Medicine Archive

Wednesday, March 17, 2010

Dyna-Vision Real-Time Remote Patient Monitoring System Gets US Green Light

RS TechMedic BV out of Broek op Langedijk, The Netherlands has received FDA 510(k) clearance for its Dyna-Vision line of portable cardiac monitors. The devices, already approved in Europe, transmit ECG data wirelessly to a clinician via Bluetooth or through a mobile phone network.

Features of the top end Dyna-Vision device from the product page:

Remote Monitoring of Vital Signs: > 3, 5 and 12 lead ECG > Heart Rate > Plethysmogram & SpO2 > Respiration & Respiratory Rate

Benefits:
> Real-Time Remote Monitoring without limitations
> Internal GSM, Bluetooth Class I and USB connection
> No peripherals required for transmission
> Dyna-Vision© supports all mobile networks

Turn-key Telemedicine Solutions and Interfacing:
> Integration of Dyna-Vision© in existing platforms
> Server Solution, PC software and monitoring devices
> Remote Cardiac Diagnostic Services

Here's a demo video about Dyna-Vision:

Product page: Dyna-Vision...

Here's an interview Ivor Kovic, our former editor, took with the CEO of RS TechMedic in October 2008: Dyna-Vision Monitoring from RS TechMedic...

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Monday, March 15, 2010

Mendor Portable Blood Glucose Meter Announced

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...

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Friday, March 12, 2010

Duraspan Biomimetic Coated Hemodialysis Catheter

r⁴ Vascular out of Maple Grove, Minnesota has released a new catheter for patients on long-term hemodialysis. The Duraspan catheter aims to prevent thrombus accumulation thanks to its biomimetic coating that discourages clot formation.

A novel coating on the catheter surface mimics the glycocalyx layer found on natural endothelial tissue surfaces in vessel walls. Laboratory tests of the Duraspan™ catheter have demonstrated an 87% reduction in platelet adhesion and thrombus accumulation compared to uncoated catheters.
R4 is committed to improving dialysis patient catheter outcomes according to r⁴ Vascular's President, Don Geer, "physicians have long thought that if one was able to make the catheter less recognizable as a foreign object in the body it could revolutionize catheter-based hemodialysis. Developing the catheter, r⁴ Vascular engineers utilized stealth coating technologies, approaching the thrombus problem by camouflaging the catheter in a biomimetic coating." The catheter is available in either a 3.5cm tip stagger or a 7cm tip stagger version, providing reduced recirculation.

Press release: New Dialysis Catheter Reduces Thrombus Accumulation... (.pdf)

Product page: Duraspan™ Coated Dialysis Catheter ...

Duraspan Coated Dialysis Catheter product brochure...

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Thursday, March 11, 2010

Environmentally Friendly Syringe Minimizes Packaging to Save Resources

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...

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Wednesday, March 10, 2010

ICON CPAP Machines from Fisher & Paykel

Fisher & Paykel out of Auckland, New Zealand has released a new line of CPAP machines that smudge the line between medical devices and consumer products. The ICON line features a built-in alarm clock and an mp3 player, along with all the company's latest CPAP technology.

From the announcement:

The product range spans three models; Auto, Premo and Novo. The Auto detects interruptions to normal breathing and provides the appropriate positive airway pressure to meet the breath-by-breath needs of the patient with full efficacy and compliance reporting. The Premo model provides fixed pressure therapy with efficacy and compliance reporting, while the Novo provides basic compliance reporting.

The ICON range also includes Fisher & Paykel’s InfoSmart technologies, which will provide a full range of communication and compliance reporting options.

Features of the device:

Auto-adjusting pressure for personalised treatment during sleep.

Fisher and Paykel's unique SensAwake breathing algorithm - Described by users as one of the best advances in CPAP technology ever, it detects a user waking up and drops pressure accordingly to aid the transition back to sleep.

ThermoSmart and heated tube - Get more humidity to you and less condensation to your tube.

Built-in alarm clock-mp3 player - Wake up to your music in the morning!

One of the quietest CPAP machines presently on sale.

Travel bag, tube, manuals, power cord, international plugs, compliance memory-stick and extra filters.

Press release: FISHER & PAYKEL HEALTHCARE INTRODUCES NEW CPAP RANGE...

