After a year of negotiations, the medical device industry and the FDA signed off on a tentative agreement for the next 5 years of med-tech user fees, nearly doubling the industry’s expected buy-in and setting some "game-changing" expectations for the agency.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Toshiba lands 510(k) for latest Aquilon CT scanner | Regulatory Roundup
Toshiba’s (TYO:6502) American medical products division won 510(k) clearance from the FDA for the latest iteration in its Aquilon line of CT scanners.
The Aquilon Prime is designed for healthcare facilities that need to perform a wide variety of advanced clinical examinations with reduced radiation exposure, according to a press release.
FLASH: Device makers agree to double user fees
The medical device industry and the FDA came to a tentative agreement on reauthorizing the Medical Device User Fee & Modernization Act – for double the price.
Although negotiations seemed stagnant and the agency quietly missed its Jan. 15 deadline to submit a proposal to Congress, the two sides announced a preliminary accord today that would double user fees over the next 5 years, to $595 million.
Is robotic surgery worth the price? | MassDevice.com On Call
MASSDEVICE ON CALL — Complication rates for women with endometrial cancer were roughly the same after standard laparoscopy and robot-assisted surgery, although the robotic procedures each cost about $1,300 more, according to a study in the Journal of Clinical Oncology.
MassDevice.com +3 | The top 3 med-tech stories for January 30, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
Medtronic lands FDA clearance, plans launch for next-gen CRM lead | Regulatory Roundup
Medtronic Inc. (NYSE:MDT) landed FDA clearance for its DF4 high-voltage right ventricular lead for use with implantable cardiac rhythm management devices.
The DF4, which builds on Medtronic’s Sprint Quattro lead, aims to help simplify the implantation process with a redesigned port and by providing visual confirmation of the lead’s connection to the device.
FDA staffers sue agency over email surveillance
Six of the so-called "FDA 9" whistleblowers are suing the federal watchdog agency, alleging that the government violated their constitutional rights with surveillance of their private email accounts.
The staffers allege that the FDA spied on the private email accounts they accessed using their government-issued computers, after they warned Congress and the president that unsafe medical devices were being allowed onto the U.S. market.
MassDevice.com +7 | The top 7 med-tech stories for the week of January 23, 2012
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else this weekend, make sure you’re still in the know with MassDevice +7.
Illumina launches “poison pill” against Roche’s takeover bid | MassDevice.com On Call
MASSDEVICE ON CALL —Illumina’s (NSDQ:ILMN) board of directors adopted a "poison pill" strategy in response to a hostile takeover bid by Roche (PINK:RHHBY).
Illumina adopted a rights agreement which allows shareholders other than the a bidder to buy additional shares at a discounted price, potentially deterring would-be bidders by increasing costs.
Thoratec settles Oracle beef | Wall Street Beat
Thoratec Corp. (NSDQ:THOR) said it reached an agreement with one of its major institutional shareholders, Oracle Investment Management, over whether or not the heart pump maker should hire an investment bank to find a buyer.
Greenwich, Conn.-based Oracle, which holds a 5.2% stake in the heart pump maker, recommended that Thoratec retain an investment bank to explore strategic alternatives, including sale to a larger company.
FDA’s medical device ombudsman details complaints
The ombudsman’s office for the FDA’s medical device arm released details of the contacts it had with the public last year, including complaints about the watchdog agency’s reviews of medical technology.
The Center for Devices & Radiological Health’s ombudsman said there were 461 new contacts in 2011, 11% more than during the prior year. The contacts included questions, requests for clarification, or issues that don’t rise to the level of a complaint or a dispute.