Medgadget

My Lab One Portable Ultrasound from Esaote Makes Debut

Thu, 19 Nov 2009 00:46:33 -0800

At the ongoing Medica 2009 in Düsseldorf, Esaote out of Genoa, Italy is releasing a new portable ultrasound system that features a 12 inch touch screen for manipulating settings without having to use buttons. The My Lab One can be worn on a shoulder strap and is designed for mobile applications such as ambulatory anesthesia, EMT, military and sports medicine.

From the press release:

The automatic rotation of the image according to the position of the system, an ergonomic probe equipped with controls, a long life battery, all add up to making this ultrasound an extraordinary innovation in the medical system arena.
MyLab One is a “dedicated” ultrasound, which reflects perfectly today’s need for diagnostic capabilities in many different fields of application: from Radiology to Cardiology, from to Orthopaedics, Anaesthesia, Sports Medicine, etc… or in first-aid, emergency, vascular screening as well as in general practices.

Press release: Esaote presents “My Lab One” Innovative “wearable” ultrasound scanner ARM HELD

Product page: Esaote ultrasound...

Covidien Announces Global Launch of Mallinckrodt TaperGuard Line of ETTubes

Wed, 21 Oct 2009 12:02:40 -0800

Anesthesiologists, EMTs and other intubators, rejoice! Covidien has just announced the world wide release of a new line of endotracheal tubes called Mallinckrodt™ TaperGuard™. Designed to "substantially" reduce the risk of microaspirations thanks to its taper-shaped cuff, the tubes come in two models: TaperGuard™ and TaperGuard™ Evac (shown in the picture).

More details in the press release...

Product page: TaperGuard...

GE's New Ultra Small Ultrasound May Become as Ubiquitous as Stethoscope

Wed, 21 Oct 2009 00:50:51 -0800

Yesterday at the Web 2.0 Summit in San Francisco, GE showed off their new handheld ultrasound device. The Vscan looks like a cross between an iPod and a cell phone, making it possibly the world's smallest ultrasound. Later today we'll be attending GE's healthymagination technology showcase in New York where further details and specs will hopefully become available.

For critical care clinicians, Vscan can offer an immediate look beyond patient vital signs with the potential to identify critical issues, like fluid around the heart, which could be a sign of congestive heart failure. And for cardiologists, Vscan provides a dependable visual evaluation of how well the heart is pumping at a glance, so they can treat patients more efficiently.

Tiny Portable Ultrasound from SonoSite Gets US OK

Mon, 05 Oct 2009 11:56:09 -0800

SonoSite (Bothell, Washington) just announced that the company received FDA approval to market the firm's tiny NanoMaxx ultrasound system throughout the United States. Weighing in at only 6 pounds (2.7 kilo) and with a battery life of 2 operational hours, the system is truly portable for busy clinics, ambulances, emergency rooms, and elsewhere that ultrasound is needed.

The new ultra portable and one button design of the NanoMaxx system makes high quality ultrasound available to a much broader range of clinicians. The system incorporates SonoSite’s advanced proprietary imaging algorithms, including SonoMB™ and SonoAdapt™ to deliver superior image quality in a lightweight, rugged form factor.

With a touch screen that responds easily to the tap of a finger, and one button optimization, clinicians can readily acquire high resolution images to increase clinical productivity at the point-of-care. A system boot-up time of less than 20 seconds and long battery life further enhance workflow when using the NanoMaxx system.

At introduction, the NanoMaxx tool is available with a complement of five transducers to support a wide range of examinations and procedures including thoracic assessment for pathology, vascular access, needle aspirations and injections, as well as abdominal, cardiac, nerve, OB/Gyn, musculoskeletal, small parts and vascular scanning.

For convenience and flexibility, the system can be wall mounted, placed on an exam table with kickstand attached, or used from a highly maneuverable stand. Physicians can easily carry the NanoMaxx tool from room-to-room, to a satellite office, to the operating room or to a field site for immediate use.

