We sought to evaluate the safety and efficacy of an electrical muscle stimulation (EMS) device in the improvement of muscle strength and toning of the upper extremities. This device, which is FDA-cleared as a two-channel muscle stimulator, provides up to eight electrodes with waveforms inducing muscle stimulation. Although a prior study demonstrated it is safe and effective for use in the abdomen, this system, which has electrodes specifically designed for the extremities, has not previously been evaluated in the upper extremities.
Forty-five subjects enrolled in the study to assess improvement in arm (i.e., bicep and tricep muscle) strength, and appearance following a protocol of treatments with this bioelectric muscle activation (BMA) device. All subjects received four 30-min EMS treatment sessions in Arm mode-twice weekly for 2 weeks and at least 48 h apart. Follow up visits were also scheduled 30- and 90-days after treatment. Strength was measured with a dynamometer device at baseline, at the final treatment session, and at the posttreatment 30- and 90-day assessment. Subject satisfaction was assessed gauging overall comfort of the treatment and satisfaction including willingness to recommend to others. The changes in strength between initial treatment and final treatment, as well as 30 and 90-day assessment were evaluated. Clinical photography at these visits was also assessed for each patient. Patients were instructed to not modify their normal exercise routine while participating in this study.
All 45 subjects completed the treatment protocol. Most patients showed an improvement in muscle strength from the initial to final treatment (i.e., the fourth treatment). Specifically, the maximum bicep strength increased by a mean of 7.5 lbs (22.83%, p = 0.006), while the average increased by a mean of 8.2 lbs (25.76%, p = 0.001) during this period. Similarly, the maximum tricep strength from initial to final treatment increased by a mean of 10.0 lbs (23.16%, p = 0.000), while the average increased by a mean of 9.6 lbs (27.12%, p = 0.000). Thirty days after the last treatment, the maximum bicep strength increased by a mean of 13.3 lbs (34.13%, p = 0.001) while the average increased by a mean of 13.6 lbs (37.05%, p = 0.000) during this period. Similarly, the maximum tricep strength from initial to 30 days postfinal treatment increased by a mean of 10.9 lbs (24.37%, p = 0.000), while the average increased by a mean of 10.5 lbs (29.37%, p = 0.000). Finally, 90 days after the last treatment, the maximum bicep strength increased by a mean of 19.4 lbs (48.4%, p = 0.000), while the average increased by a mean of 17.4 lbs (46.53%, p = 0.000) during this period. Similarly, the maximum tricep strength from initial to 90 days postfinal treatment increased by a mean of 10.8 lbs (27.12%, p = 0.000), while the average increased by a mean of 10.0 lbs (30.94%, p = 0.001).
This device was well tolerated and resulted in increased strength measurements in the upper extremities, as assessed by a dynamometer, which were sustained at 30 and 90 days.

BACKGROUND: Visceral adipose tissue (VAT), present in the abdominal cavity, oftentimes contributes to an unpleasant aesthetic appearance and can be correlated with serious health issues. High-intensity focused electromagnetic field (HIFEM) technology with synchronized radiofrequency (RF) was recently used for abdominal body shaping through subcutaneous fat reduction and muscle growth.
OBJECTIVE: This study aimed to assess the effect of HIFEM + RF technology on VAT tissue.
METHODS: Data of 16 men and 24 women (22-62 years, 21.2-34.3 kg/cm2 ) from the original study were retrospectively reviewed. All subjects received three 30-min HIFEM + RF abdominal treatments once weekly for three consecutive weeks. The VAT area was measured in the axial plane of MRI scans at two levels: L4-L5 vertebrae and 5 cm above this level. The VAT was identified, segmented, and calculated, yielding total area in square centimeters per scan at both specified levels.
RESULTS: By thoughtful review of the subject\'s post-treatment MRI scans, no other changes in the abdominal cavity were found except for VAT. The evaluation showed a VAT reduction of 17.8% (p < 0.001) on average at 3-month follow-up, maintaining the results up to 6 months (-17.3%). Averaging the values obtained from both measured levels, the VAT, occupied an area of 100.2 ± 73.3 cm2 at the baseline. At the 3-month follow-up, the subjects achieved an average reduction of 17.9 cm2 , preserving the results at 6 months (-17.6 ± 17.3 cm).
CONCLUSIONS: This retrospective analysis of MRI images objectively documented the effect of HIFEM + RF abdominal therapy on VAT. The data indicates considerable VAT reduction without serious adverse events following the HIFEM + RF procedure.

