Respiri (ASX:RSH) share price on watch following FDA approval

The Respiri Ltd (ASX:RSH) share price is on watch after the company announced it's received US FDA clearance for its asthma device and app.

medical asx share price represented by doctor giving thumbs up

Image source: Getty Images

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The Respiri Ltd (ASX: RSH) share price is on watch today after the company advised it has received United States Food and Drug Administration (FDA) clearance for its Wheezo app. 

About Respiri  

Respiri is a software-as-a-service (SaaS) company supporting asthma patients to monitor and manage their asthma. The company views that asthma is often under-diagnosed and under-treated, creating a substantial burden to sufferers and their families. 

Respiri has created an eHealth SaaS platform, 'Wheezo', that uses a device and app to measure, record and monitor asthma symptoms. The device records breath sounds over 30 seconds to be analysed in the app. The app has features that allow users to log symptoms, triggers, medication and local environment factors, which can then be used to build a personalised asthma profile to be shared with healthcare professionals. 

The company believes the sub-optimally managed asthma market represents a significant opportunity, with over 340 million people affected globally. 

Respiri share price in focus 

The Respiri share price will be on the radar this morning after the company announced it has received clearance from the US FDA for Wheezo, thus permitting the company to market and sell its product in the US as a class II medical device alongside the Wheezo app. 

Respiri CEO and Managing Director Mr Marjan Mikel commented on clearance: 

The regulatory clearance of Wheezo and our App in the United States represents a highly significant and major milestone for the Company as we continue to expand our regulatory footprint for Wheezo and enter substantial new markets. The FDA is one of the most stringent regulatory bodies in the world and this clearance further validates the efficacy and utility of our Wheezo device and algorithm. To our knowledge [this is] the first time the FDA has cleared a device/mobile application for the detection, recording and changes of wheeze rates. This represents a step-change in technology for patients with respiratory wheeze seeking an effective, replicable and rapid device measurement and associated App that monitors this important measurement of lung function.

Respiri plans to launch in the US market in Q3 2022 with an initial focus on the 60% of children with persistent and severe asthma, representing 3.3 million patients. According to the company, the Wheezo device and app will play a role in providing significant analytical information for patients and their caregivers. 

Respiri highlights the reimbursement codes available from the Centers for Medicare and Medicaid Services (CMS) in the US as a key tailwind for Wheezo. These enable clinicians and qualified medical professionals advising patients on the purchase of the device and associated SaaS fees to receive financial compensation for the time spent and equipment used for patient care delivered remotely. 

Wondering where you should invest $1,000 right now?

When investing expert Scott Phillips has a stock tip, it can pay to listen. After all, the flagship Motley Fool Share Advisor newsletter he has run for over ten years has provided thousands of paying members with stock picks that have doubled, tripled or even more.*

Scott just revealed what he believes could be the 'five best ASX stocks' for investors to buy right now. We believe these stocks are trading at attractive prices and Scott thinks they could be great buys right now...

See The 5 Stocks *Returns as of 30 April 2025

Motley Fool contributor Kerry Sun has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.

More on Share Market News

A cute little kid in a suit pulls a shocked face as he talks on his smartphone.
Share Market News

Telstra share price hits 8-year high amid a lacklustre trading week

The ASX 200 communications services sector was the best performer last week, rising 2.96%.

Read more »

share buyers, investors, happy investors
ETFs

How I would build a $100,000 portfolio with ASX ETFs today

You don't need more than three ETFs to build a diversified portfolio...

Read more »

A young man pointing up looking amazed, indicating a surging share price movement for an ASX company
Broker Notes

These ASX 200 shares could rise 20% to 100%

Analysts are expecting these shares to deliver big returns over the next 12 months.

Read more »

Three people in a corporate office pour over a tablet, ready to invest.
Broker Notes

Top brokers name 3 ASX shares to buy next week

Brokers gave buy ratings to these ASX shares last week. Why are they bullish?

Read more »

The silhouettes of ten people holding hands with their arms raised against the sky, as the sun rises or sets in the background.
Share Gainers

Here are the top 10 ASX 200 shares today

ASX shares finished the trading week on a high this Friday.

Read more »

A businessman stacks building blocks.
Technology Shares

6% gain! What's up with Block shares today?

Block shares are up more than 34% since 2 May.

Read more »

Broker looking at the share price.
Broker Notes

Brokers name 3 ASX shares to buy today

Here's why brokers are feeling bullish about these three shares this week.

Read more »

A young man punches the air in delight as he reacts to great news on his mobile phone.
Share Gainers

Why ARB, Block, Mayne Pharma, and Paladin Energy shares are charging higher today

These shares are having a strong finish to the week. But why?

Read more »