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Monday, March 8, 2010

sterEOS 2D|3D Workstation Images Spines With Significant Radiation Reduction

Biospace Med, maker of X-ray imaging systems out of Paris, France, just received FDA approval to use the firm's sterEOS 2D|3D workstation on pediatric patients to image the spine. The company claims that the system provides imagery competitive to that of CT scanners, but with only .1% of the radiation dose. Patients remain standing while the system simultaneously takes an X-ray from the front and laterally, after which a computer reconstructs the two frames into a three dimensional representation of the spine. This allows for quick imaging of patients in a weight bearing position while significantly reducing their radiation exposure compared with CT.

From the press announcement:

“FDA clearance for sterEOS pediatric use in spine will have a significant impact on demand for EOS as it will allow for the first time to visualize in 3D the spine deformations in the standing, weigh bearing position and retrieve fundamental clinical parameters for surgical planning. This is all done at a drastically reduced radiation exposure, and enables to repeat exams for a better follow up from childhood to adulthood,” said Peter Newton, M.D., Rady Children’s Hospital, San Diego, Ca. “Reduction of radiation exposure is especially important for children and adolescents who have scoliosis or other types of musculoskeletal disorders that are being followed on a frequent basis and therefore need to have regular x-rays over a long period of time to watch the progression of their condition and treatment. A technology that can reduce radiation exposure up to 10 times compared to a conventional x-ray and up to 100 or more times compared to a CT scan is a major breakthrough for orthopedic imaging, especially for the pediatric population.”

Press release: FDA clears Biospace med's sterEOS 2D|3D workstation for pediatric use in spine...

Biospace Med homepage...

(hat tip: MassDevice)

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SofPulse Electromagnetic Field Pulsating System Helps Moderate Osteoarthritis Symptoms in Diseased Knees

At the Henry Ford Hospital in Detroit, Michigan researchers have been testing the effectiveness of a pulsed electromagnetic field device to help with pain and inflammation management in patients with osteoarthritis of the knee. According to Ivivi Health Sciences of San Francisco, California, the maker of SofPulse System, its device produces pulsed electromagnetic fields (PEMF) to induce micro-currents in injured tissues, which in turn are thought to act on the binding kinetics of calcium and calmodulin to increase production of nitric oxide which then reduces inflammation. Paint us skeptical, but hopefully the company is right on the physiology of its device. The findings of the latest study will be presented at this week's Orthopaedic Research Society's annual meeting in New Orleans.

From a statement by the Henry Ford Health System:

In the double-blind, randomized placebo-controlled study, 34 patients used a portable battery-operated device that emits a low-intensity pulsating electromagnetic frequency and experienced more than 40 percent pain relief on their first day.

Patients strapped the small, ring-shaped plastic device around their knees for 15 minutes, twice daily for six weeks. The device was lightweight and patients could position the device directly over clothing. All participants were given a device with a coil that appeared to work but some were assigned active coils and others were given non-active coils.

Press release: Electromagnetic Pulses Provide Pain Relief ...

Product page: Ivivi's SofPulse ...

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Friday, March 5, 2010

Breath Test Proving Effective for Detection of Pulmonary Tuberculosis

Menssana Research, Inc is touting results from a trial testing its Breathscanner for diagnosing patients with active pulmonary tuberculosis. Menssana has developed technology that may bring breath testing for a variety of conditions, including the already FDA approved breath test for heart transplant rejection.

Some details about the technology from Menssana:

The Mycobacteria that cause pulmonary TB generate a very distinctive pattern of volatile organic compounds (VOCs) when grown in the laboratory. If these VOCs could also be detected in the breath of infected patients, it might provide a new method for detecting active infection with pulmonary TB. The National Institutes of Health (NIAID) awarded Menssana Research a Phase I SBIR grant to test the feasibility of this idea. We analyzed breath VOCs in hospitalized patients who were being screened for pulmonary TB at New York University Medical Center, New York. We also analyzed the VOCs manufactured by Mycobacteria grown in the laboratory at Saint Vincents Medical Center, New York.
We found that breath biomarkers of oxidative stress clearly distinguished between the "sick" hospitalized patients and normal controls. Also, breath VOCs accurately identified the patients whose sputum samples grew Mycobacteria - the VOC biomarkers in breath and in sputum cultures were very similar (see pdf).

