FDAnews Device Daily Bulletin

Bioject Medical Technologies, a developer of needle-free drug delivery systems, has entered into a supply agreement with Chronimed, a specialty pharmacy that distributes pharmaceuticals and provides specialized patient management services for people with HIV/AIDS.

Cardiovascular Systems has received marketing clearance from the FDA for the company's Orbital Atherectomy System used to remove tissue causing stenosis in synthetic AV shunts.

Delphi Medical Systems has signed an exclusive distribution agreement of Delphi's IVantage infusion pumps with Fresenius Kabi.

BioElectronics, a developer and marketer of disposable, drug-free medical devices, has announced that its ActiPatch Therapy product is in clinical trials with a major pharmaceutical foot care company.

Avitar has entered into a Standby Equity Distribution Agreement with Cornell Capital Partners, LP. Under the deal, signed as of Feb. 1, 2005, Cornell Capital is committed to provide up to $10 million of equity financing which can be drawn by the company in $250,000 tranches at any time over a 24-month period, subject to certain conditions and obligations.

Zimmer Holdings has acquired U.S. distribution rights for the Palacos line of bone cement products manufactured by Heraeus Kulzer of Germany, a developer and producer of orthopedic bone cement products and other healthcare technologies.

Vertebron has announced the release of its first structural allograft, the Vertebron PLF Allograft System, its third system release.

Align Technology, the inventor of Invisalign, a proprietary method of straightening teeth without wires and brackets, has filed a multiclaim lawsuit in San Francisco County Superior Court against defendants OrthoClear, OrthoClear Holdings, Muhammad Ziaullah Chishti, Bao Tran, Peter Riepenhausen, Joe Breeland, Jeff Tunnell, Christopher Kawaja and Charles Wen. Among other things, the lawsuit alleges tortious and illegal actions arising out of defendants' plan to unlawfully utilize Align's intellectual property, confidential information and employees.

BioGenex Laboratories has received the premarket approval from FDA for its InSite Her-2/neu Kit. This in vitro diagnostic kit is used to identify breast cancer patients eligible for treatment with the cancer drug Herceptin (Trastuzumab).

Cambridge Consultants has designed an intelligent radio transceiver architecture that introduces a new level of power economy and performance for in-body medical diagnostic and therapeutic applications.

Eastman Kodak has formed an alliance with TUV Rheinland of North America to provide regulatory compliance and testing services to Kodak and other companies worldwide.

Laboratory Corporation of America (LabCorp) has completed its previously announced acquisition of U.S. Pathology Labs, a provider of anatomic pathology and oncology testing services with a focus on the outpatient market.