Fitbit, Inc.

South Korean Woori IO, a developer of noninvasive continuous glucose monitors, believes new FDA rules regarding wearables will accelerate the company’s commercialization process. Woori, which was recently acquired by OSR Holdings, plans to launch first in the consumer wellness wearables category before expanding to the medical grade space. In January, FDA announced plans to limit regulation of wearable medical devices. The move has been celebrated by manufacturers in the space, who largely believe this will accelerate the market even more over the next 12 months. Currently, the majority of fitness tracking wearables and fitness apps are classified as non-medical devices, meaning they are already exempt from strict regulations. New FDA policy will add to this existing policy, taking an even more limited regulatory approach towards companies like Apple, Whoop, FitBit, and Oura. The majority of wearable medical devices do not make claims related to disease diagnosis or treatment, and tend to track metrics like sleep, calories burned, and daily stress. FDA Commissioner Marty Makary did clarify that if companies make a wearable device that claims to be “medical grade,” tracking markers like blood pressure, they will be more strictly regulated by the agency. Following this announcement, shares of CGM manufacturers Abbott, Medtronic, and Dexcom rose between 1% and 4%. Several major device companies have set their sights on the development of non-invasive CGM’s over the last several years, as the blood glucose monitoring devices market is expected to exceed $40 billion by 2030. This is predicted to be driven by noninvasive and wearable CGMs. Woori IO believes this new regulatory clarity will accelerate time-to-market for the company, which plans to first launch consumer-grade, lifestyle-management wearable solutions, while continuing its longer-term development roadmap toward medical-grade CGM systems. During phase one of its long-term strategy, Woori will release products and software features that are intended to provide noninvasive, glucose-related insights for lifestyle, nutrition, and activity management. Under new FDA regulations, Woori will be able to accelerate its go-to-market time for phase one, since such devices won’t be faced with scrutiny from regulatory agencies. The company plans to position these offerings as “general wellness tools” that are not intended for diagnose, treat, or sway clinical decision-making. During the second phase of its commercialization plan, Woori plans to launch devices that deliver clinically actionable glucose data for diabetes management, either via smartwatch-integrated systems or Woori IO's own standalone wearable platforms. Due to the clinically actionable nature, these devices will be subject to FDA scrutiny. The company believes that early integration as a consumer wellness feature provides a scalable entry point to market while longer-term medical validation proceeds. New FDA rules allow companies to decouple commercialization from longer medical-device approval timelines without compromising scientific rigor or future regulatory objectives. By launching first in the consumer wellness category, Woori plans to accelerate user adoption, generate real-world performance data, and deepen its existing partnerships, while maintaining a clear pathway toward regulated medical applications. "We view the FDA's clarification as a meaningful development," Sunkie Park, CEO of Woori IO, said in a prepared statement. "It supports responsible innovation by clearly distinguishing wellness insights from regulated medical claims, enabling faster market entry while we continue investing in clinical validation."

