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)...

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...

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...

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...

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