Lasers and energy-based technologies have been developed for genitourinary applications over the past several decades.
This consensus article aims to categorize the published articles and clinical trial data that culminated in protocol development of technology for genitourinary applications, and to develop consistent parameters in future clinical trials.
The published articles and clinical trials data on lasers and energy-based devices applied to genitourinary conditions were categorized according to device and condition and consensus developed on protocols and parameters.
The devices in genitourinary applications were classified as fractional lasers, radiofrequency and high-intensity focused electromagnetic field therapy. The consensus of the protocols and parameters based upon the published clinical trials of their application to the vaginal and urologic conditions associated with genitourinary syndrome of menopause was developed and organized according to device and condition.
The status of FDA clearances and future pathways are discussed.
This consensus article categorizes and presents the protocols and practices for the main classes of lasers and energy-based devices for genitourinary applications in future clinical trials.

UNASSIGNED: Several studies on the simultaneous use of high-intensity focused electromagnetic field (HIFEM) and radiofrequency (RF) have shown safety and effectiveness of fat reduction and muscle mass increases in other parts of the body. This study investigated HIFEM+RF procedure effect on muscle mass and adipose tissue in the upper arms.
UNASSIGNED: Thirty-four subjects enrolled in this multicentric study underwent four, 30-minute bilateral procedures over the upper arms spaced one week apart, with the device simultaneously emitting HIFEM and RF energies. Fat and m. triceps muscle tissue change was measured via magnetic resonance imaging at baseline, 1-month, and 3-month follow-up visits. Additionally, digital photographs, patient comfort, and satisfaction questionnaires were obtained. The trial is registered on ClinicalTrials.gov under NCT04596241.
UNASSIGNED: MRI images analysis showed significant improvement at both follow-up visits. At 1-month follow-up (n=28) patients showed 22.3 percent (-4.0±1.2 mm) decrease of average fat tissue, and 21.5 percent (+8.2±2.3 mm) muscle mass increase. Twenty-five patients completed the 3-month follow-up visit, with average decrease in fat tissue by 25.5 percent (-4.9±1.5 mm) and average increase in muscle mass by 23.9 percent (+8.9±2.01 mm). Analysis of questionnaires revealed high satisfaction with the results (84.64%), high comfort during the treatment (91.18%), and low VAS score (1.58±2.0), indicating painless procedure.
UNASSIGNED: Presented results demonstrate the safety and effectiveness of the HIFEM+RF procedure for muscle mass increase and fat reduction in the upper arm area. These findings correspond with the outcomes seen in other body parts.

BACKGROUND: Radiofrequency and HIFEM have been used as standalone modalities in body contouring. The novel device allows their synchronous emission simultaneously in a single applicator.
OBJECTIVE: This prelusive trial aims to investigate the safety and efficacy of such treatment when used on multiple body parts on the same day for a full-body remodeling.
METHODS: Three female subjects (21.0 ± 2.0 years) underwent 4 treatment sessions. The treatment was applied to the abdomen, saddlebags, inner thighs, and buttocks, during each visit, lasting 30 min for each site. The outcomes were assessed through examination of MRI images acquired at baseline and 3 months post-treatment. Fat and muscle thickness were measured at predefined locations. Weight and waist, hip, and thigh circumference records along with digital photographs were also taken.
RESULTS: Fat thickness measurement showed a reduction of 17.57 ± 3.22 mm in the saddlebag region, 12.43 ± 1.93 mm in inner thighs, and 10.65 ± 1.26 mm in the abdomen. The fat in the buttock region showed negligible changes. The muscle thickness increased on average by 2.98 ± 0.60 mm for rectus abdominis and 7.42 ± 1.56 mm for gluteus maximus. The circumferential reduction was also observed on the waist (7.83 ± 2.25 cm), at the level of outer thighs (2.83 ± 1.53 cm), and inner thighs (3.58 ± 1.84 cm). Digital photographs showed noticeable improvement in the overall body appearance. The treatments were safe, and no side effects were noted.
CONCLUSIONS: The preliminary outcomes indicate that the procedure delivering HIFEM and RF simultaneously on multiple body areas on the same day could be an effective and comfortable treatment for fat reduction on multiple body parts, thickening of underlying muscles, and overall improved aesthetic appearance.

