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Why the FDA Cleared MediPines’ Real-Time, Noninvasive Respiratory MedTech


One of the most promising things in health tech these days is the inventiveness that has consumed data gathering and analysis. It’s not just artificial intelligence and analytics or our long-awaited use of electronic health records data or even all of that wonderful wearable technology. Each of these steps forward in data analytics is encouraging, and when you put all the pieces together, the clinical potential is hard to ignore. What’s also impossible to overlook is just how far the medical device industry has come in its data collection efforts.

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Over on our sister site, Healthcare Analytics News™, we tend to focus on medical devices only when cybersecurity and data privacy are at stake. But for the past couple of years, we’ve pored over data analytics software, EHR use cases and everything else in health IT. So, I saw joining forces with MedTech Boston as a welcome chance to start examining how medical device makers were adapting to the digital transformation. This data-driven age. If consumers are getting unprecedented access to biosensors and electrocardiogram readers, surely medical device manufacturers are upping their data collection game. And many of them are. So, when the occasion arises, I plan to highlight these med-tech data advances. How do they differ from traditional methods, and how might the contrast affect outcomes? What does it mean for medicine?

Here’s the latest example of an innovative medical device that took an old concept and turned it on its head. Today MediPines broke the news that its Gas Exchange Monitor received 510(k) market clearance from the U.S. Food and Drug Administration. It was an unsurprising next step for a breakthrough respiratory device whose makers say is all about real-time data for critical real-world decisions.

So, what makes the MediPines Gas Exchange Monitor interesting?

Simply put, it’s new. The Gas Exchange Monitor is the first medical device to integrate a “comprehensive set” of respiratory parameters and indicators drawn from a patient’s breath in a noninvasive test. What’s key is the word “noninvasive.” Until now, clinicians have been confined to invasive or seriously complicated methods to make treatment calls for respiratory conditions.

But through a test that takes minutes, this technology analyzes respiratory rate, oxygen saturation, pulse rate, respiratory quotient and end-tidal carbon dioxide and then delivers information on indices like oxygen deficiency. That is, no doubt, novel.

“This is a result of years of scientific and medical research working with the world-renowned respiratory physiology team led by Dr. John B. West,” noted MediPines CEO Steve Lee. (So far, the company has published four papers on the technology behind the medical device.)

The hope is that the Gas Exchange Monitor can provide insights into pulmonary gas exchange at the point of care to fuel game-time decisions, whether they be diagnoses, treatments or triage. And that stream of easy-to-access data seems like good news for the 33 million U.S. patients who have respiratory diseases.

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