There is interest in noninvasive devices that will improve the diagnosis of malignant skin lesions. One technique is dermatoscopy (dermoscopy, epiluminescence microscopy, in vivo cutaneous microscopy), which enables the clinician to perform direct microscopic examination of diagnostic features in pigmented skin lesions. Another approach is computer-based light imaging systems. These techniques have the potential to improve diagnostic accuracy for suspicious skin lesions and may increase the detection rate of malignant skin lesions and/or reduce the rate of unnecessary biopsies. The evidence for dermatoscopy in patients who have lesions suspicious of melanoma includes a number of diagnostic accuracy studies and several meta-analyses. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. The literature suggests that dermatoscopy is more accurate than naked eye examination when used in the expert clinical setting. The available evidence from prospective randomized controlled trials (RCTs) and other studies suggests that dermatoscopy used by specialists may lead to a decrease in the number of benign lesions excised and, when used by primary care physicians, may lead to fewer benign lesions being referred to specialists. The number of studies on the impact of dermatoscopy on patient management and clinical outcomes remains limited. The evidence is insufficient to determine the effects of the technology on health outcomes. The evidence for computer-based optical diagnostic devices in patients who have lesions suspicious of melanoma includes several prospective diagnostic accuracy studies and a simulation study. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. In the diagnostic accuracy study, 10% of samples were not evaluable and the simulation study had a number of potential biases. There are no studies comparing patient management decisions and health outcomes with and without these devices. The evidence is insufficient to determine the effects of the technology on health outcomes. The evidence for dermatoscopy in patients who have pigmented lesions being monitored for suspicious changes consists of noncomparative studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. The available does not clearly indicate that dermatoscopy results in better patient management decisions. The evidence is insufficient to determine the effects of the technology on health outcomes. The evidence for computer-based optical diagnostic device in patients who have pigmented lesions being monitored for suspicious changes includes no published studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. The evidence is insufficient to determine the effects of the technology on health outcomes. The evidence for dermatoscopy and computer-based optical diagnostic devices in patients who have cancerous skin lesions referred for surgery includes 1 RCT and several observational studies. Relevant outcomes are overall survival, disease-specific survival, and treatment-related morbidity. The single RCT did not report superior outcomes using dermatoscopy compared with visual inspection or curettage. The published studies were all conducted outside of the United States and at least 2 did not use U.S. Food and Drug Administration‒approved devices. None addressed computer-based optical devices. The evidence is insufficient to determine the effects of the technology on health outcomes.

Immunotherapy in allergies requires regular injections of an allergen for months in order to reduce symptoms. It begins with small doses to avoid reactions and gradually increase by injecting once or twice a week until the patient develops immunity to the antigen. Once the maintenance dose is reached, the interval between injections can vary between two and six weeks. This regime can be maintained continuously for a few years if necessary. <a id="

Extracorporeal shock wave therapy (ESWT) is a noninvasive method used to treat pain with shock or sound waves directed from outside the body onto the area to be treated (eg, the heel in the case of plantar fasciitis). Shock waves are generated at high- or low-energy intensity, and treatment protocols can include more than 1 treatment. ESWT has been investigated for use in a variety of musculoskeletal conditions.

A prosthesis is an artificial substitute that replaces all or part of an organ of the body, or replaces all or part of the function of a part of the body that is not permanently functioning, that is absent, or exhibits evidence of malfunction. Prostheses of lower limbs can include a number of components, such as prosthetic feet, ankles, knees, knee-endoskeletal systems, socket inserts and suspensions, hip and ankle <a id="

Patient-controlled stretching devices are used at home to increase range of motion in patients who have impaired functional status due to decreased range of motion. We address 2 types of commercially available devices. Static progressive stretch devices (eg, Joint Active Systems, Static-Pro) provide low- to moderate-intensity stretching with a crank or ratchet that progressively increases the stretch within each session, and serial stretch devices (eg, End Range of Motion Improvement [ERMI] ) use hydraulics to alternate between periods of higher intensity stretch and relaxation.