Based on these encouraging findings, NIH/NIAID awarded Menssana Research a Phase II SBIR grant to validate the breath test for pulmonary TB in a larger multicenter international study performed in San Diego, London, and two sites in the Philippines and Mexico. The results, soon to be published in the journal Tuberculosis showed that the breath test identified active pulmonary TB with 85% accuracy.

The US Air Force is currently funding a new study of a point-of-care breath test for active pulmonary TB that delivers results in minutes.

Abstract in journal Tuberculosis: Breath biomarkers of active pulmonary tuberculosis

Link: Menssaba breath test for pulmonary tuberculosis...

Press release: Breath Test for Pulmonary Tuberculosis ...

Flashback: The Breathscanner 1.0...

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Thursday, March 4, 2010

Vidacare's OnControl Marrow Aspiration and Biopsy System

Bone marrow aspiration is just about the most unpleasant clinical procedure for both the patient and doctor. Drilling into an awake and conscious person's ischial tuberosity has a similar flavor to performing surgery 200 years ago with the patient screaming in pain and chewing on a whiskey cloth. The trick is to do it quick while getting a usable sample to send to the lab. To that end, Vidacare out of Shavano Park, Texas has released the new lithium batter powered OnControl Aspiration System that the company believes will bring a much needed new level of efficiency to this procedure.

From the press release:

Prior to its full launch, Vidacare implemented a validation study to measure successful sample acquisition rates, quality of sample, ease of use, and overall user satisfaction. Thirty-one clinicians from thirteen sites in the U.S. participated in this evaluation, and all were first-time users. Testing sites included the Cancer Research and Technology Center of the University of Texas/San Antonio (San Antonio, Texas), M.D. Anderson Cancer Center (Houston, Texas), Wilshire Oncology (Glendora, CA) and Kaiser Permanente Riverside (Riverside, CA) among others. Of the 84 patient procedures completed during the validation testing, results show:
Mean user satisfaction score of 4.4 (on a scale of 0-5, with 5 indicating high satisfaction)

Needle insertion success rate of 94%

Biopsy core acquisition success rate of 90%

Mean length of core sample of 1.32 cm

Median time to core extraction of 81 seconds

Product page: OnControl ...

Press release: Vidacare's OnControl Bone Marrow System Is Quantum Leap Forward for Bone Marrow Procedures...

Demo video below the fold:

Tuesday, March 2, 2010

Panasonic Unveils New Rugged Mobile Computer

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:

Friday, February 26, 2010

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

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

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Monday, February 22, 2010

Thinklabs iPhone App Pairs Up With Electronic Stethoscope

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)

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Tuesday, February 16, 2010

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

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

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Thursday, February 11, 2010

Riester Unveils New ENT Scopes

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)

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Thursday, February 4, 2010

Toshiba's Viamo Ultrasound Now Available in US

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...

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Thursday, January 28, 2010

InJentle Staked Glass Syringe from SCHOTT

Cambridge Consultants, based in both Cambridges across the Atlantic, is profiling the InJentle syringe it designed along with SCHOTT of Mainz, Germany. The glass syringe has some interesting safety and storage features that may be quite useful for dealing with certain drugs.

InJentle's unique design, employing a ‘pinch seal’ closure, ensures that the drug is not in contact with the metal needle or the adhesive of the syringe during storage, preventing sensitive drugs from interacting with these potential contaminants. This also has the advantage of creating similar stability test requirements as vials. The needle shield has also been designed with robust tamper-evident closure. This enables physicians or patients to determine easily if the syringe is still unused. InJentle™ also includes the flexibility to include further anti-counterfeiting features in the future, such as RFID tags.
SCHOTT InJentle™ incorporates a needle shield that protects the needle and minimizes the risk from the occurrence of ‘hooks’. Sharper ‘virgin’ needles make the injection less painful for patients. In addition, InJentle™ can be combined with particularly thin needles - potentially up to 32 gauge - which are also siliconised, contributing to improved patient application.

InJentle™ has been designed with a range of additional benefits. For example, the special geometry of the glass barrel does not require the use of any tungsten during the glass forming process, making the syringe completely tungsten-free. Although the syringe has been designed with these special features, it is delivered with standard nests and tubs so that it can be filled on standard filling lines.

