• Criticare Systems (Milwaukee) reported the introduction of a proprietary Neonatal product line consisting of Incubators and related accessories in corroboration with a premier designer and manufacturer of infant focused products. The company is launching these products at an International distribution conference, this week in Asia, hosted by, and exclusive to Criticare. The neonatal line will be initially marketed throughout Criticare’s existing International distributor network with future consideration for U.S. exposure. Criticare makes patient monitoring systems.

• Fluidigm (South San Francisco) has achieved a first in microfluidics — a matrix chip architecture that enables both a high density of experiments (2,304 per chip) and effective mixing of nano-volume scale fluids. This new chip will allow Fluidigm to enter end-point PCR detection markets, such as SNP genotyping, which require both high-throughput and fully mixed reaction components. Reagent is loaded into a microchannel and contained by valves, in effect, as a “reagent slug” . These containment valves then open to allow sample to be introduced into the same channel in contact with the slug. Fluidigm specializes in integrated fluidic circuits.

• LifeCell (Branchburg, New Jersey) said it has received FDA clearance for Strattice tissue matrix, a novel soft tissue repair product. Like AlloDerm, the company’s flagship reconstructive surgical product, Strattice is intended for use in soft tissue repair procedures including breast reconstruction and hernia repair. In preparation for commercial launch, the company is planning to initiate several clinical studies. LifeCell makes tissue repair products for use in reconstructive, orthopedic and urogynecologic surgical procedures.

• LeMaitre Vascular (Burlington, Massachusetts) reported the first implant in the UNITE clinical trial of its UniFit abdominal stent graft. The study will evaluate the safety and effectiveness of the company’s UniFit abdominal stent graft in the treatment of aorto, aorto-iliac, and/or iliac aneurysms. The primary effectiveness endpoint of the study is based on aneurysm exclusion as evaluated through one- year follow-up. The UNITE study compares the safety and efficacy of the UniFit against open surgical abdominal aorta repair, because there are currently no aorto-uni-iliac endovascular stent grafts indicated for this use. The device’s encapsulated design minimizes the extent to which its stents contact the blood stream or the vessel wall. This design also allows a wider range of stent graft sizes, including tapered and custom grafts, to fit a wider range of patient anatomies than many competing products. LeMaitre Vascular makes devices for the treatment of peripheral vascular disease.

• Memry (New York) reported the launch of Putnam Plastics Plus, a new product line offered by the company’s Putnam polymer division, which is focused exclusively on secondary operations solutions for medical polymer tubing. With a variety of secondary operations support and capabilities, PPC+ offers dedicated support in areas such as tipping/welding, hole drilling, custom grinding, precision cutting, pad printing, product assembly and flaring. Memry makes material components to the medical device industry.

• SonoSite (Bothell, Washington) reported that its SonoMB imaging advance is now available on its curved array probes, thereby extending this valuable technology to a broad range of exam types. The company began customer shipments of new MicroMaxx systems incorporating the SonoMB technology early this week. It is available as a software upgrade at no charge to existing MicroMaxx customers. SonoMB technology is a proprietary SonoSite imaging algorithm that improves contrast resolution and reduces ultrasound artifact while providing exceptional frame rates and superior image quality for the clinician. The result is increased resolution in both the near and far field, finer definition of small structures and improved visualization of physiology and subtle tissue differences. SonoSite makes hand-carried ultrasound.

• Younger America (Fort Lauderdale, Florida) reported that the company’s wholly owned subsidiary, Life Without Pain (Clearwater, Florida), has a pain therapy process applying its Medlight MD630PRO. This process uses a light emitting diode (LED) for pain therapy. Relying on narrow band near infrared energy, the Medlight is able to temporarily relieve minor aches and pains, such as arthritis, joint pain, muscle spasms, or relaxing stiff and sore muscles. Based on the NASA-developed LED technology, the Medlight offers Life Without Pain’s 81 LED array in a lightweight and AC-powered device. Younger America is a holding company that develops and acquires companies that provide products to improve the quality of life without the use of potentially harmful drugs or chemicals.

No Comments