The goal of the powered exoskeleton is to enable people who do not have volitional movement of their lower extremities to be able to fully bear weight while standing, to walk, and to navigate stairs. The devices have the potential to restore mobility and, thus, might improve functional status, quality of life, and health status for patients with spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, Guillain-Barré syndrome, and spina bifida.

Digital health technologies is a broad term that includes categories such as mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device, and include technologies intended for use as a medical product, in a medical product, as companion diagnostics, or as an adjunct to other medical products (devices, drugs, and biologics). The scope of this review includes only those digital technologies that are intended to be used for therapeutic application and meet the following 3 criteria: 1) Must meet the definition of "Software as a medical device" which states that software is intended to be used for a medical purpose, without being part of a hardware medical device or software that stores or transmits medical information. 2) Must have received marketing clearance or approval by the U.S. Food and Drug Administration (FDA) either through the de novo premarket process or 510(k) process or pre-market approval and 3) Must be prescribed by a healthcare provider.

Medical supplies that, due to their diagnostic or therapeutic characteristics, are essential for the effectiveness of the care plan ordered by the doctor for the treatment or diagnosis of the patient's illness or injury. <a id="

Negative pressure wound therapy (NPWT) involves the use of negative pressure or suction device to aspirate and remove fluids, debris, and infectious materials from the wound bed to promote the formation of granulation tissue and wound healing.

Pelvic floor stimulation is proposed as a nonsurgical treatment option for women and men with urinary or fecal incontinence. This approach involves either electrical stimulation of pelvic floor musculature or extracorporeal pulsed magnetic stimulation.

Antithrombotic prophylaxis is recommended for surgical patients at moderate-to-high risk of postoperative venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), based on the surgical procedure and/or patient characteristics. For some types of surgery (eg, major orthopedic surgery), there is a particularly high risk of VTE due to the nature of the procedure and the prolonged immobility during and after surgery. Common patient risk factors include increasing age, prior VTE, malignancy, pregnancy, and significant comorbidities. Increased risk of bleeding is a contraindication to anticoagulation, as are adverse events and allergic reactions. Limb compression devices have been used as an adjunct or alternative to anticoagulation in the home setting for patients in the postoperative period as a method to reduce VTEs.

Interferential current stimulation (IFS) is a type of electrical stimulation used to reduce pain. The technique has been proposed to decrease pain and increase function in patients with osteoarthritis and to treat other conditions such as constipation, irritable bowel syndrome, dyspepsia, and spasticity.

Cooling devices use chilled water to decrease the local temperature of tissue. There are a variety of cooling devices available, ranging from gravity-fed devices that manually fill with iced water, to motorized units that both cool and circulate chilled water. These devices are typically used when ice packs would normally be applied (eg, after orthopedic surgical procedures).

Tumor treating fields (TTF) therapy is a noninvasive technology intended to treat glioblastoma, malignant pleural mesothelioma, and non small cell lung cancer on an outpatient basis and at home using electrical fields. Glioblastoma multiforme (GBM) is the most common and deadly malignant brain tumor. It has a very poor prognosis and is associated with low quality of life during treatment. Malignant pleural mesothelioma is an aggressive tumor with few treatment options that is associated with significant morbidity and mortality. Non small cell cancer is the most common type of lung cancer (85%) encompassing 3 subtypes (adenocarcinoma, squamous cell, and large cell carcinoma) and prognosis depends on various factors, including the stage of the cancer, the type of treatment received, and the patient's overall health.

Automated insulin delivery systems, also known as artificial pancreas device systems, link a glucose monitor to an insulin infusion pump that automatically takes action (e.g., suspends or adjusts insulin infusion) based on the glucose monitor reading. These devices are proposed to improve glycemic control in patients with insulin-dependent diabetes, in particular, reduction of nocturnal hypoglycemia.

