HealthBeacon Obtains FDA Clearance for the World’s First Smart Sharps Adherence Device

Digital Therapeutic company HealthBeacon receives 510K FDA clearance to provide smart sharps bins to US patients

(Dublin, Ireland; Boston, MA) HealthBeacon, a digital therapeutic innovator, announced today that they have received clearance by the United States Food and Drug Administration (FDA) to offer the HealthBeacon smart sharps bin to patients using injectable medications in the US.

HealthBeacon’s injectable adherence platform has been cleared by the FDA, and will be available for the first time to the millions of Americans on long term, chronic injectable care. HealthBeacon anticipates the US commercial launch of its platform later this summer.

Since launching commercially in Europe, in 2013, HealthBeacon currently serves thousands of patients across 10 markets in Canada, Europe, the Middle East and South America.

HealthBeacon CEO, Jim Joyce, has stated, “Working with the FDA over the last year, and ultimately receiving FDA clearance is a defining moment for HealthBeacon as a company. We are excited to launch in the US later this summer.”

The digital therapeutic market has reached significant landmarks in the last year, and HealthBeacon joins a small but elite number of digital therapeutic organizations with validated technology that have received FDA clearance.

Robert K. Coughlin, President and CEO of MassBio has commented, “I am delighted to hear HealthBeacon has received FDA Clearance for their novel medical technology, and has chosen Boston to launch their U.S. operations. There is no better place in the world for the life sciences, and we’re thrilled to welcome a company that will bring further value to the healthcare system and to patients.”

Dublin, Ireland based HealthBeacon has strong ties to the US, as it is founded by Irish-American and native Bostonian Jim Joyce. This connection has strengthened since opening their first US based office in Boston in March of 2017.

This clearance is part of HealthBeacon’s regulatory strategy to make its technology available globally. This follows on HealthBeacon’s recent announcement of approval for the Brazilian market.

About HealthBeacon

HealthBeacon is a Digital Therapeutics company that develops smart tools for managing medication. HealthBeacon has developed an injectable medication management system that tightly monitors patients digitally, keeping them adherent to their prescription and leveraging real time data to drive clinical intervention. This system has been clinically reviewed, validated by the pharmaceutical industry and has been integrated into patient care programs throughout North America and Europe, delivering valuable data to both the patient and their clinical team.