Mobile healthcare, telemedicine, telehealth, BYOD

Remote Monitoring News

Remote Patient Monitoring Technologies Addressed by FDA

By Vera Gruessner

- The remote patient monitoring market is continually advancing throughout the healthcare industry with new products and technologies impacting the market on a constant basis. For example, the Food and Drug Administration (FDA) recently confirmed that the company Sentrian’s remote patient monitoring solution could be defined as a medical device, which would give the FDA the right for ‘enforcement discretion,’ according to a press release from Sentrian.

Remote Patient Monitoring Solutions

This also will allow the company to begin marketing its remote patient monitoring solutions broadly in the market. In February of this year, the FDA released a report about mobile medical applications, which stated the agency would develop a customized approach to regulating the mobile health app market as well as the mHealth devices segment of the digital medical technology.

Among the many mobile apps and devices that the FDA does consider under the definition of a medical device but does not pose any serious danger to patients and consumers, the federal agency will not pose excess enforcement nor administrative burden. For example, the FDA will not be requiring developers and manufacturers to submit applications or register their products if the technologies pose no harm to the users.

“We are encouraged by the FDA's well-balanced approach to nurturing innovation in mHealth while ensuring patient safety in their assessment process,” Dean Sawyer, Co-Founder and CEO of Sentrian, said in the company press release. “The FDA’s decision enhances our ability to provide value to patients and care providers managing chronic conditions such as heart disease, complex diabetes, and COPD by increasing our product development speed and agility. It also affirms Sentrian's mission to improve the quality of life for the patients we serve.”

A variety of healthcare organizations have already begun utilizing remote patient monitoring systems including cloud-based technologies to better track chronic medical conditions among their patient base. These remote patient monitoring tools, if properly integrated into a medical facility and interoperable or connected among a variety of necessary medical devices, could lead to the reduction of medical errors and the drop in the rates of hospitalizations throughout the healthcare industry.

“This is a landmark for Sentrian and the industry allowing unprecedented speed to continually deliver what patients and providers need,” Dr. Jack Kreindler, Sentrian's Founder and Chief Medical Officer, said in a public statement. “Internally we continue to build our technology to exceed the quality, security, privacy and safety management standards required for tightly regulated medical devices. This gives our clients and patients the added confidence they demand and prepares us for the near future when algorithmic decision support will steer personalized interventions, in advance of traditional evidence determining what's best for our patients.”

Another remote patient monitoring solution that’s made an impact is Authentidate’s telemedicine service, which has helped monitor the health of dialysis patients with kidney failure, according to a press release from Renal Ventures Management, LLC.

With all of these advancements, the global remote patient monitoring market is clearly growing and expanding among a variety of segments of the healthcare industry. A report from Kalorama Information called Advanced Remote Patient Monitoring Systems shows that the market is currently worth $31.4 billion. Telemedicine tools, wireless communication systems, portable monitors, and cloud-based patient portals that provide access to health records are all up-and-coming technologies that are revolutionizing remote patient monitoring and the medical care industry.

“Cost savings are the major driver of sales, but the demand to integrate data into an EMR has also helped fuel purchases of new PM systems,” Bruce Carlson, Publisher of Kalorama Information, said in a public statement. “There is also an increasing trend to upgrade to ambulatory and hand-held devices.”


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