Mela Sciences CEO Joseph Gulfo tells MassDevice about the path from nearly assured clearance in June 2009 to the brink of clearance more than two years later.
Former Medtronic CEO Bill Hawkins, in an exclusive interview with MassDevice.com, tells us about the one that got away: Guidant Corp.'s stent-making operation.

There's no shortage of ink spilled over the feeding frenzy over Guidant Corp., which ended in Boston Scientific Corp.'s (NYSE:BSX) ill-fated $26 billion acquisition in 2006. But there's one nugget from the spectacle that hasn't received much attention.
The prelude to...
Seasoned patent attorney David Dykeman takes us through the America Invents Act in a podcast interview highlighting the challenges and opportunities the reform bill poses for the medical device industry.
This week President Barack Obama is expected to sign a patent reform bill marking the most dramatic changes to the patent system in decades, drawing adulation and ire from varying sectors of the innovation economy.
The American Invents Act, six years in the making, contains several sweeping changes, but the main bone of contention is a transformation of the U.S. patent system from a first-to-invent application process to a first-to-file process.
...Boston Scientific makes a generational move in choosing Johnson & Johnson executive Michael Mahoney, but who is the 46-year-old medical device veteran?
Neuronetics president & CEO Bruce Shook on treating an incurable psychiatric disorder, chasing reimbursement and turning psychiatrists into medical device proceduralists.

Neuronetics Inc. is paving the way for a new type of depression therapy, a non-invasive electromagnetic field treatment designed to stimulate brain cells linked to depression.
Bruce Shook, co-founder, president & CEO, talked to MassDevice about pioneering the market for the only FDA-cleared transcranial magnetic stimulation system to date, his company's NeuroStar TMS system...
Former Medtronic CEO Bill Hawkins, in the second installment of an in-depth interview with MassDevice.com, gives us an inside look at one of the most high-profile medical device recalls ever – the Sprint Fidelis pacemaker lead.

In October 2007 Bill Hawkins was only three months into his tenure as CEO of the world's largest pure-play medical device maker when he faced the toughest choice of his career – cancel shipment on the company's top product, the Sprint Fidelis pacemaker lead, already implanted in some 268,000 patients – or stand pat and keep the...