Dermatology Archive

Friday, January 22, 2010

Michelson's OCT Skin Scanner Gets Green Light in US


Michelson Diagnostics of London, UK has received FDA clearance to market the VivoSight optical coherence tomography (OCT) scanner in the US. The device, which uses a class I laser to shine light through tissue, is intended for use by dermatologists for analyzing skin tissue and lesions within the skin up to a depth of 2 millimeters.

From a Michelson press release:

VivoSight is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.

VivoSight is the first Fourier-Domain OCT scanner to receive FDA 510(k) clearance, outside of the field of ophthalmology. The patented ‘Multi-Beam OCT’ technology provides sub-surface images of tissue at far higher resolution than is possible with existing technologies such as ultrasound, CT or MRI, in 2D and 3D and in real time, using an easy-to-use lightweight hand-held probe.

From the VivoSight brochure:

The VivoSight scanner uses Multi-Beam Optical Coherence Tomography (OCT), a revolutionary laser-based imaging modality that provides images of surface tissue at extraordinarily high resolution – better than 7.5 μm lateral and 10 μm vertical resolution – far higher than is possible with other modalities, revealing previously hidden details of tissue microstructure.

VivoSight with ‘topical’ hand-held probe is designed to enable capture of images of surface tissue microstructure to a depth of up to 2 mm. The probe is positioned over the tissue and can capture either 2D or 3D images of a 5 mm square region. Tissue microstructure features such as epidermis, dermis and sub-layers can be imaged, as can subsurface blood vessels.

Light, ergonomically designed, wipe-clean probe, with adjustable ‘stand-off’ to enable the user to maintain a correct focus distance. The probe utilizes the Michelson Diagnostics’ patented Multi-Beam OCT optics for high resolution images, a visible red spot to aim the scan, and an X-Y (3D) scanning capability.

Press release: VivoSight OCT scanner Receives FDA 510(k) Clearance...

Product page: VivoSight OCT Scanner...

Flashback: Multi-Beam OTC Probe From Michelson Announced

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Tuesday, November 17, 2009

Smartscope for Normalized Dermatology Picture Taking


In the last few years, dermatologists have begun using standard digital cameras to photograph skin conditions for documentation and analysis. A major drawback to this approach is the difficulty in standardizing lighting conditions, camera angles, and other parameters that can affect how the image turns out. The newly released Smartscope from Optomed out of Oulu, Finland takes away many of these uncertainties so that all images are taken at the same distance, lighting conditions, and optical settings.

The Smartscope is a cordless, hand-held digital imaging device that measures and documents skin lesions for use in diagnosing and monitoring skin diseases. A more accurate and user-friendly alternative to standard digital cameras, the Smartscope uses LED illumination to produce consistent, reliable images, which along with measurements and annotations, can be easily transferred to and stored in software that is compatible with electronic medical records. High-resolution images and detailed information captured with the Smartscope can also be printed for the patient or used in case studies submitted to medical journals.

Product page: Optomed Smartscope M3-1 ...

Smartscope brochure...

Press release: New Device Improves Quality of Imaging, Patient Experience

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Monday, October 5, 2009

New Melanoma Radioactive PET Imaging Agent Discovered

A collaboration of Australian scientists has identified a new imaging radiotracer as an excellent PET contrast agent for melanoma in laboratory mice. The so called [18F]N-(2-(Diethylamino)ethyl)-6-fluoronicotinamide is now scheduled to begin clinical trials sometime next year, according to the press release by the American Chemical Society.

From the abstract in Journal of Medicinal Chemistry:

The high melanoma uptake and rapid body clearance displayed by our series of [123I]iodonicotinamides prompted the development of [18F]N-(2-(diethylamino)ethyl)-6-fluoronicotinamide ([18F]2), a novel radiotracer for PET melanoma imaging. Significantly, unlike fluorobenzoates, [18F]fluorine incorporation on the nicotinamide ring is one step, facile, and high yielding. [18F]2 displayed high tumor uptake, rapid body clearance via predominantly renal excretion, and is currently being evaluated in preclinical studies for progression into clinical trials to assess the responsiveness of therapeutic agents.