The NanoMaxx system’s highly integrated architecture and ruggedized design, including the industry’s first elastomeric bumper for extra durability, plus magnesium outer shell, allows it to be used in the most demanding and austere environments. Proving its reliability, the NanoMaxx system and its transducers successfully passed SonoSite’s standard three foot durability drop test.

In addition, to further reduce the risk of infection, the NanoMaxx system’s fluid-resistant user interface makes the system easy to clean and disinfect, helping to address the growing concern over infection control in the medical community.

Press release: SonoSite Announces FDA Clearance for Its New Nanomaxx Ultrasound Tool

Product page: NanoMaxx

Flashback: NanoMaxx Tiny 6 Lb. Ultrasound System Unveiled

NUVADERM Liquid Bandage For Scratches, Burns, Bruises Gets 510(k)

Thu, 06 Aug 2009 00:00:03 -0800

Watch out Dermabond! The FDA has given approval to Chesson Labs out of Durham, NC for company's NUVADERM™ liquid bandage. The product, approved for marketing to healthcare professionals and directly to consumers, is either sprayed or brushed on to "to cover intact skin and minor cuts, scrapes, burns or irritations of the skin, to help keep them clean and dry and help protect them from infection." The non-toxic material keeps moisture and dirt from penetrating the applied film layer while allowing oxygen to reach the wound site.

Some technical details of the NUVADERM:

NUVADERM is a single component, poly(urea-urethane) liquid emulsion polymer that is composed of large, highly complex molecules that incorporate a broad range and distribution of hard and soft segments. The different segments are tied together with urea and urethane linkages that are formed during synthesis. NUVADERM is applied topically to form a non-toxic, hydrophobic, elastomeric coating that provides a barrier against moisture but that is permeable to oxygen. NUVADERM requires no initiator or catalyst and therefore no mixing steps. It remains liquid until released into the air and therefore is applied by spraying or with an applicator brush.

Press release: Chesson Labs Liquid Bandage Product NUVADERM® Receives FDA510(k) Market Clearance (.pdf)...

Product page: NUVADERM...

Technical Data Sheet (.pdf)...; Anti-Microbial Data (.PDF)...

MicroEye Real Time Blood Monitoring System

Tue, 21 Jul 2009 00:37:28 -0800

The Engineer Online reports on Probe Scientific, a firm out of Bedford, UK, that has developed a continuous blood composition monitoring device that doesn't draw blood from the patient. The MicroEye system connects via most venous catheters and is already approved in Europe.

From the product page:

The MicroEye is intended for intravenous use for periods of up to 48 hours and is inserted via an 18G blood catheter. The range of substances that can be monitored using the MicroEye is vast including:
Electrolytes (such as potassium, magnesium etc.)

Energy metabolites (e.g. glucose, lactate, pyruvate, etc.)

Amino acids (glutamate, GABA, etc.)

Hormones and neurotransmitters (such as dopamine, serotonin (5-HT) etc.)

Inflammatory mediators and growth factors (e.g. cytokines, etc.)

Drugs and their metabolites (unbound 'free' fraction and / or total)

Product page: MicroEye...

(hat tip: The Engineer Online)

VasoNova Gets to The Heart of The Matter

Fri, 17 Jul 2009 00:00:03 -0800

Placement of a peripherally inserted central line so its tip is located at the lower third of the superior vena cava, just prior to the right atrium, is always a guessing game. Nowadays, the only way to confirm position of the line is to do an X-ray of the chest. VasoNova out of Sunnyvale, California wants to change the rules of the game. The company is introducing a device that uses Doppler ultrasound to monitor direction of blood flow and ECG to help position the catheter at the optimal location.

The VasoNova VPS consists of several components: the VPS Stylet, the VPS Power Injectable PICC catheter and the VPS Console.

