Medtronic Inc. (NYSE:MDT) CEO William “Bill” Hawkins reacted positively to changes the Food & Drug Administration announced today for its 510(k) program, calling them a “positive sign” that regulators are open to working more collaboratively with industry but denying that the medical device industry won a round in the fight against stricter regulation.
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Zyga wins FDA clearance for spinal fusion device
Spinal tools company Zyga Technology Inc. received Food & Drug Administration 5100(k) clearance for its SImmetry Sacroiliac Joint Fusion System.
The device is designed for minimally invasive surgery to eliminate lower back pain by stabilizing the sacrum — vertebrae at the base of the spine which connect the spine to the pelvis.
Boston Scientific to pick up Atritech for up to $375 million
Boston Scientific Corp. (NSYE:BSX) agreed to acquire Plymouth, Minn.-based Atritech Inc. for $100 million in cash plus milestone payments of up to $275 million more through 2015.
Atritech’s CE Mark-approved Watchman device is designed to close the left atrial appendage in patients with atrial fibrillation who are at risk for ischemic stroke.
Stryker Biotech, execs blast back at feds
Calling it a threat that "has the potential to swallow completely the attorney-client privilege," lawyers for former Stryker Biotech chief Mark Philip fired back at federal prosecutors in a criminal case alleging the illegal promotion of bone putties.
Healthcare lawsuit swells to 26 states
MASSDEVICE ON CALL — Healthcare lawsuit swells to 26 states. Six more states said Tuesday they would join the lawsuit in Florida over the healthcare reform legislation’s individual mandate, meaning more than half of the country will challenge the law, reports the Associated Press.
Study: U.S. medtech industry’s lead shrinking
The U.S. is quickly losing ground to emerging markets in medical technology innovation, according to a new study from PricewaterhouseCoopers.
"The nature of innovation is changing as developing nations become the leading markets for smaller, faster, more affordable devices that enable delivery of care anywhere and help bend the cost curve downward," PwC wrote in its latest Medical Technology Innovation Scorecard.
Quintiles layoffs consistent with CRO industry
Quintiles is laying off workers again. The Durham, North Carolina-based clinical research organization is laying off workers in a "small employee action," according to LocalTechWire.
Quintiles, a privately held company, isn’t disclosing how many workers were affected, nor will it say where the cuts were made. Quintiles also didn’t say much last May when the company confirmed layoffs throughout the company.
Quintiles is the industry’s largest CRO with annual revenue topping $3 billion and more than 20,000 workers employed wordwide.
Burning beds warning letter poses Invacare long-term pain
For most medical device companies, the occasional warning letter from the Food & Drug Administration is just a minor annoyance, another part of doing business.
The FDA letters, which are published on the agency’s website, typically cite failures in record-keeping and manufacturing processes that are quickly corrected by companies and forgotten by everyone else.
FDA 510(k) changes drop tomorrow
The Food & Drug Administration’s Center for Devices and Radiological Health will release its proposed changes for the 510(k) regulatory pathway for medical devices, President Barack Obama revealed today.
In an opinion piece for The Wall Street Journal, on how to make U.S.’s regulatory systems more efficient, Obama included one sentence regarding the the process for which 2,654 new medical devices were cleared for market last year.
NeoChord pulls in $1 million in preparation for European approval
NeoChord Inc., which is developing innovative medical devices for the heart’s mitral valve, raised $1 million to tide it over before a larger fund-raise and European regulatory approval.
The Minnetonka, Minn.-based company is about one-third of the way through clinical trials in Europe testing its first device, which supplies artificial chordae tendineae — the thread-like tissues that anchor the leaflets of the mitral valve to heart muscle. Surgeons using NeoChord’s technology can implant the artificial chords with a probe-like device through a small incision in the chest.
FDA device branch: Complaints surge, disputes cut in half
The Food & Drug Administration’s Center for Devices and Radiological Health saw 29 percent increase in complaints last year, logging a record high of 171 in 2010.
The surge in complaints is less dramatic than the 45 percent increase the agency saw from 2009 to 2010, but the number of contacts, comprised of complaints, disputes and inquiries the agency fielded rose from 250 to 414, up 66 percent.