The Lymphedema Market is segmented by therapy, by compressiontechnology, and by products type . It has presence of many players in the Lymphedema market report. The market is consolidated with many devices owing to rising chronic diseases such as diabetes, cancer and other diseases.
The Lymphedema market insights is expected to be driven by the factors such as technological advancement in Lymphoedema, and rising demand for efficient and safe self administration drug delivery system. However, the strict regulation in the use of plastics for syringe production and product recalls due to manufacturing error are likely to restraint the market growth.
Lymphoedema can be treated with usage of compression therapywhich mainly includes pumps, garments, and others. The compression devices orpumps work on intermittent pressure technology and belongs to Class II devices. The sponsor must implement a Quality Management System (QMS) that meets FDA Quality System Regulation (QSR).
It requires to conform to the performance specifications of the clinical parameters used by the predicate devices in frequency, wavelength, time, and power output. Manufacturer must prepare and submit a 510(k) Premarket Notification application and pay required fee. FDA issues 510(k) clearance letter which is posted online.
The present reimbursement scenario in the United Statesincludes a mix of public and private third-party coverage and employers,individuals, and the government all contribute to the costs related to healthcare.
The individual and employers pay premiums to private insurance companies to cover healthcare costs. The government provides coverage at two-level- federal level (Medicare, Department of Defence, Bureau of Indian Affairs) and state level (Medicaid) to specific populations.
The government usually protects the sub-populations typically include the elderly (65 and older), low-income, disabled, and veterans, among others. Private insurers may also provide care coverage to citizens that receive government insurance (Medicare/Medicaid).
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