The VPS Stylet contains two sensors at its tip: a Doppler Ultrasound sensor and an intravascular ECG lead. Due to the ingenuity of our R&D group, VasoNova was able to miniaturize the two sensors and construct a highly technical and flexible stylet that can fit into the lumen of the VPS Power Injectable PICC line with comparable dimensions to other market available PICC lines12. Once the VPS stylet is loaded into the VPS catheter and connected to the VPS console per the Instruction for Use, the VPS Stylet is able to detect the patient's physiological data, such as blood flow characteristics and ECG waveform. From the point of insertion, patient data are sent to the VPS console for analysis. Using the highly advanced hardware and complex algorithm, the VPS console analyzes multiple vectors derived from these data and determines the location of the catheter tip while it is advanced through the patient's vasculature. Using the data gathered by the sensors and analysis done by the console, the VasoNova VPS console displays visual indicators. These indicators guide the clinician in real-time as the catheter is advanced through the vasculature:

The green arrow indicates the catheter tip is moving with the blood flow towards the heart, as appropriate.

The orange "do-not-enter" sign indicates the catheter is moving against blood flow, such as into the internal jugular vein and away from the heart, or has passed the lower third of the SVC and going into the right atrium.

The yellow triangle indicates there is not enough information available, which may occur if the catheter tip is against the vessel wall.

The blue bull's eye indicates the tip has arrived in the lower 1/3 of the SVC or at the caval-atrial junction.

Product page: VasoNova VPS...

Pressure Alert for ETTubes

Thu, 16 Jul 2009 00:03:45 -0800

Another medically related entry to the James Dyson Award contest is the Pressure Alert for endotracheal tubes, a device intended to prevent the overinflation of the cuff balloon. Currently anesthesiologists and others have to use either their fingers to feel for pressure in an external balloon, or to use a specialized manometer that measures an internal pressure. The proposed system aims to take any guessing out of the process. If proven feasible, the same device, of course, can be used for trachs, double lumen endotracheal tubes, or even for endobronchial blockers.

The “Pressure Alert” is a unique adaptation for a medical device called an Endotracheal Tube, which is inserted into the patient’s airway allowing them to breathe during anaesthesia. The airway is sealed to prevent leaks by inflating a balloon called a “Cuff”. If the “Cuff” pressure is too high, it could bruise/split the trachea. Currently, a safe pressure is judged by feeling a “Pilot” balloon, but even seasoned anesthetists can misjudge this delicate procedure. “Pressure Alert” is the first device that gives a “pop-up” warning (patent pending), integrated into the pilot balloon to alert the user that pressure is too high, both at the start and during the operation. Additional USPs 1. The familiar mechanism helps user improve existing technique 2. The device offers instant recognition of potential danger 3. Requires no retro-fitting 4. Cost-effective production and lower environmental impact 5. Reduces patient recovery-times & risk of injury

Video showing off the prototype device:

Link: Pressure Alert for an Endotracheal Tube ...

NanoMaxx Tiny 6 Lb. Ultrasound System Unveiled

Tue, 07 Jul 2009 10:37:30 -0800

SonoSite announced this morning the release of a new portable ultrasound NanoMaxx system that weighs only 6 pounds. The company claims that this point-of-care ultrasound produces imagery similar in quality to the firm's flagship M-Turbo model. Designed for mobile applications (such as private offices, emergency rooms or EMRs, central line accesses on the floor, etc.), the system sports battery with two hour life. For this model the company offers a comprehensive line of transducers that deliver "high resolution diagnostic imaging across a range of clinical applications to support clinical diagnosis and to guide interventional procedures." Ready to be distributed internationally, the device still needs final approval from the FDA to be marketed in the US.

Features from the announcement:

One Button Technology Optimizes Workflow
Based on SonoSite’s 4th generation Turbo technology platform, the NanoMaxx system incorporates proprietary, advanced imaging algorithm technologies, including ColorHD™ to deliver exceptional image quality in a lightweight, rugged form factor.

