The FDA released a flurry of recalls for medical devices this week.
First, iCad Inc. (NSDQ:ICAD), formerly Xoft Inc., had to remove a radiation guard for breast cancer treatment, over reports that the device sheds tungsten particles.
The FDA issued the Class I recall for Sunnyvale, Calif.-based company’s Axxent FlexiShield Mini, Model F5300. The Food & Drug Administration issues Class I recalls when there is potential for serious injury or death from use of a particular device or product.
InVivo Therapeutics Holdings Corp. (OTC:NVIV), which raised close to $12 million when it went public last year, reported a $9 million net loss for the year ending Dec. 31.
The Cambridge, Mass.-based startup, which is developing an implantable treatment of acute spinal chord injuries, said the 260 percent increase in net losses was attributable to “a non-cash charge of $5,099,000 for derivative losses.” Since its inception in 2005, Invivo has lost more than $14.2 million.
Xoft Inc. could turn out to be a lot more expensive for iCad (NSDQ:ICAD) than the $1 million in cash and the 8.47 million shares of stock it paid for the oncology device manufacturer late last year.
General Electric Co.’s (NYSE:GE) healthcare unit closed its takeover of Clarient Inc. through a short-form merger in a $5-per-share cash deal worth about $587 million. GE’s buyout of the cancer diagnostic company is part of its strategy to grow is disease-diagnosis business, according to the company.
iCAD (NSDQ:ICAD) signed an agreement to purchase X-ray technology developer Xoft Inc.
The Nashua, N.H.-based medical imaging company expects the $13.1 million acquisition to close by the end of the year.
The deal is comprised of about 8.47 million shares of iCAD common stock, or 15.6 percent of iCAD’s outstanding common shares, and $1 million in cash.
Federal regulators cleared a new device for U.S. sales that produces three-dimensional images of the colon, specifically identifying polyps and other suspicious tissue that can be an early sign of cancer.
Nashua, N.H.-based iCAD Inc. (NSDQ:ICAD) developed the system, called the VeraLook, and already markets similar computer-aided detection equipment for breast and prostate cancers.
The Veralook had previously been approved for sale in Europe and Canada and 510(k) clearance by the U.S. Food & Drug Administration has been quietly anticipated for some time inside the company.
iCAD, Inc. (NSDQ:ICAD) posted a 6.4 percent increase in second-quarter sales and narrowed its net losses by 47.4 percent.
The Nashua, N.H.-based firm, which makes CAD software for cancer detection systems, reported net losses of $736,000, or 2 cents per share, on sales of $6.1 million during the three months ended June 30. That compares with net losses of $1.4 million, or 3 cents per share, on sales of $5.7 million during the same period last year.
iCAD Inc. (NSDQ:ICAD) won a contract with the U.S. Defense and Veterans Affairs departments to sell its cancer detection devices to the 400 treatment facilities under the agencies’ auspices.
The Nashua, N.H.-based company, which designs image analysis equipment for the early identification of cancer, entered the agreement with the Defense Supply Center to provide federal healthcare facilities, including Veteran’s Administration and Dept. of Defense hospitals with its computer-aided mammography technology for.
Net losses at iCad Inc. (NSDQ:ICAD) widened during the first three months of 2010, as the medical imaging and software company saw revenues slip 9.7 percent from year-ago levels.
The Nashua, N.H.-based company reported a net loss of $1.2 million, or 3 cents per share, on $6.5 million in revenues during the three months ended March 31. That compares with a $1 million net loss, or 2 cents per share, on $7.5 million in revenues during the first quarter of 2009.