Image: [18F]2 PET image analysis of murine melanoma. (A) Whole body and (B) transaxial PET images of a C57BL/J6 black mouse bearing a B16F0 tumor allograft (right flank) at 1 h postinjection of [18F]2. (C) Autoradiographic and (D) photographic images of [18F]2 uptake in melanotic areas of a B16F0 tumor frozen section from a 1 h autoradiographic acquisition of [18F]fluorine disintegrations.

Press statement by the American Chemical Society: A potential new imaging agent for early diagnosis of most serious skin cancer...

Full article in Journal of Medicinal Chemistry: Discovery of [18F]N-(2-(Diethylamino)ethyl)-6-fluoronicotinamide: A Melanoma Positron Emission Tomography Imaging Radiotracer with High Tumor to Body Contrast Ratio and Rapid Renal Clearance

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Wednesday, August 19, 2009

Melanoscan Time Lapse Total Immersion Photo Technology Helps Spot Dangerous Skin Lesions Over Time


Via the Connecticut Post we learn of an automatic dermatologist's eye that can spot minor changes in skin coloration over time. The high tech device, called Melanoscan®, works on a simple principle of photographing the entire body using 25 cameras from different angles during repeat visits, and watching for changes between scans. Currently, typical visits to the dermatologist require the physician to do visual inspections of the patient, a difficult process where noticing small changes over time is critical for diagnosis. To assess the effectiveness of the Melanoscan, a study was conducted the results of which have recently been published showing that the device can spot melanomas by up to two years earlier than the trained naked eye.

Abstract in Dermatology Online Journal: Melanoma screening with serial whole body photographic change detection using Melanoscan® technology...

More from Connecticut Post...

Link: Melanoscan technology overview...

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Thursday, August 6, 2009

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

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)...

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Wednesday, July 22, 2009

CellScope, a "Mobile Phone Based Clinical Microscopy for Global Health Applications"


Investigators from UCSF and UC Berkeley have just published an article at PloS ONE that discusses applicability data and design of a newly developed microscope-enabled mobile phone system, dubbed CellScope. We have covered CellScope on our pages before. The goal of this research is to equip clinicians with a small and cheap technology to image microorganisms and pathology specimens in remote places, for an instant diagnosis or for transmission of images to a central location, such as a regional medical center.


The engineers attached compact microscope lenses to a holder fitted to a cell phone. Using samples of infected blood and sputum, the researchers were able to use the camera phone to capture bright field images of Plasmodium falciparum, the parasite that causes malaria in humans, and sickle-shaped red blood cells. They were also able to take fluorescent images of Mycobacterium tuberculosis, the bacterial culprit that causes TB in humans. Moreover, the researchers showed that the TB bacteria could be automatically counted using image analysis software.

The engineers had previously shown that a portable microscope mounted on a mobile phone could be used for bright field microscopy, which uses simple white light — such as from a bulb or sunlight — to illuminate samples. The latest development adds to the repertoire fluorescent microscopy, in which a special dye emits a specific fluorescent wavelength to tag a target - such as a parasite, bacteria or cell - in the sample.

The researchers used filters to block out background light and to restrict the light source, a simple light-emitting diode (LED), to the 460 nanometer wavelength necessary to excite the green fluorescent dye in the TB-infected blood. Using an off-the-shelf phone with a 3.2 megapixel camera, they were able to achieve a spatial resolution of 1.2 micrometers. In comparison, a human red blood cell is about 7 micrometers in diameter.

The researchers pointed out that while fluorescent microscopes include additional parts, less training is needed to interpret fluorescent images. Instead of sorting out pathogens from normal cells in the images from standard light microscopes, health workers simply need to look for something the right size and shape to light up on the screen.

Article in PLoS ONE: Mobile Phone Based Clinical Microscopy for Global Health Applications...

Press release with video of the microscope in action: UC Berkeley researchers bring fluorescent imaging to mobile phones for low-cost screening in the field...

Side image: Fluorescent image of TB bacteria taken by the CellScope.

Flashback: CellScope for Rural Microscopy On The Go

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Tuesday, March 10, 2009

Genetic Test for Finasteride Response


HairDX, LLC, a subsidiary of PharmaGenoma, Inc., is introducing a genetic test to predict clinical response to finasteride, a commonly prescribed hair loss medication (also known as Propecia, amongst other names). Finasteride works by blocking the production of the androgen responsible for hair loss in androgenic alopecia. Use of the medication carries a risk of sexual side effects and since hair grows in cycles, it often takes months to determine if it is working. The genetic test, introduced at the annual meeting of The American Academy of Dermatology, provides patients with a score that predicts their response to finasteride. The test works by identifying certain nucleoside variants on the androgen receptor gene that determine androgen sensitivity. You can think about putting your toupee away for $199.

