FDAnews Device Daily Bulletin

ZOLL Medical announced the results of two clinical studies that were completed in out-of-hospital settings that provide evidence that the ZOLL AutoPulse Noninvasive Cardiac Support Pump helps to increase short-term survival in cardiac arrest patients.

Initial results of a study with a bioabsorbable metal stent show that the novel device works as intended -- to prop open blocked leg arteries before being fully absorbed into the artery wall, so that complications common with standard stents don't occur.

Philips announced that it will offer the HeartStart OnSite Defibrillator for sale without a prescription.

SurModics, a provider of surface modification and drug delivery technologies to the medical device industry, has acquired InnoRx, a drug delivery company developing novel therapies for the ophthalmology market.

BioGenex Laboratories has won approval from federal regulators to sell a diagnostic kit that would help doctors determine which breast cancer patients are eligible for treatment with the Genentech drug Herceptin.

Dade Behring and Inpeco, a global supplier of automation technology solutions, have announced that they have signed a memo of understanding designed to solidify their long-term partnership in laboratory automation.

Acacia Research has announced its CombiMatrix group has entered into a distribution agreement with InBio to distribute CombiMatrix's CustomArray microarray products for the Australian and New Zealand marketplaces.

Merit Medical Systems, a manufacturer and marketer of proprietary disposable products used primarily in cardiology and radiology procedures, has announced the release of its First Step prep kit.

CHF Solutions, a privately held medical device manufacturer, has completed a $22.9 million offering of its convertible, preferred stock.

Medical imaging products maker CTI Molecular Imaging has reported that its CTI Mirada Solutions unit received clearance from the FDA to market its Scenium software to compare brain scans.

Vapotherm, a privately held manufacturer of respiratory care devices for hospital and home care use, has announced that the European Patent Office (EPO) has given notice that it intends to grant a European patent on Vapotherm's patient delivery tube system.

Spire has announced that Spire Biomedical, its wholly owned subsidiary, has been awarded a three-year contract to offer its dialysis catheter products to Premier hospitals.

Hydrogel Design Systems, a subsidiary of Nesco Industries, is in the process of completing the first order under a supply agreement with Vyteris signed on Dec. 27, 2004.

Synovis has announced publication of data showing that using Peri-Strips, the company's biomaterial buttress, to reinforce the staple line during laparoscopic gastric bypass surgery reduced the possibility of acute staple-line failure and gastrointestinal leakage.