…can be implanted without surgery.
It’s an age of miracles, if the government doesn’t screw it up.
One thought on “The World’s Smallest Pacemaker”
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…can be implanted without surgery.
It’s an age of miracles, if the government doesn’t screw it up.
Comments are closed.
They already have.
In 2012 the FDA determined that all pacemakers had to go through the PMA process and were no longer eligible for 510k clearance. Why do you think that Nanostim chose the CE Mark-first regulatory pathway? The CE Mark process is predictable and small, innovative companies can raise capital on that. Once the European approval is in place, the company becomes eligible to be gobbled up by a big fish with the resources to dance in the FDA minefield. The Europeans have the Nanostim leadless pacemaker today. If we’re lucky, St. Jude will navigate the PMA process and the U.S. will have sales of Nanostim in the next 5-10 years.