From the press release:

The HairDX (RxR) Genetic Test for Finasteride Response will help doctors predetermine if patients will have a subtle, moderate, or great treatment response to Finasteride, allowing the physician to provide patients with the best treatment regimen to save their hair...

[The test] provides doctors with a patient score, called the CAG repeat score. “A smaller CAG test score is associated with an increased response to Finasteride for treatment of Androgenetic Alopecia,” says Dr. Sharon Keene, HairDX Chief Medical Officer. “Scientists discovered that among men that had the best response to Finasteride approximately 70% had a CAG score below 22 while among men that had a subtle response to Finasteride approximately 70% had a CAG score above 22.”

Press release: HairDX Introduces Genetic Test For Finasteride Response (.pdf)...

Product page: HairDX...

NOTE: Please say big hello to our new editor. Sean Duffy is a graduate of Columbia in neuroscience, who is starting Harvard Medical School this August. For now he will be blogging with us. This is his first post.

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Thursday, February 5, 2009

Gold Nanoparticles Help in Fighting Skin Cancer

goldnanopartc.jpgUniversity of Texas scientists have created a technique that utilizes gold nanoparticles to increase the efficiency of photothermal ablation when treating melanoma. During photothermal ablation, infrared light is used to burn suspected tumor tissue, but often the healthy stuff gets cooked too. Now, by injecting highly light absorbing gold nanoparticles that have a high affinity for tumors, the efficiency and specificity of photothermal ablation is increased.

From the University of Texas M. D. Anderson Cancer Center:

With hollow gold nanospheres inside melanoma cells, photothermal ablation destroyed tumors in mice with a laser light dose that was 12 percent of the dose required when the nanospheres aren't applied, Li [Chun Li, Ph.D., professor in M. D. Anderson's Department of Experimental Diagnostic Imaging] and colleagues report. Such a low dose is more likely to spare surrounding tissue.

Injected, untargeted nanoparticles accumulate in tumors because they are so small that they fit through the larger pores of abnormal blood vessels that nourish cancer, Li said. This "passive targeting" delivers a low dose of nanoparticles and concentrates them near the cell's vasculature.

The researchers packaged hollow, spherical gold nanospheres with a peptide - a small compound composed of amino acids - that binds to the melanocortin type 1 receptor, which is overly abundant in melanoma cells. They first treated melanoma cells in culture and later injected both targeted and untargeted nanospheres into mice with melanoma, then applied near-infrared light.

Fluorescent tagging of the targeted nanospheres showed that they were embedded in cultured melanoma cells, while hollow gold nanospheres without the targeting peptide were not. The targeted nanospheres were actively drawn into the cells through the cell membrane.

When the researchers beamed near-infrared light onto treated cultures, most cells with targeted nanospheres died, and almost all of those left were irreparably damaged. Only a small fraction of cells treated with untargeted nanospheres died. Cells treated only with near-infrared light or only with the nanospheres were undamaged.

Most of the targeted nanospheres in the treated mice gathered in the tumor, with smaller amounts found in the liver and spleen. Most of the untargeted nanospheres gathered in the spleen, then in the liver and then the tumor, demonstrating the selectivity and importance of targeting.

In another group of mice, near-infrared light beamed into tumors with targeted nanospheres destroyed 66 percent of the tumors, but only destroyed 7.9 percent of tumors treated with untargeted nanospheres.

The researchers used F-18-labeled glucose to monitor tumor activity by observing how much glucose it metabolized. This action "lights up" the tumor for positron emission tomography (PET) imaging. Tumors treated with targeted shells largely went dark.

Press release: Targeted Nanospheres Find, Penetrate, then Fuel Burning of Melanoma

Image: Gold nanoparticles from an unrelated project. Credit Annie Cavanagh, Wellcome Images

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Wednesday, January 14, 2009

Skin Cancer Diagnosis Minus The Biopsy

Research scientists at the Vanderbilt Medical Center are developing a sensor that can identify the presence of carcinoma based on how light is attenuated when it traverses within a patient's skin.

