• Fresenius Medical Care(Bad Homburg, Germany), a provider of dialysis products and services, reported that it has received FDA 510(k) clearance for an advanced device to be used by patients who perform dialysis in the home setting. The Liberty Cycler is designed for use in automated peritoneal dialysis therapy, which Fresenius said is the fastest-growing home therapy for the treatment of end-stage renal disease. The Liberty Cycler combines advanced pumping technology with ease of use, according to the company.

• ImaRx Therapeutics (Tucson, Arizona) said the first patient has been treated in a Phase I/II clinical trial evaluating the safety and efficacy of SonoLysis for the treatment of peripheral arterial occlusive disease (PAOD). SonoLysis, which combines external ultrasound and ImaRx’s nanobubbles, is designed to clear blood clots quickly and without the use of invasive surgery or potentially dangerous lytic drugs. In this 12-patient, multi-center trial, six patients will receive a 60-minute treatment of SonoLysis (nanobubbles and ultrasound), while the remaining six will receive SonoLysis in conjunction with a small bolus of tPA, a lytic agent that is typically administered to dissolve the blood clots that cause PAOD.

• Mediscience Technology (Cherry Hill, New Jersey) said that it is in development of an adjunctive instrument, called the Cancer Detection Map (CD-Map), to facilitate the acquisition of fluorescence images from surgical breast specimens following lumpectomies and surgical procedures. The instrument will be used to define the margins of tumors at the point-of-care, allowing the physician to achieve clear margins in real time during cancer surgery without the use of invasive agents. The CD-Map is highly sensitive and can acquire images in less than one second. Zoom capability allows the CD-Map to acquire images over an area that can vary from sub-centimeters to several centimeters with a resolution better than 100 mm. The CD-Map is a UV/visible fluorescence imaging system designed to gain image emission from native fluorophors in tissue. A tunable light source and movable filters permit the acquisition of images at multiple combinations of emission and excitation wavelengths. Intensity ratio maps are computer generated from the fluorescence images and either the intensity images or pseudo-color ratio images are displayed.

• Novadaq Technologies (Toronto) said that data on a 106-patient randomized clinical trial of its Spy Intra-operative Imaging System was presented at this week’s American Association for Thoracic Surgery meeting in San Francisco. The study was designed to compare the diagnostic accuracy of two competing technologies that verify the quality of bypass grafts constructed during coronary artery bypass surgery. Intra-operative graft angiography with the Spy System involves intravascular administration of fluorescent indocyanine green dye and visualization of the graft with dispersed laser light. Transit Time Ultrasound Flow Measurement (TTF), the most commonly used form of intra-operative graft quality verification, uses an intra-operative ultrasound probe to measure flow value and pattern. In the study, 139 bypass grafts were examined with the Spy System and TTF. The primary endpoint was to compare the ability of each system to correctly identify grafts with problems using standard X-ray angiography as the “gold standard.” The study showed the Spy System demonstrated superior diagnostic accuracy and was able to correctly identify 58% more bypass grafts with technical problems than TTF, the company reported.

SmartPill (Buffalo, New York), developer of the SmartPill Capsule, a non-invasive, ingestible device that captures biomedical data from within a patient’s GI tract, reported that 510(k) clinical trials of its SmartPill ACT-I Capsule and GI Monitoring System are set to begin at Wake Forest University Baptist Medical Center (Winston-Salem, North Carolina) next week, bringing to three the number of sites participating in the SmartPill clinical trial. A total of 25 subjects, 15 of whom are healthy and 10 who have been documented with gastroparesis (the inability of the stomach to empty) are expected to participate in the study. The primary objective of the study is to demonstrate the correlation between the gastric residence times measured by the SmartPill ACT-I Capsule and by the ingestion of a radio-labeled meal and scintigraphic images.

• Thomas Scientific (Swedesboro, New Jersey), a distributor of scientific equipment, instrumentation, chemicals and supply items, reported the release of its new Mini Centrifuge. Requiring less than six inches of bench space, the Thomas Mini Centrifuge is a personal-size unit for microfiltration and quick spin downs from the walls and caps of microcentrifuge tubes. Mini Centrifuge is supplied with easy-to-interchange standard microtube and strip rotors and adapters to accommodate 0.4 mL, 0.5 mL and 1.5 mL tubes as well as 0.2 mL strips and individual tubes. An easy-to-open translucent lid features a durable stainless steel hinge pin. The on/off switch is located on the side of the Mini Centrifuge, with the switch in the “on” position; the centrifuge can be started and stopped by closing and opening the lid.

• Whatman (Florham Park, New Jersey), a leader in separations technology, reported the launch of the EasyClone 384 plate, a single, versatile device to replace the existing workflows currently used by genomics institutes and laboratories. The EasyClone 384 plate can be used for the archiving, shipping and purifying of clones - all at room temperature. Customers can now use integrated biosample management systems from GenVault (San Diego) to manage the EasyClone 384 plates. GenVault’s systems provide compact stacking and storage of thousands of plates as well as easy access to individual samples through robotic automation and complimentary software. The company said EasyClone 384 provides a simple way of storing clone samples and eliminates the need for current storage back-up methods and facilities that ultimately rely on power supplies.