BACKGROUND: Inevitable signs of aging are especially noticeable in middle to elder age when stretch marks, loose skin, cellulite, and body-contour changes naturally appear.
OBJECTIVE: To verify efficacy of high-intensity focused electromagnetic field (HIFEM), radiofrequency (RF), and Targeted Pressure Energy (TPE) combination treatment to address unfavorable changes in skin, fat, and muscle tissue.
METHODS: The device simultaneously emitting monopolar RF and TPE energies was consecutively combined with simultaneous HIFEM+RF procedure in 32 subjects (21-64 years, 17.4-33.5 kg/m2 ) for treatment of thighs (N = 15; back, inner, or front), buttocks/saddlebags (N = 7), abdomen (N = 8), and upper arms (N = 2). All patients underwent four weekly, combined treatments of 30-min HIFEM+RF procedure followed by 15-30 min RF+TPE, depending on treatment area. Circumferential measurements, digital photographs, subject satisfaction, and comfort questionnaires were assessed up to 3-months post-treatment.
RESULTS: Majority of participants found treatments comfortable, no adverse events occurred. Subjects showed substantial improvement in all treated areas from 1-month follow-up. Combination of HIFEM+RF, monopolar RF, and TPE resulted in significant circumference decrease. Generally, more pronounced results were seen at 3 months when subjects showed -5.2 cm on abdomen, -3.0 cm on thighs, and -5.5 cm on saddlebags, respectively. Ninety-four percent of subjects were satisfied with treatment results, most noticed improvement in cellulite, skin laxity, and muscle definition.
CONCLUSIONS: Results showed high patient satisfaction and efficacy in improving body contour and skin quality. Combining simultaneous HIFEM+RF procedure with simultaneous monopolar RF+TPE treatments considerably enhanced body contour and skin tissue. The procedure proved versatile and may effectively treat multiple body parts.

Energy-based devices extend the indications of traditional procedures in male body contouring. Devices currently available in this space may be noninvasive or minimally invasive. These devices use heat to destroy fat or tighten soft tissue and electromagnetic energy to build muscle mass. Thoughtful deployment of these technologies in isolation or in combination with each other or more traditional approaches can improve outcomes in male body contouring without an increase in scar burden. Patient selection and education are essential in maximizing satisfaction with these procedures.

BACKGROUND: High-intensity electromagnetic field procedure (HIFEM) is an effective tool for body shaping and muscle toning. Radiofrequency (RF) combined with targeted pressure energy (TPE) provides the solution for skin laxity and cellulite.
OBJECTIVE: To document the effect of consecutive use of HIFEM, RF, and TPE for treatment of abdomen and buttocks.
METHODS: Fifteen subjects (44.3 ± 14.2 years, 22.3 ± 2.3 kg/m2 ) finished treatments and consequent follow-ups. They were treated over the abdomen (Group 1, N = 7) or buttocks (Group 2, N = 8), receiving four treatment procedures consisting of HIFEM treatment administered first, immediately followed by the simultaneous RF & TPE treatment. Each session took approximately 50 min (30 min of HIFEM; up to 20 min of RF & TPE) depending on the treated area. Study outcomes were assessed by the circumference measurement, satisfaction and comfort questionnaires, and digital photographs.
RESULTS: Combined treatments were safe and comfortable. At 1 month, the abdominal circumference significantly decreased by 4.4 cm, while buttocks showed a significant increase by 1.0 cm. The abdomen (-4.1 cm) and buttocks (+1.2 cm) circumference results were sustained for three months without a significant decline. Satisfaction was high in both groups (93.3%) since most subjects noted that the appearance of the treated area has been improved, referring to both body sculpting and skin appearance.
CONCLUSIONS: The consecutive application of HIFEM, RF, and TPE treatments noticeably improved the appearance of the abdomen and buttocks. Subjects showed enhancement of abdominal body contour, buttock lifting, and improved skin quality manifested by reduced skin laxity and cellulite.

