
Tony Keating Chief Executive Officer, Executive Director & MD
Roger Aston Non-Executive Chairman
Udantha Abeyratne Chief Scientist
Rob Keniger Vice President-Technology
Christopher Ntoumenopoulos Non-Executive Director
Sector and Competitors
1st jan.Capi. (M$)
SAP SE12.70%169 087
INTUIT INC.38.35%144 819
SERVICENOW, INC.6.81%116 482
DOCUSIGN, INC.34.07%58 069