Adherium gets FDA approval for the sale of smart asthma inhaler sensors in the US
Adherium’s smart inhaler has got OTC clearance and it can now be sold directly to consumers without the need for the patients to first obtain a prescription.
Adherium has been creating technologies that solve problems in the health sector. They mostly offer solutions using technology in people suffering from chronic diseases where they can monitor their situation and achieve optimal adherence. They have clinical evidence which shows that the use of Haile technology in people who are asthmatic works in increasing adherence to preventing and maintaining medications in children and adults to reduce severe exacerbations. It has brought about better clinical outcomes.
Adherium’s Smartinhaler SmartTouch for Symbicort has now gotten approval from FDA to be selling asthma inhalers sensors in the US. They have received 510(K) clearance to market the smart inhaler sensor over the counter. The device will be installed in the inhaler so that it can monitor, promote asthma and COPD medication from the patient.
This approval means that Adherium will be able to sell the device directly to the consumer either online or through pharmacies without the consumer having a prescription first. The method can record the date and precise time by use of sensors where it automatically transmits the information to the tablet or phone through an app.
This smart inhaler stores information in the form of patterns which are later reviewed by physicians and from there they can make informed decisions.
The sensor has three buttons which allow patients to navigate quickly through the audio-visual reminders, Bluetooth, battery monitoring and wireless technology. The clearance of Adherium 510(K) brings in significant support from AstraZeneca’s Symbicort in the US. They have been cleared to sell individual versions of the device with either asthma inhalers ProAir HFA, Flovent HFA, Ventolin HFA.
“This latest clearance kicks off our official entry into the US consumer market, giving the tens of millions of US patients suffering from chronic respiratory conditions their sidekick for asthma and COPD,” Arik Anderson, CEO of Adherium, said in a statement.
“Over-the-counter sales of our Smart inhaler sensor for the Symbicort aerosol inhaler continues the advance of our vision for stronger partnerships between patients and physicians by making adherence to personnel management plans easier,” said Arik Anderson, CEO of Adherium. We are now well positioned to launch in the US, following successes in Europe and Australia.
We are providing clinically-proven monitoring to support patients in adopting their physicians’ guidance into their daily lives, and so close the gap between science and real-world care.
“There are about 25 million asthmatics in the US, another 15 million with severe to moderate COPD that would dramatically benefit from adherence technology,” Anderson said. “We’re talking about 40 million patients that are potential targets. The US market is huge. And we’ve got a handful of companies that are looking at going and demonstrating how adherence can change that outcome. Frankly, it’s good for all of us that there are multiple companies involved in that.”
Asthma patients can now get relief after knowing their health is being taken care of by being monitored by a device. The sensor will also inform patients when to use it by either making a sound, vibrating or lighting up.
Clinicians will even get more information on how the patient is using the device, whether they are misusing it by holding it upside down or they use it at the wrong time. It will bridge the gap between, a patient visiting the hospital or by a specialist to their next check-up where all information needed is stored in the form of data.
Image credit: www.youtube.com