Here's a video report from Vanderbilt:

Press release: Diagnosing Skin Cancer Without Biopsy

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Wednesday, January 7, 2009

Infrared Pathogen Killing Device Wins Approval Expansion from FDA


Nomir Medical Technologies of Waltham, Mass. has received FDA clearance for the company's Noveon® Dual-Wavelength Device to be used in "procedures of the skin, subcutaneous tissues and nasal passages, for applications in podiatry, dermatology, plastic surgery, and otolaryngology." Using two near-infrared low energy light beams, the device can kill MRSA, toe nail fungus, and other common pathogens.

From the press release:

President and CEO Richard Burtt commented, “The granting of this 510(k) approval is another significant milestone in Nomir’s regulatory process, which we have been pursuing rigorously, and paves the way for future 510(k) multi-site, disease-specific applications. The Noveon is a light-based system that photo-biologically targets the elimination of bacterial and fungal infections through a unique, near-infrared, photo-inactivation effect, while preserving healthy tissue and promoting recovery. This new FDA clearance highlights the continued success of the Nomir team and its implementation of our regulatory plans for commercialization of our unique photo-biological, anti-infective Noveon system.”

Nomir’s Chief Scientific Officer, Dr. Eric Bornstein, added, “Noveon has also demonstrated its success in the clinic, eliminating MRSA infection in the nose, reversing microbial resistance to common antibiotics, and effecting complete photo-inactivation of toe nail fungus, all at safe energy densities and temperatures. We believe these positive results, combined with our successful regulatory strategy, will make Noveon a potentially attractive option in the future to clinicians treating an array of infections.”

Nomir has completed two IRB human studies with Noveon against methicillin-resistant Staphylococcus aureus (MRSA) carriage and infection in the nares (nose). Based on positive data from these studies, Nomir is initiating a pilot study with Noveon for the reduction of bioburden in diabetic foot ulcers.

After multiple IRB human pilot studies with Noveon against onychomycosis (toe nail fungus), Nomir initiated an FDA pivotal study of its Noveon device for this indication in May 2008, an integral step for FDA clearance of the application.

Press release: Nomir Medical Announces Second FDA 510(k) Clearance of its Noveon® Dual-Wavelength Device...

Nomir technology page...

Flashback: A Bright Light Against Dark Matter: A New Device to Fight Toe Nail Fungus

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Tuesday, October 21, 2008

"MedGadgetitis" Can Present With a Rash!

We love our gadgets, and we know our readers do too! But when our passions start to cause rashes, it's time to step back and reevaluate. OK, that's long enough... The British Association of Dermatologists (BAD) recently released a report warning of contact dermatitis from mobile phone use. It appears the rash is brought upon by nickel in some cellphones' metallic casings.

BAD has dubbed the rash "mobile phone dermatitis" but we think MedGadgetitis is not only easier to remember, but it's catchier and shamelessly promotes our website. We hope this catches on before the dermatologists lobby for "BAD Rash", as this could lead to all kinds of problems when trying to explain it to your partner.

Lionel Bercovitch, MD, and John Luo of Brown's Warren Alpert Medical School noticed a pattern with phones containing nickel and published their work in the January 2008 edition of the CMAJ (Canadian Medical Association Journal).


Picture and case from the CMAJ (January 1, 2008)

The case:

An 18-year-old male presented with pruritic lichenified dermatitis on his lower abdomen and eczematous dermatitis on his extremities, flanks and face that had lasted several weeks. We suspected his belt buckle had led to allergic contact dermatitis with subsequent autoeczematization. Patch testing using the expanded North American Contact Dermatitis Group allergen battery of 65 allergens1 disclosed an edematous and papulovesicular reaction to nickel at 72 hours. The patient had no other positive reactions, nor did he react to other metals tested, including gold, cobalt, chromium, copper and palladium.

The patient suspected that his recurrent facial dermatitis was related to contact with the headset of his cellphone. We spot tested both the antenna and the headset for free nickel. The test of the antenna, which was plastic coated with metallic paint, was negative. The test of the headset was strongly positive for free nickel. The patient began using a cellphone that contained no nickel, and his facial dermatitis cleared. He decided to resume using his old cellphone to confirm that it had caused his dermatitis and the eruption recurred.