Just days ago,a  federal jury in the U.S. District Court for the Central District of California ruled that Apple must pay $634 million to Masimo for allegedly infringing on a patent covering ‌blood-oxygen reading technology. The case was just one in a long line of disputes between the two companies, and a long line of disputes between companies in the wearables market in general. Bill Betten, director of medtech solutions for S3 Connected Health, a digital health partner for pharma and medtech companies, connected with MD+DI to discuss what this ruling means for the wearable industry, big tech, and the future of wearables patents. How might this ruling influence other medtech companies' patent enforcement strategies against Big Tech? Betten: Patents are only as good as a company’s willingness to enforce them. However, it takes a lot of money to both maintain the portfolio and a lot more to pursue and act against a company. It obviously makes the news due to the size of the award and the names of the participants. It should be viewed as a cautionary tale, particularly for the bright start-ups that get enamored with their solution but may not have done sufficient patent work to understand the total intellectual property landscape. What does this victory mean for Masimo's competitive positioning in the wearables market going forward? What about for Apple's? Betten: It was actually a very narrow decision around a single patent. This patent basically describes a change in power management of a “patient monitor” (the choice of words is important) in response to a change in a physiological parameter, such as a threshold, event, or signal characteristics. Basically, the patient monitor can change operating states in reaction to one of these changes. Apparently, what was at issue was not the implementation of this feature in the Apple watches as Apple admitted that they had indeed done so. However, the conflict was over whether or not the watch was a “patient monitor,” thus violating the primary claim of Masimo’s patent. Since it was deemed to be a patient monitor, then the patent was violated. This is a narrow patent and violation. However, it does point out the importance of what features and functions are claimed for these devices. In many cases the discussion is around whether or not a consumer device is being positioned as a medical device, for which the FDA has a very definite definition. So, one must be careful in how they are positioning their device. This conflict was about patented features implemented in a “patient monitor.” Since the Apple watch was deemed to be a “patient monitor,” it was a violation of the patent according to the decision. How might this influence FDA's approach to regulating medical features in consumer devices? Betten: I’d prefer to think of it in a slightly different way. The FDA regulates medical devices and has for decades. They are very specific in noting that a medical device is “an instrument, apparatus, implement, machine, contrivance that is manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state.” While often criticized, the FDA has established regulations which address the development and validation of medical devices. That is one of the few product areas that if you claim your product does something (“intended use”), you generally must show that it works. So, it really isn’t a question of the FDA regulating consumer devices. It is really a question of when does a consumer device cross over into the medical device space, where it should be regulated.  Earlier this year, Whoop stepped across that line when their claims about blood pressure monitoring and its use crossed that line and the FDA called them on it. Is there anything else you would expand on? Betten: There is clearly a place for consumer-oriented devices that are not medical devices yet provide useful information to patients and doctors. The challenge is about understanding the limitations of such devices that have not been through the rigor associated with medical devices, including risk, safety, quality, and verification that the device does what it is supposed to do. Those devices may work well on the healthy, but as an old pulse oximeter device person myself, does that device work for all conditions, skin tones, motion states, etc. If not, and if not clearly stated so, it may well be that people relying on it will find out too late that it doesn’t work for them. Best case, it is harmless. Worst case, they may take actions based on incorrect information that could threaten their health. A Fitbit lawsuit in 2016 addressed that very issue.  So, the consumer can use the device, but should be aware of its limitations as well as its capabilities.

Apollo Hospitals, one of India's biggest hospital chains, has announced a new partnership to further develop its AI tool for predicting cardiovascular disease risks. It will collaborate with 3M spinoff Solventum Health Information Systems to use its patient classification and quality methodologies to enhance cardiovascular care. Specifically, Solventum's tools will be integrated with Apollo's AI-powered Cardiovascular Disease Risk technology. They will later work to assess the effectiveness of their combined solution on population health and resource efficiency metrics, including mortality, lengths of stay, complications, and readmissions. "The project aims to evaluate opportunities to deliver high quality care in the most cost-effective way by leveraging the potential of diagnosis related groups, case mix index, and the severity of illness, and by increasing the efficiencies in resource utilisation," their media release read. WHY IT MATTERS The partnership zeroes in on cardiovascular diseases, the leading causes of premature death and morbidity in India. Given its growing burden (cardiovascular diseases account for over a quarter of deaths in the country) alongside the continuing severe cardiologist shortage – now at one cardiologist per 250,00 people, the use of predictive analytics has become more critical to bridge this gap, they said. The enhancement of Apollo's predictive analytics tool is expected to boost Apollo's capability to identify patients at great risk of adverse outcomes and further hospitalisation. THE LARGER CONTEXT Apollo introduced its Cardiovascular Disease Risk tool in 2021. Built using data from more than 400,000 patients, the tool takes into account lifestyle attributes and vital signs to predict an individual's risk of cardiovascular diseases. The following year, the predictive tool was integrated into ConnectedLife , a healthcare application and a Fitbit partner in Singapore. Besides predictive analytics for cardiovascular care, the hospital chain has pursued various AI projects over the past years. Most recently, Apollo Hospitals has reportedly planned to adopt AI copilots from Microsoft as part of a new partnership to support its AI roadmap implementation. ON THE RECORD "This powerful union enables us to pinpoint high-risk patients more accurately and deliver timely, personalised care. This breakthrough is leading to a dramatic reduction in complications and hospital stays while fundamentally transforming patient outcomes and broadening access to the high-quality care every individual deserves," Apollo Hospitals co-managing director Dr Sangita Reddy said. "We believe this collaboration can help us more accurately identify patients who are at high risk of adverse outcomes that may need additional services. We anticipate improved patient access, operational efficiency, and clinical outcomes as a result of our joint efforts," added Dr Sandeep Wadhwa, global chief medical officer at Solventum HIS.