Product briefs: PinPoint to unveil new locator system

PinPoint (Bedford, Massachusetts) has unveiled a new technology allowing hospitals and other facilities to precisely monitor the movement and location of people and equipment. Dubbed a Local Positioning System, PinPoint's 3D-ID technology provides precise monitoring of indoor spaces by means of small radio tags that permit long-range detection, even through walls, the tracking range varying from 100 feet or more for most applications up to 1,000 feet for some. Those requiring location include newborn babies and key staff members, with the electronic tags capable of replacing the traditional hospital bracelet or being integrated into a hospital badge. Besides indicating location, the tags can be programmed to trigger alarms if someone leaves a designated zone or, say, a newborn is taken from a nursery. The alarm feature also could be used to ensure that babies move only with specified "friends," such as parents or hospital personnel. Besides securing infants, the system also could enable nurses, doctors, and even orderlies to determine not only where the patient is, but also where that patient has been, said Armando Viteri, PinPoint president. Important equipment to be tagged might include wheelchairs and mobile X-ray machines. The patent-pending 3D-ID system is based on what is called "pseudonoise" research conducted by the . Department of Defense. Its core technology is a Tag Tracking Network composed of cell con-trollers and antennas which continuously monitor thousands of tags as they move through a facility. Asset Tracking Network software, built on an open client/server model, collects and processes the infor-mation in a form compatible with existing computer systems, the company says.
Beta tested at a New York hospital, the system was unveiled at the Scantech exhibition in Chicago last month. PinPoint recently acquired $8 million in capital to support pilot production by the end of the year and deliveries in 1999. Elsewhere in the product pipeline: * Angeion (Minneapolis, Minnesota) has received FDA premarket approval for . marketing of its Sentinel Series of implantable cardioverter defibrillators (ICDs). The Sentinel Series includes four ICDs - Models 2000, 2010, 2011 and 2012 - along with the AngeFlex lead system, ICD programming system and external defibrillation test system. Angeion's ASEC dual-battery system uses battery chemistry and capacity for up to 10 years of device longevity. Addi-tional features include the Small Cap Biphasic Wave- form and programmable Hot Can electrode to lower defibrillation thresholds. * Bio Medical Disposal (Norcross, Georgia) has received FDA approval for its Sharpx Needle Destruc-tion Unit, a portable device which destroys 19 gauge to 27 gauge hypodermic needles, 1/2 inch to 2 inches in length. Intended for use in both out-patient and in-patient treatment settings and clinical laboratories, the system uses a rechargeable volt NiCad battery to deliver a current between two electrodes, incinerat-ing the needle and capturing the debris in a replace-able aluminum-lined drawer. The needle debris is then emptied into a sharps disposal container. The company is currently accepting orders for the device and will begin shipments in the fourth quarter. * Biolase Technology (San Clemente, California) has launched its LazerSmile home tooth-whitening system. The company said the system will be avail-able in dentists' offices. Biolase makes and sells laser-based cosmetic, dermatological and surgical systems. * Cappelen Laboratory Technics (Roskilde, Den-mark) has developed a low-cost, hand-held microplate washer available for either 96- or 384-well microplates. The CAPPwash uses a two-in-one washing pin design and is fully autoclavable. * CardioDynamics International (San Diego, California) launched its recently FDA-cleared Thoracic Electrical Bioimpedance monitor at the 20th Congress of the European Society of Car-diology in Vienna, Austria, in August. The company calls it the smallest such monitor, and it features an integrated battery and non-invasive blood pressure module, which can be incorporated into a majority of health care information systems. CardioDynamics said orders for the system already have been received from two of the firm's European distributors, Levi Medica (Rome) and Ho-Med (Vienna). * Closure Medical (Raleigh, North Carolina) has received FDA approval to market its Dermabond (1) Topical Skin Adhesive, used to replace sutures, sta-ples and adhesive strips for closing topical incisions and lacerations. It is the first product of its type to be approved for the . market and was granted approval under the FDA's expedited processing sys-tem. The product will be entered into a worldwide market constituting about 90 million procedures thus far using sutures and staples, and totaling about $ billion annually. The product was approved for use on simple, superficial wounds that are easily closed, thoroughly cleansed and not infected. Closure in 1996 licensed exclusive worldwide marketing and distrib-ution rights for the product to Ethicon (Somerville, New Jersey), a subsidiary of Johnson & Johnson, and last year received CE Mark approval for marketing in the European Union. * CryoLife (Marietta, Georgia) has commenced European marketing of its BioGlue surgical adhesive for repairing aortic dissections. BioGlue's two main components are bovine albumin and glutaraldehyde which crosslink when mixed to form an adhesive strong enough for