CMAJ Article: Cellphone contact dermatitis with nickel allergy; CMAJ • January 1, 2008; 178 (1)

Press Release: British Association of Dermatologists

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Monday, August 4, 2008

Handheld Skin Resurfacing Device Gets FDA OK

Alma Lasers, a Buffalo Grove, IL affiliate of an Israeli company with the same name, is reporting that its fractional ablative device, the Pixel® CO2 OMNIFIT, has been cleared by the FDA for marketing in the United States.

The following is from the press release:

The Pixel CO2 OMNIFIT is Alma’s newest offering in skin rejuvenation and it is an upgrade to physicians’ existing CO2 skin resurfacing lasers. It is designed to provide patients with impressive results with just a fraction of the downtime compared to current treatments, and for significantly less money than replacing their current laser.

The Pixel CO2 OMNIFIT handpiece fits onto most existing CO2 lasers and is designed to deliver a high degree of efficacy without the side effects or significant downtime associated with traditional CO2 resurfacing. By combining Alma’s proprietary and proven Pixel fractional technology with a standard CO2 resurfacing laser, the new Pixel CO2 OMNIFIT delivers a supremely effective treatment for aged, photo-damaged, and acne-scarred skin with minimal patient redness, irritation or downtime...

The Pixel CO2 OMNIFIT handpiece takes ablative patient downtime from 30 days to approximately three, making the procedure as appealing as many non-invasive approaches available to today’s busy patients.

And here's a product brochure:

Read this document on Scribd: Pixel CO2 Omnifit Brochure

Product page: Pixel C02 OMNIFIT Fractionated CO2 Adapter From Alma Lasers...

Press release: Alma Lasers Announces FDA Clearance of the Pixel® CO2 OMNIFIT Handpiece...

Flashback: HarmonyXL, Aesthetic Dermatologist's Multi-Tool

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Tuesday, June 3, 2008

HarmonyXL, Aesthetic Dermatologist's Multi-Tool

Alma Lasers (Buffalo Grove, IL) has received approval from the FDA to market the company's laser and light device for various aesthetic and medical skin treatments. Having no dermatologists on staff, we are somewhat perplexed by the lavish capabilities described in the press release:

The HarmonyXL device is the most comprehensive and versatile platform to enter the medical and aesthetic industry, as it is the first to combine lasers, pulsed light, near-infrared, LED and UVB technologies with multiple exchangeable handpieces to ensure easy and effective singular and combined therapeutic treatment. The HarmonyXL also accommodates new versions of Alma’s unique Advanced Fluorescence Technology (AFT) and several different laser technologies. Compared to its successful predecessor, HarmonyXL delivers higher energy and is the first Harmony model to incorporate Alma’s proprietary IN-MotionTM technology, which delivers effective energy with virtually no discomfort over a range of applications. Additionally, the HarmonyXL exclusively offers high-power Pixel® 2940 technology – a breakthrough for fractionated skin resurfacing treatments.

Press release: Alma Lasers Announces FDA Clearance of the HarmonyXL

Product page: HarmonyXL

Product brochure (.pdf)...

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Tuesday, May 20, 2008

Wallet-Size Mulitspectral Imaging System for Skin Diagnostics

Georgia Tech is reporting that its scientists at the university's Center for Assistive Technology and Environmental Access (CATEA) developed a handheld low-cost technology to scan any surface for abnormalities. The investigators were actually working on a system that can empower "front line clinicians with no specialized training to detect and assess, in real-time, the severity of bruises and erythema, regardless of patient skin pigmentation or available lighting." Now the hope is that such a system can be used for detection and characterization of such things as melanoma, other forms of skin CA, or decubitus ulcers.

More about technology:

Researchers at Georgia Tech have developed a narrowband filter mosaic that will expand the uses and functionality of multispectral imaging—a technology that enables subsurface characterization...

In addition to this application, the filter could potentially offer a reliabile, low-cost method to instantaneously classify military targets, sort produce, inspect product quality in manufacturing, detect contamination in foods, perform remote sensing in mining, monitor atmospheric composition in environmental engineering and diagnose early stage cancer and tumors.

The technology was developed in Georgia Tech’s Center for Assistive Technology and Environmental Access (CATEA) as part of a project to design a portable erythema and bruise-detection technology that will enhance early prevention and diagnosis of pressure ulcers, a secondary complication for people with impaired mobility and sensation.

