Parallax Health Sciences, a US-based an integrated digital healthcare company, has announced its plans to file an application with the US Food and Drug Administration (FDA) for 510(K) clearance for its Fotodigm platform.
Parallax said that currently FDA regulates only small subsets of mHealth apps and drug administration, and is expecting FDA 510(K) clearance for its Fotodigm enabled remote patient monitoring platform.
In addition, its Fotodigm platform is also is expected to be issued a The Current Procedural Terminology (CPT) code for medical billing.
CPT code set is developed by the American Medical Association (AMA) through the CPT Editorial Panel to maintain uniform information about medical services and procedures for administrative, financial, and analytical purposes.
Parallax Health Sciences chief executive officer Paul Arena said: “Alongside the development of a trusted technology, is the ability for Fotodigm to obtain Current Procedural Terminology (CPT) codes. The CPT codes will allow for a substantial broadening of the medical community for billing for services.
“One of the huge problems of chronic disease management, an $800 billion sector in 2017, has been the ability to generate revenue through medical reimbursement. This is an area of focus for Parallax Care since we can reach a larger audience and achieve our mission of reducing costs, expanding access, and improving outcomes of healthcare.”
Parallax said that medical device manufacturers are required to register under section 510(K) of the Food, Drug and Cosmetic Act, to notify FDA about their plans to market a medical device at least 90 days in advance, known as premarket notification (PMN) or 510(K).
The PMN is expected to allow FDA to evaluate whether the device is equivalent to a device existing or identified as new device.
In April 2018, Parallax Health Sciences announced that its wholly-owned subsidiary, Parallax Health Management had launched Fotodigm powered mobile applications as part of its Good Health Outcomes Platform.
According to the company, Fotodigm has been developed on architecture that captures data that is processed and presented to Parallax’s behavioral augmented intelligence engine, known as the Intrinsic Code.
Parallax Health Sciences chief regulatory officer David Stark said: “The rapid growth of mobile health (mHealth) apps has resulted in confusion amongst health care providers and the public about which products rely on evidence-based medicine. Obtaining a 510(K) clearance with the FDA is a strong step forward toward differentiating our Fotodigm technology while developing trust in the marketplace that it has been reviewed and cleared by the FDA.”
“With the newly authorized CPT Codes that went into effect in January 2019, the medical community and regulatory agencies have begun the incorporation of digital technologies into mainstream use. This impacts the access to care for patients and dramatically impacts the potential revenue capacity of new medical technologies, especially those targeting the management of Chronic Disease.”