Edwards Lifesciences (NYSE:EW) said the FDA set a date for its circulatory devices advisory panel to review a pre-market approval application for its Sapien heart valve.
Pre-Market Approval (PMA)
Dune Medical lands FDA panel date for MarginProbe breast cancer device
Dune Medical Devices has a date with the FDA to review its pre-market approval application for the MarginProbe breast cancer detection device.
The watchdog agency’s general & plastic surgery devices advisory panel scheduled a hearing for June 21 to review the PMA data for the device, which uses electromagnetic waves to characterize human tissue in real time and "provides intra-operative information on the malignancy of the surface of the ex vivo lumpectomy specimen," according to the FDA.
GAO: FDA “inconsistent” in meeting performance goals
The FDA lacks consistency in review times for medical device pre-market approval applications, missing most goals for submissions marked "expedited," according to report by the Government Accountability Office.
"For FYs 2003 through 2010, FDA met most of the goals for original PMAs but fell short on most of the goals for expedited PMAs," according to the GAO report. "In addition, FDA review time and time to final decision for both types of PMAs generally increased during this period."
Zoll wins FDA nod for EMS AED | Regulatory Roundup
Zoll Medical (NSDQ:ZOLL) said it won 510(k) clearance from the for its ZOLL X monitor/defibrillator, a smaller, more powerful device aimed at the EMS market.
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HeartWare lands FDA OK for extended trial ahead of PMA review | Regulatory Roundup
Cameron Health’s FDA date is good news for Boston Scientific
Cameron Health landed an April date with the FDA’s circulatory devices panel to review a pre-market approval application for its lead-free subcutaneous implantable cardioverter defibrillator, or S-ICD.
The S-ICD system, unlike traditional ICDs, sits just beneath the skin and does not rely on wires relayed through blood vessels and connected to the heart in order to provide heart rhythm therapy.
Sanuwave takes its dermaPace foot ulcer treatment back to trials
Regenerative medicine firm Sanuwave Health (OTC:SNWV) will run another clinical trial of its dermaPace foot ulcer treatment, after the FDA determined that its initial pre-market approval bid failed to meet its primary endpoint.
New trials may take up to 2 years before the company re-submits its device for FDA review, according to a press release.
FDA releases January PMA approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.