Currently, clinical assessment of bruises is subjective and unreliable, especially when on persons with darkly pigmented skin. Improved imaging can lead to earlier intervention which is vital in cases of suspected physical abuse. Similarly, early detection of erythema can trigger preventive care that can stop progression into pressure ulcers.

Pressure ulcers are a serious secondary complication for people with impaired mobility and sensation. Annual Medicare spending is conservatively approximated at $1.34 billion for the treatment of pressure ulcers. Early detection of erythema can prevent progression into more serious Stage III or Stage IV pressure ulcers.

The filter mosaic can be conveniently laminated with imaging sensors used in digital cameras. With a patent pending, CATEA researchers are currently seeking collaborative or financial support to further develop and design the device.

“Although multispectral imaging has matured into a technology with applications in many fields, clinicians and practitioners in these fields have generally stayed away from it due to extremely high costs and lack of portability,” said Dr. Stephen Sprigle, director of CATEA and professor of industrial design and human physiology. “Now, the possibilities are plentiful.”

Press release: New Technology Puts Biomedical Imaging in Palm of Hands...

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Friday, May 16, 2008

A Bright Light Against Dark Matter: A New Device to Fight Toe Nail Fungus


Nomir Medical Technologies of Waltham, Mass. is reporting that it plans to initiate a study of its Noveon® direct optical energy device. The company believes that its light-based system can target for elimination a number of bacterial and fungal infections, while also "promoting healthy tissue recovery." The first target on the company's list is everyone's favorite onychomycosis (toenail fungus). The representative for the company tells Medgadget that the device "utilizes two discrete near-infrared wavelengths at low power-- it is photobiologic in nature and doesn't use heat. Nomir is also developing products based off of its optical energy platform for MRSA, periodontal disease, and diabetic foot ulcers (wound care) in addition to OM (onychomycosis)."

From the press release:

The primary objective of the trial is to test the efficacy and safety of Noveon in treating patients with onychomycosis (toenail fungus). The target population for this study is patients with toenail onychomycosis, as confirmed by culture, with the goal of gaining a new FDA approval to use the device for the treatment of onychomycosis.

“This pivotal trial initiation is a major step for Nomir, moving us closer to commercial launch of our first product utilizing our proprietary dual-wavelength optical energy technology,” stated Richard Burtt, CEO of Nomir Medical Technologies. “Noveon represents a novel treatment approach of using optical energy to address disease indications, such as onychomycosis, that are typically sub-optimally treated with traditional pharmaceutical drugs. In pilot studies, Noveon demonstrated 87% clinical improvements, and we are therefore hopeful for similarly positive outcomes from this investigation.”

In November 2007, Nomir received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to utilize Noveon during surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry, and otolaryngology. Nomir’s regulatory strategy accelerates the review process for the FDA by de-coupling the device clearance from the application clearance.

Forty evaluable subjects will be enrolled in the prospective, randomized, multi-site U.S. trial. It is expected that this will provide at least 30 evaluable subjects, two-thirds of which will be treated with Noveon and the remaining serving as controls. Study objectives include assessing clinical improvement and mycological decontamination of the treated area of the nail. Patients will receive four treatments over a four-month period and will be followed up to one year following the initial treatment to assess clinical improvement and mycological response.

Press release (.pdf)...

Nomir Medical Technologies...

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Monday, March 17, 2008

CellScope for Rural Microscopy On The Go


At the University of California Berkeley, a few handy researchers modified an off-the-shelf camera cellphone to produce a mobile microscope capable of 50x magnification. Coupled with the phone's natural ability to send out images, the device may help to virtually bring dermatologists, pathologists and oncologists to remote areas of the world.

Using Bluetooth, wi-fi and cellular networks, a phone needs no modification itself. Capable of 50x magnification today, the devices could provide twice that. A smaller prototype features its own light source.

"This could be useful even at home," suggests Fletcher [Associate Professor of Bioengineering at Berkeley --ed.], "where, for example, early warnings of a change in the shape of a mole could be sent to your clinician on a regular basis to monitor."

In addition, cancer patients could conduct their own blood cell counts that today require larger microscopes and particle counters.

