Medgadget

Medtronic's MiniMed Paradigm REAL-Time Revel System Receives FDA Approval

Fri, 19 Mar 2010 00:00:01 -0800

Medtronic has received FDA approval for its integrated diabetes management system called MiniMed Paradigm REAL-Time Revel System. The system combines insulin pump therapy, continuous glucose monitoring and diabetes therapy management software. It features predictive alerts which signal trends in blood glucose levels notifying patients to take preventive measures. For maximal comfort it can be combined with the Medtronic wireless continuous glucose monitoring system and measurements can be uploaded to the online Carelink personal management software. The system is made available immediately in five different colors.

Press release: Medtronic Receives FDA Approval for Industry's Most Advanced Integrated System for Diabetes Management ...

Product page: MiniMed Paradigm® Revel™ Insulin Pump ...

NOTE: We would like to welcome Dr. Wouter Stomp to Medgadget editorial board. He is an MD from the Netherlands, currently working on PhD in radiology. This is his first post.

Mendor Portable Blood Glucose Meter Announced

Mon, 15 Mar 2010 10:41:33 -0800

Mendor, a new company out of Helsinki, Finland, is preparing to launch a new blood glucose meter that is promised to be easier and more discreet to use than currently available models. The device, soon to be available in Europe, has a built in mechanical lancer and test strips. This makes it a convenient, self contained package, about the size of a cell phone, that doesn't require additional components to be brought along. Details about the device are still slim, but we'll be providing those once they become available.

More from Amy Tenderich at DiabetesMine: New Cellphone-Like All-in-One Glucose Meter from Finland...

Link: Mendor Blog...

Environmentally Friendly Syringe Minimizes Packaging to Save Resources

Thu, 11 Mar 2010 09:07:15 -0800

Cambridge Consultants, a product design and development firm, has created a new prefilled syringe that uses fewer resources to manufacture than many current models. Unsurprisingly, the green syringe was named Syreen, but its environmental credentials are only part of the features of the new device.

Instead of glass, Syreen syringes are made with COP (cyclic olefin polymer) plastic, which has enabled Cambridge Consultants to shed the need for secondary packaging altogether, a first in this medical device arena. The makeup of the Syreen allows syringes to clip together, nesting in a pack while the COP design doubles as the outer shell of the packaging itself. The Syreen therefore eliminates the need for wasteful fillers such as cardboard and styrofoam, reducing the packaging weight by 30 percent and volume by 50 percent from today's standard packaging.

To use Syreen, simply unclip the prefilled syringe and put it against the desired area on the skin. After delivery, with a simple snap, the user ejects the needle into the sharps bin and allowing the user to potentially recycle the plastic capsule. Patient and healthcare provider safety is also increased due to two further features of the design. Firstly, the COP plastic syringe features a curved surface over the needle that, while keeping the syringe from rolling and reducing needle-stick accidents, also ensures overall stability and depth control during injection. Secondly, the design insures that, with separated plunger and stopper, it is impossible to take in blood or other contaminants, reducing the risk of cross infection.

Press release: Novel syringe demonstrates cost benefits of sustainable product design...

Panasonic Unveils New Rugged Mobile Computer

Tue, 02 Mar 2010 09:43:30 -0800

Today Panasonic is unveiling its new business tablet meant for clinicians and medical personnel to use in office and around the hospital. Last week in San Francisco we got a chance to check out the C1 Business Rugged Toughbook. The 12.1" computer can be used as a standard laptop or converted into a touch tablet for use with a pen or directly with your fingers. The 1280x800 WXGA screen is multi-touch sensitive, so you can use finger gestures to intuitively manipulate images and other documents. Some of the interesting features of the C1 Toughbook include a handstrap on the back of the unit which makes holding it easy in tablet mode, a round touchpad which can be used like an iPod scroll wheel, and space for two hot swappable batteries. The hard drive is easy to pop out as well, so you can take all the sensitive data with you while grabbing a sandwich at the cafeteria without bringing the whole machine.

The strangest thing about the laptop is its unusual proportion between size and weight. Basically, it looks larger than it weighs. Because it is a rugged laptop, which means it can be dropped on concrete and have water splashed at it, it has some empty space within to cushion any blows and channels to direct liquids into a port hole on the bottom. And so it's considerably fatter in depth than other machines in this range. But when you hold it, it's impressively light and comfortable. That's because at 3.2 lbs (3.7 lbs with two batteries), it's the lightest 12.1" convertible laptop on the market.

We asked Kyp Walls of Panasonic to give a quick tour of the device to our readers:

Full feature list of the Panasonic C1 Toughbook, under the fold:

Pantec's P.L.E.A.S.E.Transdermal Therapeutic System Shows Early Clinical Success

Fri, 26 Feb 2010 00:46:26 -0800

Pantec Biosolutions of Liechtenstein just announced positive results from a Phase I clinical trial of the FSH (follicle stimulating hormone) patch when used in conjunction with the firm's proprietary P.L.E.A.S.E. microporation drug delivery device. The system, profiled by us before, uses painless lasers to create cutaneous micropores prior to transdermal injection of large molecular weight drugs. The P.L.E.A.S.E. system is designed to be flexible in the number of the micropores and the depth of delivery, allowing to fine-tune the amount of a therapeutic injectate.