use in major blood vessels such as the aorta. BioGlue received the CE Mark in January this year and will start FDA-approved clinical trials in the . soon. * Dade Behring (Liederbach, Germany) has launched an ultrasensitive latex slide test for C-reac-tive protein (CRP), the new NLatex CRPmono with a total measurement range from - 1000mg/L. With-in the CRP decision range of 2 - 4mg/L, the new assay provides high reliability with a CV of .8%. * Datascope (Montvale, New Jersey) has received the CE Mark for its VasoSeal ES second-generation arterial puncture sealing device for commercializa-tion in the European Union. VasoSeal seals arterial puncture wounds created for angiography, balloon angioplasty and stent procedures in interventional cardiology and radiology. Datascope said shipments are scheduled to begin the fourth quarter. * Diesse Diagnostica Senese (Siena, Italy) has launched in Europe the Syphilis Fast latex agglutina-tion slide test, which can replace both VDRL and TPHA combination tests. The test is claimed to show high specificity and sensitivity at all stages of infec-tion, including primary stage with specific IgM. * Dornier Medizintechnik (Geimering, Ger-many) has received FDA approval for the Urowave portable and compact microwave thermotherapy device for the treatment of benign prostatic hyperpla-sia. The Urowave device has a urethral therapy probe which allows 360-degree cooling and which can deliver up to 90 watts of power to the tissue. * Ethicon Endo-Surgery (Cincinnati, Ohio) has released its LCS-5 (LaparoSonic Coagulating Shears), an addition to its line of Harmonic Scalpel products. This 5mm version of the LCS system gives surgeons the ability to use ultrasonic shears through smaller incisions. The device features a complete 360-degree rotating blade and clamp arm with an ergonomic design allowing the surgeon to approach the targeted tissue from any point and angle. It may be used for a variety of videoscopic procedures, such as Nissen fundoplication for gastroesophageal reflux disease, laparoscopically assisted hysterectomy, cholecystecto-my, excision of endometrial implants, lysis of adhe-sions and myomectomy. Ethicon is a Johnson & Johnson company. * Greiner (Frickenhausen, Germany), in coopera-tion with Bayer, has developed a new 1,536-well microplate which fulfills the requirements of fully auto-mated systems. A well volume of 12 microliters allows bioassays and cell-based assays to be carried out. * Guidant (Indianapolis, Indiana) has announced worldwide market release of its Vasoview Uniport Endoscopic Vessel Harvesting System, which enables rapid, atraumatic harvesting of the saphenous vein for use in coronary artery bypass (CABG) surgery. The sys-tem requires only a single, 2cm incision and is the least invasive endoscopic vessel harvesting system currently available for cardiac surgeons and physician assistants, according to the company. Features include in-line instrumentation, operating through a single, multi-lumen cannula for fewer wound complications, reduced pain, accelerated recovery time and improved cosmetics. * IDL Biotech (Sollentuna, Sweden) has devel-oped two urinary bladder cancer assays - a quantita-tive monoclonal UBC (urinary bladder cancer) ELISA test in microplate format and the IDeal Rapid UBC test, which is a one-step immunochromatographic assay using the same monoclonal antibodies as the ELISA test. The Rapid UBC test is suitable for self-testing by patients and is intended for regular use after surgery or therapy to give early warning of any recurrence. * Imaging Diagnostic Systems (Fort Lauderdale, Florida) has submitted the first series of 20 total in vivo human images from its breast-imaging device to the FDA. The images were captured during Phase I clinical trials of the device. The system uses laser tech-nology and computer algorithms to create contiguous cross-sectional images of the breast without breast compression or X-rays. The company said it will next begin Phase II trials with about 400 participants. * KeraVision (Fremont, California) has filed a premarket approval application for its treatment to correct myopia by altering the corneal curvature in a 15-minute procedure that laces a pair of clear polymer inlays in the eyes. Patients have the option of chang-ing or removing the inlays, which the company calls the KeraVision Ring. * Laserscope ( San Jose, California) has received FDA clearance to market its KTP-based Orion 800 Series and High-Power 800 Series Laser Systems for treating benign prostatic hyperplasia, a non-cancer-ous enlargement of the prostate. The company said it expects to introduce the High-Power 800 Series in 1999 as a field upgrade module on certain models of its 800 Series systems. * Mallinckrodt (St Louis, Missouri) and Molecu-lar Biosystems (San Diego, California) have been granted the CE Mark for their ultrasound cardiac imaging agent, Optison. Initial launches will be in Austria, Germany and the United Kingdom, with other countries following as price structures are approved. Optison already has FDA clearance and is on the . market. * Maxxon (Tulsa, Oklahoma) has introduced its Safety Syringe to the purchasing office of the Swedish government, with the goal of encouraging that coun-try to incorporate the product into its national health-care system. The Safety Syringe uses a patented sys-tem for automatically retracting the needle into the plunger after use to avoid needlestick injuries. * Mikura (Colchester, England) has launched in