Dr. Lam, Pediatric Oncologist at UCSF, is one of the grad students working on CellScope. He adds, "By no means do we think this is going to replace those large particle counters. It's just a good adjunct for the patient to have at home."

More, with video, from ABC...

Project page: Telemicroscopy for Disease Diagnosis...

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Wednesday, February 13, 2008

New Lasers for Better Skin

At the UT Southwestern Medical Center, dermatologists are employing a new carbon dioxide-based fractional laser for procedures like skin tightening, tattoo removal, and evening out differences in skin pigmentation.

“Fractional lasers are like aerating your lawn, where you have a bunch of holes in your lawn, but you have normal lawn in between. This allows for more rapid healing because intact, normal skin bridges the gap between the laser-induced injured skin,” said Dr. Jeffrey Kenkel, vice chairman of plastic surgery whose research involves the effects of lasers on tissue. “We can vary the distance between the holes, which has an effect on how much tissue we choose to treat. The treatment parameters are determined by what we are trying to accomplish for each of our patients.”

Dr. Kenkel, director of the Clinical Center for Cosmetic Laser Treatment and chief of plastic surgery at the Veterans Administration Medical Center at Dallas, said the technology potentially could be one of the last decade’s biggest advancements in the laser world.

“What’s appealing about carbon dioxide lasers is that not only can you get surface and deeper skin changes, but you get heat that’s deposited into the skin resulting in improvement in wrinkles and skin tightening,” said Dr. Kenkel.

Press release: Plastic surgeons deploy new laser for wrinkle removal, acne scarring, tattoo removal

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Monday, February 4, 2008

Matrix RF from Syneron

Israel's Syneron Medical Ltd. are at the annual American Academy of Dermatology meeting in San Antonio this week to show off the firm's skin ablation devices that include the newly released Matrix RF applicator.

The Matrix RF applicator utilizes Syneron's patented Bi-Polar Radio Frequency technology to provide effective and comfortable skin rejuvenation. The tunable applicator, which may be used on Syneron's eLight™, eLaser™ and eMax™ platforms, allows for the adjustment of ablation and coagulation settings to vary treatment depth and the proportion of skin treated in each session. The Matrix RF will also feature a single-use disposable. The Matrix RF is the second product in Syneron's series of elos fractional treatments, which currently includes the Matrix IR™ device. Like all of Syneron's specialized applicators, the Matrix RF will be sold as an upgrade to the elos platforms, to be used along with other Syneron applicators to expand the range of aesthetic treatments physicians can offer from each eSeries platform.

Press release: Syneron(TM) Previews Matrix RF(TM) Ablative Fractional Device and Laser-Assisted Lipolysis System at American Academy of Dermatology Annual Meeting

Syneron product page: Products

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Friday, February 1, 2008

Fraxel re:pair™ for Ablative Fractional Resurfacing™

Reliant Technologies, Inc will be showing off its new Fraxel re:pair™ laser for CO2 skin resurfacing at the American Academy of Dermotology meeting in San Antonio, which is starting today.

The Fraxel re:pair laser system, the result of two years of clinical research, represents a new category in skin rejuvenation: Ablative Fractional Resurfacing (AFRTM) treatment. It is the only device on the market that has received FDA clearance specifically for skin resurfacing with a fractional mode of delivery. “Ablative fractional skin resurfacing with the Fraxel re:pair laser is the biggest breakthrough for wrinkle removal in the last 10 years,” said Christopher Zachary, FRCP, chair of the Department of Dermatology, University of California at Irvine. “Results approach those we can achieve with a facelift, with very few complications and limited downtime. The Fraxel re:pair system produces significant tissue tightening, wrinkle reduction and textural improvement, both on and off the face.” The Fraxel re:pair laser is the industry’s only minimally invasive, ablative fractional laser system that delivers a full spectrum of aesthetic treatment from Fractional MicroDermAblation™(FMDA™)treatment to Fractional Deep Dermal Ablation™ (FDDA™) treatment. It is the only ablative resurfacing device capable of being operated by a single clinician, because of its built-in smoke evacuation system, and capable of treating at depths from 300 micrometers (µm) to 1.6 mm into the dermis, all in a single hand piece.

Product page: Fraxel re:pair

Press release: Reliant Technologies Announces World Premiere of Fraxel re:pair(TM) Laser: A New Class of Treatment Therapy for CO2 Laser Skin Resurfacing ...

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