Anita Finnegan: “The FDA published a cybersecurity guidance document that outlined requirements for medical device manufacturers.”

The idea of a malevolent individual hacking a critical medical device may sound like the stuff of crime fiction, but it is well within the realms of p(...)

SecuRetract founder Conor O’Shea: his retractor, due to go on sale the start of 2017, is aimed at laparoscopic surgeons worldwide

Conor O’Shea is a postgraduate researcher at UCC with a penchant for invention. An engineer by training, O’Shea has come up with a new design for the (...)

Attendees at the Consumer Electronics Show in Las Vegas. Photograph: Gregory Bull/AP

Slendertone has brought its ab-toning belt into the connected age with a Bluetooth version that connects to your smartphone. The electric muscle sti(...)

Neonatal EEG device cuts time needed to fit sensors to a baby’s head from an hour to two minutes, and it can be done by any member of the nursing staff on the ward

When Jim Roche attended his first workshop with Enterprise Ireland, he didn’t have a fledgling business plan to bring with him. The founder of medical(...)

AstraZeneca chief executive Pascal Soriot: ‘This acquisition complements our strategic focus on cardiovascular and metabolic disease.’ Photograph: Simon Dawson/Bloomberg

Britain’s AstraZeneca has agreed to buy US biotech company ZS Pharma for $2.7 billion, pipping Swiss firm Actelion to the prize in the latest bout of (...)

Mainstay Medical chief executive  Peter Crosby estimates that there is a potential market for its device of more than two million people in the US and Europe. Photograph: Nick Bradshaw

Irish company Mainstay Medical will seek regulatory approval in Europe for its chronic lower back pain device following clinical trial results that co(...)

The drug could cost women as much as $400 per month

Valeant Pharmaceuticals agreed to pay about $1 billion (€895 million) in cash for Sprout Pharmaceuticals, the US pharmaceutical group that this week r(...)

The drug flibanserin, which is marketed under the trade name Addyi, nicknamed “female Viagra”.

It has been dubbed the “female Viagra” and this week it became the first drug for treating loss of libido in women to win approval in the US. The deci(...)

The drug flibanserin, under the trade name Addyi, nicknamed “female Viagra” is shown in this undated Sprout Pharmaceuticals handout photograph released on Tuesday. Photograph: Sprout Pharmaceuticals/Reuters.

The first drug to treat low sexual desire in women won approval from US health regulators on Tuesday, but with a warning about potentially dangerous l(...)

Without FDA approval, no drug or medical device can access what is by some distance the world’s largest market for pharma and medtech. Photograph: Roel Smart/Getty Images/iStockphoto

In what was truly a case of David vs Goliath, Irish pharma minnow Amarin comprehensively saw off the might of the US drug regulator, the Food and Drug(...)