Europe a compact modular design microplate washer range which can be configured to suit individual needs. All fluid pathways can be demounted and are autoclavable. * Northfield Laboratories (Evanston, Illinois), in cooperation with Pharmacia & Upjohn (Bridgewater, New Jersey), is the latest . company to enter clini-cal trials in Europe with its PolyHeme blood substi-tute. Northfield Laboratories said that trials will be on trauma patients in Germany, Sweden and the Unit-ed Kingdom. Trial data arising will be used together with data from . trials in European regulatory approval submissions. * OrthoLogic (Tempe, Arizona) has filed supple-mentary documents with the FDA for pre-market approval of its SpinaLogic-1000, designed to stimu-late spinal fusion. The supplement is based on the original application, approved for the OL-1000 bone growth stimulator and it uses the same combined magnetic field technology of that system. OrthoLogic specializes in non-invasive therapeutic devices to stimulate the healing of damaged or degenerated bone, cartilage and ligaments. * Possis Medical (Minneapolis, Minnesota) has filed a premarket approval application with the FDA to use its AngioJet Rheolytic Thrombectomy System to remove blood clots from coronary blood vessels. The company said it had requested that the FDA give expedited review status to its PMA. * Premier Laser Systems (Irvine, California) has received FDA marketing clearance for its Pegasus Nd:YAG laser used to remove the coronal pulp in pulpotomies and as an adjunct to root canal proce-dures. Traditionally, cleaning and shaping of the pul-pal cavity in endodontic procedures is performed using reamers and files or rotary instruments. The dental laser is expected to make these procedures cleaner and more comfortable for the patient. * QLT PhotoTherapeutics (Vancouver, Canada) has received expanded FDA approval for its light- activated drug Photofrin for use as a treatment for advanced lung cancer and reduction of endobronchial tumor obstruction, adding to its use for treating advanced esophageal cancers. The treatment uses lasers made by Laserscope, with the laser beam activating the light-activated drug at the tumor site to destroy dis-eased tissues. The treatment is limited to applications for certain early-stage lung cancers in patients who aren't candidates for surgery and radiotherapy. * Synthetic Blood International (SBI; Kettering, Ohio) has received a notice of allowance from the . patent office for claims covering the use of various per-fluorocarbons as a blood gas exchange media. "Improv-ed Perflurocarbon for Biological Gas Exchange" covers uses for the company's proprietary perfluorocarbons in blood substitutes and liquid ventilation products and also claims the use of dual perfluorocarbons with different boiling points in liquid ventilation to control exhalation and pulmonary persistence. SBI holds 13 patents covering perfluorocarbons and is developing Oxycyte, a blood substitute emulsion, and Fluorovent, a perfluorocarbon liquid ventilation product. * Thermo Cardiosystems (Woburn, Massachu-setts) has received a notice of compliance from the Med-ical Devices Bureau of Health Canada for commercial-ization in that country of the company's HeartMate left ventricular-assist system. The approval allows the com-pany to sell both the pneumatic and electric versions of its heart-assist device throughout Canada. The Heart-Mate is implanted alongside the natural heart in order to take over the pumping function of the left ventricle for patients whose hearts are too damaged or diseased to produce adequate blood flow. The company also supplies whole-blood coagulation testing equipment and related disposables, as well as single-use skin-inci- sion devices. Thermo Cardiosystems is a subsidiary of Thermedics, a Thermo Electron company. * Toshiba America Medical Systems (Tustin, Cal-ifornia) has announced development of multi-slice computed tomography technology for faster, more accurate imaging procedures. The system increases the volume and acquisition speed of CT imaging by using a four-slice, multi-detector, with a one-half sec-ond ratio. This delivers eight slices per second, while also reducing dose reduction to the patient. Chuck Corogenes, director of Toshiba America's CT business unit, said that the company developed "multi-slice CT not only to enhance the scanning efficiency of routine studies, but also to expand clinical applications for greater system utility." With faster acquisition of clini-cal data, the greater scanning efficiency offers more uniform enhancement of an entire region and the thin-ner .5mm slices provide improved throughput. * Transmedica (Little Rock, Arkansas) has re-ceived a letter of allowance from the . Patent Office that it will receive a patent for the use of lasers in drawing capillary blood and for the transdermal administration of pharmaceuticals. The patent covers the company's Laser Lancet, which has already received device patent protection and has been cleared by the FDA for all capillary blood draws for screening purposes. The Laser Lancet is manufactured for Trans-medica by LaBarge (St. Louis, Missouri). * Uni-Cath (Miami, Florida) has received the CE Mark for its IRIS coronary stent products, including the IRIS Stent and the VISA II Coronary Balloon Catheters. The IRIS stent features moderate flexibility, uniform expansion and strong radial force with little recoil, and the VISA II Coronary Balloon features superior pushability and flexibility.