Breakthrough US FDA approval for Irish medtech firm HealthBeacon

24 May 2018

HealthBeacon CEO Jim Joyce with one of the company’s machines. Image: HealthBeacon

Coveted FDA approval status opens up entire US market for HealthBeacon.

HealthBeacon, the maker of a revolutionary new digital way for people to take medication safely, has achieved clearance from the US Food and Drugs Administration (FDA) for its technology. This status is much sought after by medtech players across the world.

HealthBeacon’s Smart Sharps System helps patients adhere to their medication schedule. The digital platform not only ensures that patients keep up with their injectable treatments, but also allows them to dispose of medication in a safe way and keeps carers up to date with the patients’ progress.

In effect, this move sets the stage for an Irish company to sell to a market worth billions of dollars.

HealthBeacon’s injectable adherence platform will be available for the first time to the millions of Americans on long-term, chronic injectable care.

The use of HealthBeacon smart technology aims to make a dramatic impact to cost savings within the US healthcare industry. Current estimated costs to manage medication non-adherence are estimated to be $290bn in the US market alone.

HealthBeacon anticipates the US commercial launch of its platform later this summer.

‘Med’ in Ireland

The machine is made in Ireland and the company has strong ties to the US since it was founded by Irish-American and native Bostonian Jim Joyce who originally came to Ireland to work with a US pharma FDI company located here.

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 last year revealed plans to create 20 new jobs in Dublin in roles spanning IT, software development, project management and customer service, to bring its headcount close to 40 people.

The company also opened offices in Boston last year to pave the way for its North American expansion.

Speaking with, Joyce said that the approval by the FDA comes after years of hard work.

“We would not have been able to commercialise our product in the US until we achieved this vital FDA clearance.

“Now, every home where there is medical waste, whereby people require specific, injectable medication, could be a customer of ours because, with this approval, they have opportunities to be reimbursed by insurance companies.

“Our visibility in the US will now improve greatly and we plan to do a major launch in Chicago in July. Everything is going to plan,” said Joyce.

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

Robert K Coughlin, president and CEO of life sciences cluster Massachusetts Biotechnology Council (MassBio), said: “I am delighted to hear HealthBeacon has received FDA clearance for their novel medical technology, and has chosen Boston to launch their US 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.”

John Kennedy is a journalist who served as editor of Silicon Republic for 17 years