The hemophilias are a group of related bleeding disorders that most commonly are inherited. Inherited bleeding disorders include abnormalities of coagulation factors and platelet function; the most common of these disorders is von Willebrand disease. However, when the term "hemophilia" is used, it most often refers to the following two disorders: ●Factor VIII deficiency (hemophilia A) ●Factor IX deficiency (hemophilia B, also called Christmas disease) Patients with hemophilia, particularly those with severe disease, develop bleeding episodes that are treated with replacement of the missing factor (ie, factor VIII or factor IX concentrates). A complication of hemophilia treatment is the development of an inhibitor, which usually occurs shortly after replacement therapy has been initiated. The inhibitors are antibodies (primarily IgG) directed against the specific deficient factor. Development of inhibitors is typically assessed in relationship to the number of exposure days (ie, days on which the patient has received one or more doses of replacement factor). <a id="

Home cardiorespiratory monitors track respiratory effort and heart rate to detect episodes of apnea. They have been used for a variety of indications that may be associated with increased risk of respiratory compromise.

Transcutaneous electrical nerve stimulation and transcutaneous afferent patterned stimulation are noninvasive neuromodulation techniques that involve the application of electrical stimulation to the surface of the skin. In addition to more traditional settings such as a physician’s office or an outpatient clinic, these techniques can be self-administered in an individual's home.

Oscillatory devices are alternatives to the standard daily percussion and postural drainage method of airway clearance for individuals with cystic fibrosis. There are several types of devices including high-frequency chest compression with an inflatable vest and oscillating positive expiratory pressure devices, such as the Flutter and Acapella devices. Respiratory therapists and other providers may also use oscillatory devices for other respiratory conditions such as diffuse bronchiectasis, chronic obstructive pulmonary disease (COPD), and respiratory conditions associated with neuromuscular disorders.

Patients who are prescribed chronic warfarin anticoagulation need ongoing monitoring that has generally taken place in a physician’s office or anticoagulation clinic. Home prothrombin monitoring with a U.S. Food and Drug Administration (FDA)‒approved device is proposed as an alternative to office or laboratory-based testing.

Myoelectric prostheses are powered by electric motors with an external power source. The joint movement of an upper-limb prosthesis or orthosis (eg, hand, wrist, and/or elbow) is driven by microchip-processed electrical activity in the muscles of the remaining limb or limb stump.

Monochromatic infrared energy (MIRE™) is a therapy that uses pulsed infrared light at a wavelength of 880 nm through pads that contain an array of 60 superluminous infrared diodes. Use of MIRE™ has been proposed as a therapy for multiple conditions including cutaneous ulcers, diabetic neuropathy, and musculoskeletal and soft tissue injuries. The available literature regarding skin contact MIRE as a technique to treat various cutaneous conditions consists of small controlled trials and observational studies. MIRE has also been investigated for knee osteoarthritis. The current evidence from the studies with the strongest methodology, ie, sham-controlled trials with a between-group design, shows no improvement in outcomes for patients treated with MIRE. This evidence does not support the efficacy of this technology. Well-designed, prospective, randomized controlled trials with larger subject numbers are needed to determine with certainty whether MIRE is an effective treatment for cutaneous conditions. As a result, this technology is considered investigational.

Microprocessor-controlled prostheses use feedback from sensors to adjust joint movement on a real-time as-needed basis. Active joint control is intended to improve safety and function, particularly for patients who can maneuver on uneven terrain and with variable gait.

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Cranial orthoses involve an adjustable helmet or band that progressively molds the shape of the infant cranium by applying corrective forces to prominences while leaving room for growth in the adjacent flattened areas. A cranial orthotic device may be used to treat postsurgical synostosis or positional plagiocephaly in pediatric patients.

Continuous passive motion devices are used to keep a joint in motion without patient assistance. Continuous passive motion is being evaluated for treatment and postsurgical rehabilitation of the upper- and lower-limb joints and for a variety of musculoskeletal conditions.