From the latest announcement:

Although smaller peptides and some proteins have previously been delivered transdermally, this is the first time a molecule as large as this protein (32 KDa) has been successfully delivered in this way.

The purpose of the study was to investigate the primary pharmacokinetic characteristics as well as the safety and tolerability of the newly developed FSH protein patch in healthy male volunteers. Due to its size and physicochemical properties FSH, a 32 KDa protein hormone, cannot permeate passively across intact skin. Therefore, prior to patch application, the skin was microporated using Pantec Biosolutions’ P.L.E.A.S.E.® laser device. This pre-treatment creates microchannels in the skin’s outermost layer, the stratum corneum, that facilitate FSH transport through the skin and accelerate its entry into the systemic circulation.

The serum profiles further demonstrated that the P.L.E.A.S.E.® – FSH patch combination was able to achieve reproducible pharmacokinetics with negligible inter-individual variability. All of the volunteers considered the method to be convenient and easy to use, and there were no reports of any adverse events.

Product page: The P.L.E.A.S.E. - platform ...

Animation showing the functionality of the P.L.E.A.S.E. system...

Press release: Pantec Biosolutions reports successful Phase I for delivery of FSH using P.L.E.A.S.E. ...

Flashbacks: P.L.E.A.S.E. = Painless Laser Epidermal System ; P.L.E.A.S.E. To Improve Effectiveness of Drug Patches

Thinklabs iPhone App Pairs Up With Electronic Stethoscope

Mon, 22 Feb 2010 12:03:53 -0800

Thinklabs Medical, maker of the electrostatic ds32a stethoscope, has released an iPhone app that can record, playback, and visually display auscultation sounds. Basic editing and visualization options are built into the app, along with ability to save and email recordings.
There's also a prerecorded library of sounds that can be used as a teaching aid or for general reference when listening to a patient.

Features of the app:

Record and Display waveforms and spectrogram in real time.

Scroll and Zoom In/Out using multi-Touch user interface.

Edit Sounds on-screen.

Save Recorded sounds.

Email Sounds and Images, along with notes.

To listen to heart sounds, an electronic stethoscope is required. The Thinklabs Digital Stethoscope ds32a has been tested with the iPhone and iPod Touch. An external Made for iPod / Works with iPhone audio input device with audio input jack is required in order to connect the stethoscope to the iPod. We recommend the Belkin TuneTalk.

Product page: Thinklabs Stethoscope App ...

Flashback: Thinklabs ds32a Stethoscope with Electromagnetic Diaphragm

(hat tip: TMCnet)

GE's Vscan, World's Smallest Portable Ultrasound, Now Available Worldwide

Tue, 16 Feb 2010 00:56:00 -0800

GE Healthcare is finally releasing the much awaited Vscan pocket sized ultrasound. Many in the industry hope that this device offers a chance for physicians to make a move from stethoscopes to portable imaging devices, bringing advanced visualization to any examination room. The unit weighs one pound and is only 3 inches (7.6 cm) wide and 5.3 inches (13.5 cm) long, offering both standard black and white imaging, as well as colored blood flow doppler. GE is touting Vscan's size and capabilities for cardiologists to transthoracically view myocardium, pericardium, and heart valves, and for primary care physicians, as well as OB, ER, and others, to scan the liver, kidney, aorta and peripheral vessels, babies in the womb, and anything else the transducer can penetrate.

Features from the product FAQ:

An online portal provides Vscan users with training tools for the product and basic clinical
applications with sections about imaging technique, anatomy and trouble shooting

Intuitive user interface that can be controlled using the thumb

Intelligent workflow enhancements

Battery charger station and battery life of one hour scanning - good for up to 30 patients based on
average of 2 minutes per scan

Voice annotation

USB docking station

Link to a PC for organization and export of data

Gateway software with services tools and remote diagnostics

Here's our video from a GE event introducing the Vscan:

Press release: GE Healthcare Introduces Vscan™ Pocket-sized Visualization Tool for Point-of-care Imaging

Product page: Vscan ...

Flashbacks: A Closer Look at GE's Vscan Pocket Ultrasound ; More Details About The New GE Vscan Ultrasound System; GE's New Ultra Small Ultrasound May Become as Ubiquitous as Stethoscope

We See the Future: A World Without Quotient ADHD System

Thu, 11 Feb 2010 07:44:25 -0800

Here's an idea for a startup. Someone has to write an application for computers and game consoles that can ask kids to perform various tasks, watch them via a webcam, and help clinicians diagnose ADHD. Sure, product development and trials will cost millions, but the end result, say in the form of a friendly Wii game, should be more palatable than the monster on the right. Would you be able to sit still in front of the Quotient ADHD System from BioBehavioral Diagnostics Co., a Westford, Mass firm? We doubt it. Perhaps sticking a few strategically placed Dilbert cartoons on the walls of this system would help take the drab out of it. Regardless, this is the option currently available and if your office needs one then the fantasy Wii version is no competition for an existing system.

