• Mediware Information Systems (Lenexa, Kansas), a provider of healthcare delivery and patient safety software management solutions, said it has submitted its next-generation hospital donor management system, HCLL Donor, to the FDA for 510(k) clearance. Frank Poggio, vice president and general manager of Mediware's Blood Bank Division, said, "We have designed HCLL Donor to build upon and extend the foundation of the advanced HCLL Transfusion system. We expect HCLL Donor to have the same substantial positive impact on customer operations as the HCLL Transfusion system."

• MultiCell Technologies (Warwick, Rhode Island) said that its majority owned subsidiary, Xenogenics, has been granted U.S. patent No. 6,858,146 on its Sybiol synthetic bio-liver device. The patent includes more than 40 claims to the device and methods for its use in the purification of a patient's bodily fluids. Xenogenic's synthetic bio-liver device was re-designed to use the company's immortalized human liver cells lines. The Sybiol bio-liver is an extracorporeal device designed to support patients who are waiting for liver transplants, who are suffering from episodic liver disease caused by hepatitis, alcoholism, cancer or from burn or toxic shock syndrome or other liver trauma. The device is designed to increase not only life spans, but also the quality of life in afflicted patients. The Sybiol device is intended to operate optimally with MultiCell's immortalized hepatocytes.

• Neoprobe (Dublin, Ohio) said the FDA has accepted its request to establish a corporate investigational new drug (IND) application for Lymphoseek. With the establishment of the corporate IND, responsibility for the clinical and commercial development of Lymphoseek has been officially transferred from the University of California, San Diego (UCSD) to Neoprobe. Lymphoseek is intended to be used in biopsy procedures for the detection of lymph nodes in a variety of tumor types including breast, melanoma, prostate, gastric and colon cancers. In connection with the transfer of responsibility for the Lymphoseek IND from UCSD to Neoprobe, the FDA has provided guidance suggesting it be evaluated in a multi-center clinical study to confirm the findings observed by the UCSD researchers. That initial multi-center trial would then be followed by a confirmatory Phase III study using the final cGMP material. Neoprobe said it intends to commence enrollment in the first of the two multi-institutional studies as soon as the appropriate regulatory and institutional review board clearances are received.

• PLUS Orthopedics USA (San Diego) reported the availability of its PiGalileo Navigation System to be used with its TC-PLUS Solution knee to optimize the results of total knee replacement surgery. The PiGalileo Computer-Assisted Orthopedic Surgery System combines computer-assisted surgery technology and mechanized instrument positioning technologies to assist the surgeon in total knee replacement procedures. Surgeries done with PiGalileo are performed by a surgeon, with mechanized technologies aiding in instrument positioning. The company said the technology provides intra-operative feedback to the surgeon to help improve precision, thereby potentially leading to better implant alignment and positioning. PLUS Orthopedics USA is a wholly owned subsidiary of PLUS Orthopedics Holding AG.

• Reality Engineering (Vancouver, Washington) is introducing at the Chicago Dental Society midwinter meeting MedVisor/dental, a patient education and communication tool that translates highly technical details and procedures into easy-to-understand 3-D dental animations. MedVisor/dental debuts this week.

• Restore Medical (St. Paul, Minnesota) said that its Pillar Palatal Implant System has received CE mark certification for obstructive sleep apnea (OSA) and is now cleared for use in Europe. Unlike surgical treatments, the Pillar Procedure is performed in a single office visit using local anesthetic, and is completely reversible. The procedure places three small inserts in the patient's soft palate located at the back of the roof of the mouth. The procedure stiffens the palate, preventing or lessening blockages of the airway – effectively treating sleep apnea and substantially reducing the intensity of snoring in most individuals.

• Rochester Medical (Stewartville, Minnesota) reported the market introduction of its Closed System Intermittent Catheter in both Hydrophilic Intermittent and Antibacterial Hydrophilic Intermittent configurations. The Closed System packages the intermittent catheter with pre-lubricated insertion tip inside a collection bag that permits "touch free" sterile use. The Closed System is first being introduced in the U.S. where, according to industry estimates, such systems account for as much as 30% of domestic intermittent catheter sales. The Hydrophilic and Antibacterial Hydro Closed System Intermittent Catheters are available as single units or in kits that include gloves, antiseptic wipes, and underpad. Rochester Medical manufactures latex-free disposable medical catheters and devices for urological and continence care applications, marketed under its own Rochester Medical brand and under private-label arrangements.

• Sangart (San Diego), a developer of oxygen transport agents, reported the completion of patient enrollment in its Phase II clinical trial involving Hemospan (MP4), a hemoglobin-based oxygen carrier designed to serve as an alternative for blood transfusions. The trial was conducted at six major medical centers in Sweden and involved 90 patients undergoing elective and emergency orthopedic surgeries. Sangart said it expects to receive data and results from the study over the next few months. Preclinical and clinical studies indicate that Hemospan is free of harmful vasoactivity and provides targeted oxygen delivery to tissues at risk of oxygen deprivation.