With a touch screen that responds easily to the tap of a finger, and one button optimization, clinicians can readily acquire high resolution images to increase clinical productivity at the point-of-care. A system boot-up time of less than 20 seconds and long battery life further enhance workflow when using the NanoMaxx system.

Designed to Help Hospitals Meet New Standards of Care
Clinical studies have proven that bedside ultrasound increases the accuracy of interventional procedures and it is now recommended by two government-based agencies1 and three US medical societies.2 At introduction, the NanoMaxx tool is available with a complement of five transducers to support a wide range of examinations and procedures including thoracic assessment for hemothorax, hydrothorax and pneumothorax, vascular access, needle aspirations and injections, as well as abdominal, cardiac, nerve, OB/Gyn, musculoskeletal, small parts and vascular scanning.

The clinical capabilities of the NanoMaxx will help eliminate the risk and cost of transporting patients to the imaging lab for many examinations and procedures.

Mount it. Carry it. Or Use it on a Stand
The small footprint of the NanoMaxx system, along with its space-saving solutions, enables seamless integration with a variety of exam-room configurations. It can be wall mounted, placed on an exam table, or used from a highly maneuverable stand. Physicians can easily carry the NanoMaxx tool from room-to-room, to a satellite office, the operating room or to a field site for immediate use.

Built to Last
The NanoMaxx system’s highly integrated architecture and ruggedized design, including the industry’s first elastomeric bumper for extra durability, allows it to be used in the most austere and demanding environments. A magnesium shell that is significantly stronger and lighter than plastic helps to protect the system against accidental droppage. As with all SonoSite systems, the NanoMaxx ultrasound tool and its transducers are built to withstand a one meter drop test.

Product page: SonoSite NanoMaxx...

Press release: SonoSite Introduces The 6 Lb. NanoMaxx - A Breakthrough Ultrasound Tool Aimed At Reducing Patient Safety Risks And Healthcare Delivery Costs...

LUCAS 2 Automatic Chest Compressor Gets US Green Light

Mon, 29 Jun 2009 11:10:32 -0800

The LUCAS™ 2 chest compression system from Jolife AB, out of Lund, Sweden, has just been approved by the FDA. The battery powered unit can be taken directly to the patient without the need for a compressed air supply, unlike the last model. The system can then pump the chest for up to 45 minutes, saving paramedics' time and much needed energy once the patient is revived and rushed to the hospital.

From the announcement by Medtronic:

LUCAS 2 builds upon the well-proven LUCAS™ 1 technology, but differs from its predecessor in that it is an electric rather than a pneumatic device. LUCAS 2 can be powered either by battery alone or using a wall or car electricity outlet. The battery is the latest in rechargeable, Lithium Ion Polymer technology and operates for up to 45 minutes (typical) on a single battery. LUCAS 2 is equipped with Smart Restart functionality. When a battery needs to be replaced, LUCAS 2 does not have to be powered down, only put into the pause mode, and when the new battery is inserted, the start position will stay the same within 60 seconds from the pause. Operation can be quickly resumed, saving time for medical personnel. LUCAS 2 offers other new features such as alerts and pauses to aid ventilation during compressions with an unsecured airway (e.g. bag-valve-mask) and quieter operation.

LUCAS 2 weighs only 17.2 lbs (7.8kg) and fits into a compact backpack measuring just 25.6h x 13w x 19.8d inches (65h x 33w x 25d centimeters).
Within the past month, LUCAS 2 has also received a CE (Conformité Européenne) Mark in Europe and marketing approval from Health Canada. Physio-Control plans to begin shipping to the U.S. markets in the fall.

Here's a video loop demonstrating the operation of LUCAS 2:

Product page: LUCAS™2 Chest Compression System...

Press release: FDA Grants LUCAS™ 2 Chest Compression System 510(k) Clearance in the United States...