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FDA approves first interactive digital inhaler sensor

The FDA has given its first approval to an interactive digital inhaler sensor that allows patients to manage their condition by providing instructions and recording usage data.

Young girl with CapMedic inhaler

CapMedic's interactive interface helps patients as young as five years of age to use inhalers correctly (credit: Cognita).

The first interactive digital inhaler sensor has been approved by the US Food and Drug Administration (FDA). The drug delivery system can be used in the treatment of asthma, Chronic Obstructive Pulmonary Disease (COPD) and other pulmonary conditions.

The product… uses artificial intelligence (AI) powered sensor technology to provide precisely timed instructions”

The inhaler fuses digital technology with traditional Metered Dose Inhalers (MDIs), which guides patients using live audio-visual cues to help them use the device correctly and regularly, crucial for effective therapy and avoidance of flare-ups.

According to Cognita Labs, which developed the product, the approval marks the only FDA-cleared wireless technology that allows users to track the progression of their lung health through an in-built spirometer; this measures lung parameters Forced Expiratory Volume in one second (FEV1) and Peak Expiratory Flow (PEF).

The product, named CapMedic, uses artificial intelligence (AI) powered sensor technology to provide precisely timed instructions to patients. Medication and lung function data can be transferred to the smartphone app which can help patients to manage their condition and aid in Remote Patient Monitoring (RPM).

“Decades of studies have shown that almost 90 percent of patients are unable to use MDIs correctly – a result of their complex, multi-step usage requirements. The Cognita team has conducted drug deposition studies showing a tenfold improvement in the delivery of medication from just four to five percent to 45 percent when inhalers are used correctly,” said Dr Rajoshi Biswas, Chief Scientific Officer and co-founder at Cognita Labs. “Getting an effective daily dose means patients are more likely to avoid costly, life-threatening hospitalisations.”

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