SynapDx to commence autism Dx trials in early 2013
SynapDx plans to begin clinical trials early next year for a blood test that could lead to the early detection of autism.
NanoString Cancer Dx passes second large-scale test
NanoString Technologies says a second clinical validation trial looking at whether its new breast cancer diagnostic test could accurately gauge the risk of recurrence for a particular kind of breast cancer generated robust results with a high degree of accuracy. That good news, the company adds, will form the basis of its FDA regulatory submission for the assay (though it remains coy as to when that will be). Read more >>
ImmunoCellular taps Andrew Gengos to serve as president
> After less than two years on the job, Namal Nawana resigned as president of DePuy Synthes Spine to pursue opportunities outside Johnson & Johnson ($JNJ), Mass Device reports. Nawana took the position in March 2011 after serving J&J and the DePuy Family of Companies for 13 years in roles in engineering, marketing, sales and general management. Worldwide Marketing Vice President Max Reinhardt will succeed Nawana as president. The division blended DePuy with Synthes after J&J's $21.3 billion acquisition closed earlier this year. Story
> Endosense called upon Nicolas Marsault to serve as CFO. Marsault most recently worked at Merck Serono. Release
> EOS Imaging named Michael J. Dormer chairman of the board of directors. Dormer served as head of Johnson & Johnson Medical Devices and Diagnostics. Release
Click here for more hirings and firings throughout the industry >>
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Cardiosonic seeks $16.1M for renal denervation tech
Israeli startup Cardiosonic has pulled in $6.1 million of a planned $16.1 million Series B, aiming to fund the development of its ultrasound-based renal denervation device, Tivus.
Boston Scientific rolls out updated SCS chronic pain implant in Europe
The use of spinal cord stimulation (SCS) to treat chronic pain is a growing area in the device world, and Boston Scientific ($BSX) is moving to claim a larger piece of the action in Europe. Its latest move: a new CE mark for its updated Precision Spectra SCS system to address a broad class of patients with chronic pain.
Medtronic pays dividend early to beat possible tax changes
With the looming fiscal cliff, it's anyone's guess how taxes on dividends may change come 2013, so Medtronic is serving up a Christmas gift to its shareholders, issuing January's dividend ahead of schedule.
FDA wants PMA, not 510(k), for Abiomed's Impella
An FDA panel voted to keep temporary ventricular support devices such as Abiomed's Impella under the Class III device designation, which, under a new set of rules, means they will need to file full PMAs even if they're already cleared.
Wright Therapy raises $3M Series B for home-use pneumatic compression devices
Devicemaker Wright Therapy Products attracted a $3 million Series B financing round in a venture deal that reflects the current industry investment focus on stability, approved products and cost-effective care.
First U.S. patient tests DBS device for Alzheimer's
Functional Neuromodulation's deep-brain stimulation device has been implanted into its first U.S. Alzheimer's patient--the first surgery of its kind here.
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What started out three months ago as a single-lot recall of pain meds that Endo Health Solutions ($ENDP) said might exceed their size limits has turned into a recall of 101 lots, some of them shipped two months after the initial yellow flag was waved.
In September, the generics subsidiary of Endo Health Solutions voluntarily recalled one lot of two pain drugs that it called "super potent" because both exceeded their prescribed weights. Now Endo has added 100 more lots to that removal.
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