Shedding light on the FDA's 510(k) approvals process: low-level laser therapy devices used in the treatment of androgenetic alopecia.

Introduction: Low-level laser therapy has demonstrated superior efficacy relative to other nonsurgical treatment options for the treatment of androgenetic alopecia. Methods: Records from a public U.S. FDA database for premarket approval of low-level laser therapy devices approved between January 1 2000 and July 15 2018 were reviewed. Results: 47 devices received 510(k) premarket approval, with an increasing number of devices available since 2007. More options are now available and product indications have expanded for use in a wider audience, including both men and women. Discussion: Growing recognition of lasers has led to an increasing number of devices available as well as innovative options in terms of design and convenience. In the past few years, these devices have adopted broader indications for use in both men and women. However, marketed indications have not been adequately explored and current devices on the market have the potential to mislead consumers.

Quantitative skin assessment using spatial frequency domain imaging (SFDI) in patients with or at high risk for pressure ulcers.

BACKGROUND AND OBJECTIVE: Pressure ulcers (PU) are a significant problem facing the health system in the United States. Here, we present preliminary case studies demonstrating feasibility of Spatial Frequency Domain Imaging (SFDI) to assess skin status in high-risk populations and pre-existing wounds. SFDI is a wide-field non-contact optical imaging technology that uses structured light to obtain tissue optical properties and of tissue constituents. This study aims to determine the fit of SFDI for PU care and determine the next steps. STUDY DESIGN/MATERIALS AND METHODS: Patients at risk for pressure ulcers were imaged using a near-infrared SFDI system. SFDI-derived images of tissue function (tissue hemoglobin, tissue oxygen saturation) and structure (tissue scattering) were then compared to each other as well as a blinded dermatologist's clinical impressions. RESULTS: Four case series were chosen to demonstrate the imaging capability of this technology. The first scenario demonstrates normal skin of three patients without skin breakdown with spatially uniform measures of tissue oxygen saturation, scattering, and blood volume. The second scenario demonstrates a stage II PU; the third case shows non-blanchable erythema of an unstageable PU; a fourth scenario is a clinically indistinguishable skin rash versus early stages of a PU. In all these cases, we observe spatial changes in tissue constituents (decrease in tissue oxygen saturation, increased blood pooling, decreased scattering). CONCLUSION: We have presented the first use of SFDI for pressure ulcer imaging and staging. This preliminary study demonstrates the feasibility of this optical technology to assess tissue oxygen saturation and blood volume status in a quantitative manner. With the proposed improvements in modeling and hardware, SFDI has potential to provide a means for pressure ulcer risk stratification, healing and staging. Lasers Surg. Med. 49:827-834, 2017 © 2017 Wiley Periodicals, Inc.

Feasibility of carotid artery PET/MRI in psoriasis patients.

We report our initial experience of performing integrated PET/MR imaging of the carotid arteries in psoriatic patients. Eleven patients with psoriasis and ten controls underwent carotid PET/MRI. Following injection of the FDG tracer, 3d T1w gradient echo sequence (atMR) was obtained for attenuation correction of PET data. High resolution images of carotid artery were then obtained, including pre-and post-contrast T1-w, T2-w and proton-density images as well as TOF images followed by PET imaging of the torso. From the fused axial PET/MRI, the arterial wall SUVmax and TBRmax was quantified in each slice. MRI images were also evaluated for vessel wall volume, plaque and internal composition. SUVmax and TBRmax were respectively, 1.72 ± 0.38 & 1.17 ± 0.27 in L- CCA, 1.75 ± 0.39 & 1.24 ± 0.19 in R-CCA, 1.59 ± 0.24 & 1.08 ± 0.14 in L-ICA and 1.62 ± 0.27 & 1.15 ± 0.17 in R-ICA in psoriatic patients and 1.74 ± 0.22 & 1.28 ± 0.44 in L- CCA, 1.74 ± 0.33 & 1.07 ± 0.28 in R-CCA, 1.78 ± 0.32 & 1.29 ± 0.39 in L-ICA and 1.60 ± 0.29 & 0.98 ± 0.25 in R-ICA in the controls. No discrete plaques were identified in any of the vessel segments in MRI. PET/MRI is feasible in evaluation of carotid arteries in psoriatic patients.

Updates on Therapeutic Strategies Against Candida (and Aspergillus) Biofilm Related Infections.

Fungal biofilm related infections are commonly associated with medical devices with biofilms contributing to the virulence of the involved fungal species. If infection does occur, removal of medical device is often warranted. However, this is not always possible. Moreover, biofilm associated infections are often resistant to antifungals and host immunity. Therefore, a need for new agents and strategies to combat these devastating infections is needed. Although no randomized clinical trials have been conducted or are likely to be conducted in the future, the Infectious Disease Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) utilized available published data and clinical experience of the infectious disease community to propose strategies to treat biofilm associated devise infections. In this chapter we describe the emerging therapies for biofilm related infections.