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Parallax preps for 510(K) clearance for its Fotodigm-powered remote patient monitoring platform

The move sets Fotodigm up nicely to get an alphanumeric CPT code vital for billing medical services

Parallax Health Sciences is an outcomes-driven telehealth company that focuses on cost-effective remote diagnosis, treatment and monitoring of patients with chronic diseases

Parallax Health Sciences Inc (OTCMKTS:PRLX) announced Thursday that it is preparing a 510(K) application to be filed with the US Food and Drug Administration for its Fotodigm-powered remote patient monitoring platform.

The Santa Monica, California, company recently announced that its wholly owned subsidiary Parallax Health Management Inc launched Fotodigm-powered mobile apps as part of its patented remote patient care and telehealth technology platform. 

READ: Parallax Health Sciences seeks to expand remote patient-monitoring platform

“The rapid growth of mobile health apps has resulted in confusion among health care providers and the public about which products rely on evidence-based medicine,” said Dr David Stark, chief regulatory officer at Parallax Health Sciences. “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.”

Eyeing a CPT code 

The company is eyeing a Current Procedural Terminology, or CPT code, which is a listing of alphanumeric codes medical coders use to report medical, surgical, and diagnostic procedures and services to physicians and health insurance companies.

“Alongside the development of a trusted technology, is the ability for Fotodigm to obtain CPT codes ... which will allow for a substantial broadening of the medical community for billing for services,” said Parallax Health Sciences CEO Paul Arena.  

The company offers a proprietary platform called Parallax Care under which the vital signs of patients afflicted with asthma, heart disease, diabetes, autism or an addiction can be monitored to check adhearance to their medical and drug regimens.

Parallax’s platform also can help doctors determine ways to improve patients’ conditions and accomplish those goals while reducing costs for both parties.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter@UttaraProactive 


Quick facts: Parallax Health Sciences

Price: 0.11 USD

Market Cap: $22.09 m

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