Medical device industry titan Medtronic (NYSE:MDT) filed a bid for FDA approval of its MiniMedR 530G system, which the company bills as the world’s first insulin pump that delivers and halts insulin automatically, based on sensor readings of a patient’s glucose levels.
Pre-Market Approval (PMA)
Boston Scientific’s Innova peripheral stent débuts in Europe | Regulatory Roundup
Boston Scientific (NYSE:BSX) said it plans to get its Innova stent for peripheral artery disease on the market in the European Union "immediately" now that it’s won CE Mark approval there.
Biotronik touts FDA approval for next-gen heart devices at HRS 2012 | Regulatory Roundup
Boston Scientific wins FDA nod for latest pacemaker set
Boston Scientific (NYSE:BSX) said the FDA approved the latest set of its pacemakers, including a device designed to treat patients who can’t regulate their heartbeats while exercising.
The Natick, Mass.-based med-tech maker said the watchdog agency granted pre-market approval for its Ingenio and Advantio pacemakers and for its Invive cardiac resynchronization therapy pacer.
FDA clears Ethicon’s 1st surgical set docs can assemble inside the body | Regulatory Roundup
Johnson & Johnson (NYSE:JNJ) Ethicon Endo-Surgery won FDA clearance for the 1st surgical instruments that can be assembled and disassembled inside the body during surgery.
Four medical implants that escaped FDA scrutiny
by Lena Groeger, ProPublica
BSX ticks up on positive panel vote for Cameron S-ICD
Another heart device won a nod from an FDA advisory panel yesterday when Cameron Health’s subcutaneous implantable cardiac defibrillator won rave reviews from the committee, sending Boston Scientific (NYSE:BSX) shares up a tick today on Wall Street
Boston Scientific wins PMA for Epic stent
Boston Scientific (NYSE:BSX) won pre-market approval from the FDA for its Epic self-expanding iliac stent.
The watchdog agency approved the device for treating de novo or restenotic symptomatic atherosclerotic lesions in the iliac arteries, according to agency documents released today.
HeartWare wins FDA panel nod
An FDA advisory panel recommended approval for HeartWare International‘s (NSDQ:HTWR) HVAD implantable heart pump for people with end-stage heart failure.
The watchdog agency’s circulatory devices panel said the agency should approve the left ventricular assist device for use as a so-called "bridge to transplant" for patients waiting for a heart transplant.
NASDAQ halts trading in HeartWare shares ahead of FDA panel vote
Early indications that the FDA is likely to approve an implantable heart pump made by HeartWare International (NSDQ:HTWR) pushed its shares up nearly 7% this week, prompting the NASDAQ stock exchange to halt trading of the shares today as an agency panel considers the company’s pre-market approval application.
FDA releases February PMAs
The FDA’s Center for Devices ^& Radiological Health released the details on the pre-market approval applications it OK’d in February:
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.