A Food & Drug Administration advisory panel recommended that the watchdog agency tighten restrictions on drugs used during MRI scans for patients with severe kidney disease, because the contrast agents have been linked to a rare but often crippling or deadly disease called nephrogenic systemic fibrosis, according to news reports.
The Food & Drug Administration told hospital administrators across the country to stop using a popular endoscope sterilizer made by Steris Corp. (NYSE:STE) within six months, after the watchdog agency could not verify the safety of the product.
The Steris System 1 processor is typically used in surgical and endoscope suites for sterilizing and disinfecting medical devices.
Peter Nicholas is scheduled to deliver 102,722 shares of his Boston Scientific Corp. (NYSE:BSX) stock to an unidentified commercial bank today, making good on his end of a year-old transaction and completing another step in liquidating a $72 million stake in the company he helped launch.
A relative bantam is stepping into the patent infringement ring with one of the industry’s heavyweights.
Medgraph Inc., a Rochester, N.Y.-based telemedicine firm, sued Medtronic Inc. (NYSE:MDT), accusing the Minneapolis medical device monolith of patent infringement for its Carelink diabetes management system.
The Food & Drug Administration issued a Class I recall of a Stryker Corp. (NYSE:SYK) computer-aided surgery platform, saying the device can suddenly go dead during procedures.
The Kalamazoo, Mich.-based surgical device maker initiated its own Class I recall of 23 of its Navigation System II devices Nov. 4. No injuries were reported as a result of the software glitch, which can cause the system to shut down or screens to freeze or slow down during surgeries. FDA’s move means it views the problem as potentially life-threatening or capable of causing serious injury.
Microsoft Corp. (NSDQ:MSFT) agreed to acquire Sentillion Inc., a health information technology provider based in Andover, Mass., for an undisclosed amount.
Sentillion makes context and access management software used by more than 1,000 hospitals. Microsoft plans to integrate the technology into its Amalga Unified Intelligence System.
The Redmond, Wash.-based software conglomerate said the deal will enable it to streamline access to multiple IT applications and patient data, regardless of whether they are Web-based, Windows-based or legacy systems.
Analogic Corp. (NSDQ:ALOG) posted lower sales and earnings during the first quarter, but its medical technology business clawed its way toward last year’s levels. Analogic also settled a dispute with an activist investor group and inked a new deal for its security business.
The Peabody, Mass.-based imaging equipment maker posted sales of $95.4 million for the three months ended Oct. 31, down 6.1 percent compared with $101.6 million during the same period last year. Net income plummeted 91.9 percent to $26 million, from $320 million during Q1 2009.
Boston Scientific Corp. (NYSE: BSX) wasted no time in looking to capitalize on its escape from the junkyard, at least in the eyes of one rating agency.
Standard & Poor’s Ratings Services raised BSX’s credit rating out of junk bond status, freeing BSX up to raise some cash in an effort to pay down a massive chunk of debt that comes due in April, 2011.
To that end the company put out a bond prospectus, seeking to raise $2 billion through the sale of senior unsecured notes.
Echo Therapeutics Inc. (OTC:ECTE) is gearing up for a push to land new investors next year, which it expects to be “transformative,” hiring a New York-based investor relations consulting firm to manage a “strategic investor relations campaign.”
Hayden IR will develop and implement the Franklin, Mass.-based company’s bid to attract more investors in 2010. Echo is developing needle-free drug delivery technologies, including a non-invasive, wireless glucose monitoring device and skin preparation system for transdermal drug delivery.
Medtronic Inc. (NYSE:MDT) said California attorney general Jerry Brown is demanding documents from its cardiac rhythm management business, making Brown the second AG this year to subpoena the Minneapolis medical device monolith.
Medtronic said Brown wants documents “relating to the Company’s cardiac rhythm medical devices, including revenue, sales, marketing and promotional documents,” according to a regulatory filing. The Golden State’s top legal eagle also wants reimbursement records, clinical trial data and registration information and records of any payments “or items of value” to customers. Brown sent the subpoena Sept. 16, according to the filing.
AdvanDx won 510(k) clearance from the Food & Drug Administration for a rapid diagnostic designed to detect staphylococcal pathogens in the bloodstream in 90 minutes.
The Woburn, Mass.-based diagnostics maker said the FDA cleared its S. aureus PNA FISH and S. aureus/CNS PNA FISH tests, claiming they cut down turn-around times by an hour by reducing probe hybridization times. Staph bacteria are the most prevalent cause of bloodstream infections and blood culture contamination, according to the company.