Press release from Cambridge Consultants: Introducing the SCHOTT InJentle™ syringe - improved stability for sensitive drugs...

SCHOTT product announcement: New Innovative Staked Needle Syringe SCHOTT InJentle™ - Drug Friendly, Patient Friendly...

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Tuesday, January 26, 2010

Therapeutic Lung Flute Cleared as Cough Assistance Device

Coughing up sputum is a popular activity among patients living with lung conditions like chronic obstructive pulmonary disease (COPD) and chronic bronchitis. To effectively dislodge the gunk patients tend to put in a lot of energy and volume into their coughs, a process too difficult or uncomfortable for many already living with compromised lungs. The Lung Flute, which essentially plays deep bass music to the respiratory tree, has just received FDA clearance to be used as a therapeutic at-home sputum dislodging assistance device. All you do is blow into it and the Mylar reed inside vibrates with a frequency that supposedly induces resonance of the sputum, shaking it apart and making it easier to cough it all up. Medical Acoustics, the Buffalo, New York company that developed the Lung Flute, is ready for sales and is making the device available early next month.

The application follows the successful completion of a clinical trial at the University at Buffalo (SUNY) and the Western New York VA Medical Center during 2009. The clinical trial, led by principal investigator, Sanjay Sethi MD, was designed to demonstrate the safety and effectiveness of the Therapeutic Lung Flute®. The trial was completed successfully with the Lung Flute® meeting all primary and secondary endpoints among patients with chronic obstructive pulmonary disease (COPD) with chronic bronchitis. This simple, hand-held, reusable therapeutic device supplements the patient’s natural mucus clearing system by introducing low frequency sound waves into the lungs.

Product page: Lung Flute...

Press release: Medical Acoustics Receives FDA 510(k) Clearance of Therapeutic Lung Flute...

Flashbacks: Lung Flute Helps to Get The Sputum Out; The Lung Flute Cleared by FDA for Sputum Induction

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Corventis Gets US OK for Wireless Cardiac Arrhythmia Monitoring System

Corventis out of San Jose, CA won FDA 510(k) approval to market the NUVANT Mobile Cardiac Telemetry (MCT) System. The company's wireless technology revolves around the chest worn PiiX electrocardiograph, a high precision single lead ECG, which sends readings to a mobile phone based device for further transmission of the data to a hosted application for clinician's access.

The NUVANT Mobile Cardiac Telemetry System is the second product launched from the Corventis portfolio of wireless cardiovascular solutions. Designed with a specific focus on ambulatory arrhythmia monitoring, the NUVANT MCT System leverages the low profile form factor, advanced algorithms and multi-sensor capabilities of the PiiX wearable platform to enable continuous monitoring for a broad set of arrhythmias, including atrial fibrillation, as well as patient falls that may be associated with arrhythmias. Patients can also trigger the collection of an electrocardiogram (ECG), on-demand, upon experiencing symptoms, further aiding in the correlation of symptoms with the ECG.

All ECGs are promptly transmitted to the Corventis Monitoring Center via the wireless-enabled zLink, for review and response by trained cardiographic technicians. Physicians receive prompt notification of urgent events as well as actionable information in the form of Episode Reports, Daily Reports and End of Use Reports via fax, email and/or the secure www.corventis.com website. Using this information, a physician can diagnose symptomatic and asymptomatic cardiac arrhythmias and proactively manage patients remotely from anywhere across the globe.

Press release: CORVENTIS ANNOUNCES FDA CLEARANCE AND US LAUNCH OF THE NUVANT™ MOBILE CARDIAC TELEMETRY SYSTEM...

Product page: NUVANT™ Mobile Cardiac Telemetry (MCT) System

Flashbacks: Piix Wireless Home Cardiac Monitoring to Undergo Randomized Trial; PiiX Monitors for Signs of Decompensated Heart Failure

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SUMAVEL DosePro Migraine Treatment Injection System Going on Sale in US

Having received FDA approval last July, Zogenix out of San Diego, California is bringing to market its SUMAVEL DosePro sumatriptan delivery system for the treatment of oncoming migraines and cluster headaches. The needle-free device delivers the drug subcutaneously, bringing both speed and efficacy when oral pills are a poor option.