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.
The FDA’s real record on medical device recalls
FDA pitches 33 percent budget boost
It’s time once again for the annual Beltway Budget Brouhaha and the Food & Drug Administration is wading right in with a request for a 33 percent boost.
Study casts safety doubts on most FDA-cleared medical devices
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.
FDA approves Hologic’s Selenia 3D mammography system
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.
FDA recalls Arstasis arterial access device
The Food & Drug Administration issued a recall for Arstasis Inc.’s arterial access device.
Components of the Redwood City, Calif.-based company’s One Access System could fracture or separate during surgical procedures, which could lead to patient harm, according to the watchdog agency.
The device is designed to provide surgical access to blood vessels in femoral artery catheterization procedures. It also assists care providers in stopping the bleeding involved in the procedure, the FDA said.
VIDEO: Shuren on the FDA’s new innovation track
On Feb. 8, The Food & Drug Administration unveiled a new, fast-track protocol for breakthrough medical technologies this week, saying its new “Innovation Pathway” aims to speed high-tech devices to market.
Medtronic wins FDA nod for MRI-safe pacemaker
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.
FDA’s “Innovation Pathway” proposal débuts with military bionic arm project
The Food & Drug Administration, aiming to blaze trail on a so-called "Innovation Pathway" designed to speed innovative medical technology to market, tapped a military project to create a prosthetic arm controlled by a brain-implanted microchip as its first speedy review candidate.
Merit Medical, American Regent issue recalls
Merit Medical Systems Inc. (NSDQ:MMSI) and American Regents Inc. both issued recalls.
Merit told its customers to immediately stop using one of the company’s vascular catheter sheaths.
The South Jordan, Utah-based company’s Prelude catheter introducer’s tip may detach during use, a failure that could allow the part to enter the bloodstream, according to the Food & Drug Administration.
ConforMIS wins FDA 510(k) clearance for custom knee implant
ConforMIS Inc. won 510(k) clearance from the Food & Drug Administration for its custom knee implant system, the iTotal CR.
Unlike standard implants, iTotal CR devices are based on an individual’s CT scans and tailored for their knee bones using computer-aided design.
Standard implants come in six or seven different sizes, meaning that surgeons must measure a patient’s bones after an incision to select the best fit, according to ConforMIS founder and CEO Philipp Lang.
Study: European regulatory regime just as safe as FDA’s
The medical device industry is touting a study it says debunks the Food & Drug Administration’s claims that there’s a safety benefit from the slower, more rigorous regulatory process in the U.S.
The conclusions are based on a new study, paid for by the Advanced Medical Technology Assn., that compares four years of recall data from U.S. and EU regulatory bodies.
The study, “EU Medical Device Approval Safety Assessment,” conducted by the Boston Consulting Group, matched four years of medical device recall data for the United Kingdom, Germany, Switzerland and Ireland and compared it with similar U.S. data. The report’s authors conclude that there is no material difference between the regulatory regimes in the U.S. and Europe, from a safety perspective.
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