Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
Pre-Market Approval (PMA)
The Food & Drug Administration released a list of pre-market approvals granted in October:
A report in the Archives of Internal Medicine is drawing a lot of buzz from its comparison of Class I recalls for devices cleared via 510(k) or via pre-market approval.
Nearly three-quarters of Class I medical device recalls went through the Food & Drug Administration’s 510(k) pre-market notification process from 2005 to 2009, according to a report in the Archives of Internal Medicine.
That’s proof that high-risk devices should not be cleared for market using the quicker and less stringent 510(k) process, the authors claim, arguing that the devices should instead be reviewed via the more rigorous — and costly — pre-market approval program. Class I recalls, the most serious level, are issued for devices that could cause serious injury or death.
The plant inspection must have gone well, because the Food & Drug Administration approved Hologic Corp.’s (NSDQ:HOLX) one-of-a-kind 3d breast imaging platform, the Selenia, for performing mammograms.
The Food & Drug Administration approved Medtronic Inc.’s (NYSE:MDT) MRI-safe pacemaker, touted as the first such device to hit the market.
The Minneapolis-based medical device giant said it plans to begin shipping the product immediately.