The Adherium Ltd (ASX: ADR) share price soared to dizzying heights today. This comes after the digital healthcare company announced it has received a 510(k) clearance from the United States Food and Drug Administration (FDA).

At the end of Thursday's market close, Adherium shares finished up 53.33% to 2.3 cents.

Milestone achievement for Adherium

The Adherium share price surged today as investors were fighting to get a hold of the company's shares.

According to its release, Adherium advised that the United States FDA has cleared the pathway for the company to begin commercialisation for Hailie Sensor.

The company's next generation, Hailie Sensor are devices that attach to a patient's Asthma or Chronic Obstructive Pulmonary Disease (COPD) medication inhaler. This allows caregivers to monitor medication use and capture clinical data whilst supporting the patient's management and treatment journey.

Furthermore, the latest Hailie Sensor is designed for use with AstraZeneca's Symbicort aerosol inhaler.

The total addressable market for treating Asthma and COPD patients in the United States is estimated to be around US$1.5 billion.

With the Hailie Sensor approved, this means that the FDA has granted 10 510(k) licences to Adherium for its devices. As such, the company has become a market leader in respiratory digital health.

Adherium stated that it intends to pursue multiple channels in order for Hailie Sensor to enter the market.

Adherium CEO, Rick Legleiter commented:

The FDA's first clearance of our next generation Hailie sensors with physiological measures is a significant regulatory step for the business.

The stage is now set for physiological measures to be coupled with our existing adherence sensor capability giving us the total 'one-two punch' to deliver the best value proposition of any smart inhaler digital solution in the world.

…Adherium will expand its addressable respiratory medication market coverage and establish a preeminent business partnering position for providers, payors and digital health affiliates.

About the Adherium share price

Since this time last year, Adherium shares were mostly tracking lower until today, currently down 22%. Year-to-date, its shares are also in negative territory, down 14%.

Adherium presides a market capitalisation of roughly $54.3 million and has 2.1 billion shares on its registry.

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