Here's more about the Quotient ADHD technology:

The Quotient™ ADHD System collects and reports objective, accurate data on hyperactivity, impulsivity and inattention. The clinician integrates the Quotient™ ADHD Test report with information from other assessment tools and the clinical evaluation to guide treatment decisions.

ADHD historically has been challenging to diagnose because many of the assessment tools rely largely on subjective information from parents and teachers, in addition to clinical evaluation.

The Quotient™ ADHD System accurately measures motion and analyzes shifts in attention state to give a clear picture of ADHD symptoms. The Quotient™ ADHD Test gives objective and accurate data on the core symptom areas of ADHD:

Hyperactivity (the inability to control movement and sit still while working)

Impulsivity (the inability to inhibit inappropriate responses)

Inattention (the difficulty in staying focused and on task)

1. Motion Tracking System
The Motion Tracking System captures each movement 50 times per second and plots the pattern of movement of the reflector(s).

2. Reflectors
A small reflector is placed on the forehead. If the patient is 13 years old or older, additional reflectors are placed on the shins to capture leg motion.

3. LCD Screen
The patient responds to different geometric shapes that flash randomly on the LCD screen

4. Keyboard
Patient responds to visual stimuli by pressing the space bar.

Product page: Quotient™ ADHD System...

MassDevice: BioBehavioral Diagnostics closes $7 million tranche in Series B round...

Riester Unveils New ENT Scopes

Thu, 11 Feb 2010 07:43:04 -0800

Riester out of Jungingen, Germany has released a new line of ophthalmoscopes and otoscopes that feature efficient cool white LED lighting, easy battery management, quick swapping of instrument heads, and a choice of using handles built for C or AA batteries.

All the ri-scope® L- series’ E.N.T. (ear, nose and throat) diagnostic instruments feature Riester’s new LED lighting technology that provides a whiter light, improving examinations because of its enhanced image clarity and colour contrast. The area under examination is shown in true-colour – the improved red-colour contrast aiding a reliable and exact diagnosis. Lamps with LED technology have a lifetime of at least 10,000 hours, compared to just 20-30 hours for halogen and xenon lamps.

The ri-scope® L range combines energy efficient LED technology with a long lasting, light-weight lithium-ion (Li-Ion) battery to ensure sustained, high-power performance and significant cost savings. Li-Ion batteries have the benefit of achieving a considerably higher charging capacity and longer lifetime than regular batteries and provide sustained high performance for up to 1200 charging cycles.

Riester also recently launched its heotronic® technology for instrument handles. This new patent pending technology makes it possible to power both LEDs and conventional bulbs electronically. This means that all ri-scope® L instrument heads only need one handle, no matter which kind of illumination is selected. 100% light output is guaranteed immediately after a slight turn of the electronic switch and it is possible to regulate light intensity very smoothly in both directions. An automatic turn-off function after 120 seconds guarantees that LEDs, bulbs and the Li-Ion rechargeable batteries are conserved and can be used as long as possible.

All ri-scope® L instrument heads can be used with C- or AA-handles, making them portable, or with the Riester diagnostic wall mounted station, the ri-former®.

Press release: New High Performance ri-scope L Ophthalmoscopes and Otoscopes from Riester ...

Product page: ri-scope® L ...

ri-scope® L brochure... (.pdf)

Toshiba's Viamo Ultrasound Now Available in US

Thu, 04 Feb 2010 09:57:45 -0800

Toshiba won FDA approval to market the Viamo portable ultrasound, a convertible touchscreen device that the company promises provides the same image quality as premium cart systems. The package comes with a wheeled pole that can carry the Viamo and additional transducers for easy exchange.

From the product page:

Sharing its core imaging engine and transducer technology with Aplio XG, Viamo offers high-end image quality also in situations where unlimited portability is required.

Its full range of high-performance imaging functions lets you visualize minute tissue details and vascular structures with precision for a faster, more accurate diagnosis. Advanced imaging functions such as Pulse Subtraction THI come standard with Viamo.

Viamo’s built-in touch screen allows for seamless workflow and an outstandingly comfortable and intuitive operation of the system. Viamo’s monitor can be rotated to enable free positioning of the screen. When fully turned and folded flat, Viamo can be operated in tablet mode solely via its touch screen. Individual key functions on Viamo’s console and touch screen are user programmable to suit your specific diagnostic requirements or personal preferences.

A whole range of workflow automation functions is available on Viamo. One-touch QuickScan for instance helps you achieve better imaging results in less time by automatically optimizing your imaging parameters. And Viamo’s innovative SonoSet™ function alows you to carry out examinations conveniently by simply executing freely programmable protocols step by step.

The battery-powered system is operational within just a few seconds when opened, making it instantaneously available also in critical situations.

Press release: TOSHIBA RECEIVES FDA CLEARANCE FOR VIAMO ULTRASOUND SYSTEM...

Product page: Viamo...

Product brochure...