The published data suggest that MI-E can improve the intermediate outcome of peak cough expiratory flow. Data regarding its role in the clinical management of the patient consist of case series. In some studies, patients have served as their own control, with a decreased incidence of hospitalization among patients who switch from tracheostomy to a noninvasive approach, which may include MI-E as one component. While controlled trials would ideally further delineate who is most likely to benefit from MI-E, particularly those who would benefit from having such a device in the home, such trials are logistically difficult. The heterogeneous nature of the patients, even among those with similar diseases, almost mandates a case by case approach for these patients. For example, the clinical utility of MI-E would not only depend on the physiologic parameters of lung function, but also on the tempo of the disease course, the availability of home caregivers, and patient preference and motivation. The non-investigational status for the MI-E device is based on these considerations. 2004 Update A search of the literature for the period of 2003 through July 2004 did not identify any published articles that would prompt reconsideration of the policy statement. Therefore, the policy statement is unchanged. <a id="

Meniere disease is an idiopathic disorder of the inner ear characterized by episodes of vertigo, fluctuating hearing loss, tinnitus, and ear pressure. Conservative therapy includes a low sodium diet and diuretics to reduce fluid accumulation (ie, hydrops) and pharmacologic therapy to reduce vestibular symptoms. Transtympanic pressure treatment has been proposed as an alternative treatment for Meniere disease. This treatment involves the use of a handheld device (eg, Meniett) that delivers air pressure pulses to the ear. For individuals who have Meniere disease who receive transtympanic micropressure therapy (Meniett), the evidence includes randomized controlled trials and systematic reviews. The relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Six randomized controlled trials of positive pressure therapy have been reported, with five specifically investigating the Meniett device. Systematic reviews of these five trials found that micropressure therapy does not result in a greater reduction in vertigo than placebo. The sixth trial also found no significant benefit of the transtympanic micropressure therapy for Meniere disease. The evidence is sufficient to determine that the technology is unlikely to improve the net health outcome.

An external infusion pump consists of a portable attachment that has been designed to administer an infusion therapy on an outpatient basis for an extended period. This device is usually the size of a portable tape player and can be use around the patient's waist or in the form of a shoulder strap. It can be used to administer medications by several routes i.e. intravenous, intraarterial, intraperitoneal, epidural, intrathecal and intraventricular. A heparinized saline solution is used between infusions to keep the catheter clean and ensure patency. This attachment is operated by batteries and the reservoir for medications does not allow its invasion. The medication is administered through a catheter. Chemotherapy for cancer in the home Advances in cancer treatment have made it possible for some forms of chemotherapy to be offered at home. This can be achieved under strict conditions where there is a specific protocol, availability of medical services and supervision of specialized nursing care, motivation, specialized training, adequate environment and home locationand the individual characteristics of each patient. The Agency for the Evaluation of Technologies and Modes of Intervention in Health (AETMIS) of Canada conducted between 2001 and 2004 a study on this topic focusing on treatment initiatives, continuity of treatment, access to high quality oncological services, quality of life, effectiveness, safety, preference and patient satisfaction and cost. <a id="

Low-intensity pulsed ultrasound (LIPUS) has been investigated as a technique to accelerate healing of fresh fractures, surgically treated closed fractures, delayed unions, nonunions, stress fractures, osteotomy sites, and distraction osteogenesis. Low-intensity pulsed ultrasound is administered using a transducer applied to the skin surface overlying the fracture site.

An external infusion pump (EIP) is a portable device intended to provide continuous ambulatory drug infusion therapy over an extended time period. The EIP is also known as an external pump, ambulatory pump, or a mini-infuser. The EIP is usually the size of a portable cassette player and can be worn on a belt around the patient’s waist or from a shoulder harness. It is a battery driven device. Proposed drug delivery routes using the EIP include the intravenous, intra-arterial, sub-cutaneous, intraperitoneal, epidural, intrathecal, and intraventricular routes. A heparinized saline solution may be used during an interruption of drug therapy to maintain catheter patency. The EIP is battery powered, and drug reservoir refilling is non-invasive. A catheter from the pump is attached to the desired access route for drug delivery. <a id="