OBJECTIVE: This study evaluated the efficacy of a novel treatment method utilizing high-intensity focused electromagnetic field (HIFEM) in reducing fat and strengthening the muscles in the abdominal and gluteal areas. METHODS: A total of 14 patients, aged 23 to 49 years (mean: 33.2 years) received four treatments on the abdomen and/or buttocks, each lasting for 30 minutes. Ultrasound imaging was performed at baseline, immediately post-treatment, and eight weeks after the last treatment to examine the changes in thickness of the rectus abdominis and subcutaneous fat. Additionally, waist circumference, digital photographs, and patient satisfaction were collected at the same time points. The improvement in digital images was evaluated by practitioners and the patients themselves. RESULTS: Two months after the treatments, ultrasound measurements showed, on average, a 15.7-percent reduction of subcutaneous adipose tissue and an average increase in the thickness of the rectus abdominis muscle by 26.1 percent. The abdominal circumference of the treated patients showed an average decrease of 2.84 centimeters. Immediately following the final session, the patient\'s satisfaction was 87.5 percent; eight weeks later, it was 100 percent. During the patient evaluation of photographs, 25 percent of the patients rated their appearance as improved, 66.7 percent as significantly improved, and 8.3 percent as greatly improved. Using the Global Aesthetic Improvement Scale, the medical practitioners rated the patients as 100-percent improved. No relevant side effects of the treatment were documented. CONCLUSION: The data collected on the HIFEM procedure evaluated here are in line with the results from clinical studies and applications of this treatment in the United States. These results support the efficacy and tolerability of the HIFEM procedure. The treatment achieved high doctor and patient satisfaction.

BACKGROUND: Radiofrequency (RF) is commonly recognized treatment option for fat reduction, utilizing heat-induced adipocyte deletion. HIFEM treatment has been proven to be an effective tool for body shaping.
OBJECTIVE: To document the structural changes in human subcutaneous tissue induced by the combination of RF treatment with the HIFEM procedure.
METHODS: Four subjects (51.50 ± 6.35 years, 22.59 ± 3.21 kg/m2 ) received three 30-minute abdominal treatments consisting of RF therapy and HIFEM. One subject (57 years, 23.60 kg/m2 ) served as a control. Punch biopsies were collected at baseline, 1-week, and 1-month post-treatment. Samples were sliced and stained with H&E. Waist circumference, digital photographs, satisfaction, and therapy comfort were assessed. Subjects were monitored for any adverse event, and fat temperatures were measured.
RESULTS: Baseline samples showed a healthy appearance of adipocytes, composed of round-shaped unilocular cells of uniform size. At follow-up, treated adipocytes demonstrated nuclear and shape changes with consequent fat reduction. Adipocytes were found to be flattened/shrunken and of smaller size (-33.5% at 1 week; -31.7% at 1-month) along with occasional ruptures of the cytoplasmic membrane. In contrast to baseline, pyknotic nuclei with condensed nuclear chromatin were seen at 1-week and 1-month post-treatment. The control samples showed no treatment-related changes. Waist circumference decreased by an average of 2.20 cm in the treated patients. No adverse events were observed. The fat temperature reached 42-45°C, during treatment; the therapy was comfortable with high patient satisfaction.
CONCLUSIONS: Results suggest the efficacy and safety of the therapy combining RF and HIFEM. The adipocyte deletion and shrinkage resulted in overall reduction of fat tissue.