Category: Device News
Device specific news; Announcements, reports, reviews and device specific news
Masimo Corp. sees positive results for its pleth variability index technology published in Anesthesia & Analgesia.
Masimo Corp. (NDSQ:MASI) announced positive results for its pleth variability index technology in monitoring patients during and after surgery.
The Irvine, Calif.-based company said patients monitored with its PVI device had improved fluid management and lower lactate levels, compared to those managed by standard care without PVI technology, in a randomized trial.
Quidel Corp. wins Food & Drug Administration 510(k) clearance for its chorionic gonadotropin-based pregnancy test.
Quidel Corp. (NSDQ:QDEL) landed a nod from the Food & Drug Administration for its new pregnancy test platform.
The RapidVue dipstick-format pregnancy immunoassay will be the San Diego-based diagnostics company's fourth product launched this year, according to a press release.
Quidel designed the human chorionic gonadotropin-based test to be used with urine samples. The company said test results are available three minutes after use.
Lawsuits continue to pile up for Johnson & Johnson's DePuy Orthopedics division over its ASR hip implant, with the latest accusing the company of knowingly selling a defective product.
Less than a week after its recall of a pair of hip implants, DePuy Orthopaedics was hit with another series of lawsuits over the devices, this time alleging that the Johnson & Johnson (NYSE:JNJ) subsidiary knowingly sold defective products.
Warsaw, Ind.-based DePuy pulled its ASR hip replacement system off the market last week after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.
InfraReDx Inc. lands 510(k) clearance from the Food & Drug Administration for its LipiScan IVUS near-infrared spectroscopy and intravascular ultrasound-based coronary imaging system.
The Food & Drug Administration gave InfraReDx Inc. 510(k) clearance for the company's LipiScan IVUS coronary imaging system.
The device employs both so-called "near-infrared" spectroscopy and intravascular ultrasound technology to give cardiologists a grayscale IVUS image of a coronary artery, along with a map of lipid core coronary plaques within a blood vessel.
A study by the American Heart Assn. shows that African-American individuals have more than double the risk of other races for blood clots after receiving drug-coated stents.
African-Americans have double the risk for blood clots after being treated with drug-eluting stents, according to a a study published in Circulation: Journal of the American Heart Assn.
In as few as 30 days, race was the strongest predictor for clotting after stents were implanted, the study showed.
The researchers analyzed data from 7,236 patients who, between mid-2003 through 2008, were treated with stents coated with clot-prevention drugs.
Medical device start-up Hotspur Technologies Inc. wins three 510(k) clearances from the Food & Drug Administration after two years in business and a relatively small amount of funding — $5.5 million over two rounds.
Two-year-old Hotspur Technologies Inc. landed three Food & Drug Administration clearances in less than four months, all with the relatively modest backing of $5.5 million.
The Mountain View, Calif.-based company, which was incorporated in 2008, claimed its first three 510(k)s, one in 90 days and two more in 110 days.
pSivida Corp. and Alimera Sciences win priority review status for their Iluvien drug/device combination, designed to treat diabetic macular degeneration.
The Food & Drug Administration put pSivida Corp. (NSDQ:PSDV) and Alimera Sciences Inc. (NSDQ:ALIM) on the fast track, granting an expedited review for their drug/device combination designed to treat diabetic macular edema.
Watertown, Mass.-based pSivida and Alpharetta, Ga.-based Alimera filed a new drug application with the FDA in June for Iluvien, a sustained release drug delivery system that delivers flucocinolone acetonide, a steroid, for the treatment of DME.
