TEL AVIV, Israel – A home-based, smartphone-enabled urinalysis kit from Healthy.io has received clearance from the U.S. Food and Drug Administration. The Dip.io kit, the first product in the company’s digital health product portfolio, enables patients to conduct clinical grade urine tests at home. The FDA approval marks the first time the agency has cleared a device based solely on existing smartphone cameras for Class II clinical claims. “We are in the midst of the biggest economic value transition in history,” said Yonatan Adiri, founder and CEO of Healthy.io, in a statement. “Healthy.io is proud to have its pioneering technology withstand the rigor of FDA Class II trials and continues to pursue its mission of ushering in the era of the ‘medical selfie’ as it transforms embedded smartphone cameras into clinical-grade medical scanners.” The company is currently expanding its “medical selfie” portfolio to standardized assessment of chronic wounds.
FDA grants clearance to Hailie inhaler sensor
SAN MATEO, Calif. – The U.S. Food and Drug Administration has granted clearance for over-the-counter sales of Adherium’s Hailie sensor for use with ProAir HFA, Ventolin HFA and Flovent HFA asthma inhalers. The Hailie sensor, previously known as Smartinhaler, is a device that attaches to a patient’s asthma or chronic obstructive pulmonary disease medication inhaler to monitor and promote adherence as part of a self-management plan. “This latest clearance kicks off our official entry into the U.S. consumer market, giving the tens of millions of U.S. patients suffering from chronic respiratory conditions their own sidekick for asthma and COPD,” said Arik Anderson, CEO of Adherium, in a statement. The company’s Hailie solution tracks medication use and reminds the user with helpful nudges when it’s time to take doses. It also provides access to usage history to better understand patterns in the patient’s asthma and COPD. Adherium is also launching an online portal for health care professionals and clinicians that uses Bluetooth technology to provide patient-group data collection and reporting from Hailie sensors.
Industry welcomes FDA efforts to regulate mobile medical app development
WASHINGTON – Home health technology industry leaders believe the U.S. Food and Drug Administration’s proposed regulation around mobile medical apps is a step in the right direction.
“With the significant increase in the adoption of mobile health care apps, it is necessary to have regulated guidelines and the oversight to ensure the safety and effectiveness of medical devices—including mobile medical apps,” said Leena Palav, senior vice president and chief compliance officer at AMC Health, a provider of remote monitoring solutions. “But in order for these regulations to have the greatest impact, we need to ensure that the digital health guidelines are not released in isolation because this can be confusing to the industry.”
Dr. Scott Gottlieb, FDA Commissioner, said in a viewpoint published this month in JAMA that regulation can encourage development and utilization of mobile medical apps. He said that the health care industry has historically been slow to implement disruptive technology tools, in part because of uncertainty surrounding regulation.
To address the issue, the agency released a Digital Innovation Plan last year, which included plans for a pilot program that would allow makers of low-risk software-based medical devices to self-certify their products and avoid the traditional premarket review process. Nine companies including Apple, Fitbit and Johnson & Johnson were selected to participate in the pilot, which is expected to start next year.
The FDA also announced plans to not regulate mobile apps intended to maintain or encourage healthy living.
“For the sake of patient safety, we believe any digital solution used to diagnose and/or treat a medical condition should be held to a regulatory standard,” said Larissa D’Andrea, senior director of government affairs at sleep solutions provider ResMed. “If done right, such regulation will instill greater patient and provider confidence in connected health solutions and encourage their adoption.”
FDA advances ‘more modern framework’ for prescription drugs that leverages digital health
WASHINGTON – The U.S. Food and Drug Administration says it’s willing to increase over-the-counter access to some medications to treat common and chronic conditions, if there are resources in place, like digital health technologies, to determine if the treatment is appropriate.
In a statement, Dr. Scott Gottlieb, FDA Commissioner, said the FDA’s approaches could include applying digital health technologies like mobile apps that would support consumers in appropriately and safely self-selecting and using certain drugs.
“While the FDA doesn’t have a direct role in the cost of medicines, we’re very mindful of the time and financial cost to patients and the health care system to fill a prescription medicine—particularly one taken repeatedly for chronic conditions,” he said. “Our hope is that the steps we’re taking to advance this new, more modern framework will contribute to lower costs for our health care system overall and provide greater efficiency and empowerment for consumers by increasing the availability of certain products that would otherwise be available only by prescription.”
The agency has drafted guidance that lays out a process whereby a sponsor—for example, a company that has a prescription drug—could develop a mobile app that increases the likelihood of correct self-selection and accurate use of the product in the nonprescription setting. After demonstrating through studies that consumers can safely use the drug without a prescription and with associated supervision of a health care professional, the sponsor could submit an application for FDA consideration for nonprescription status for the product.
“As we move into making this a reality, the FDA will ensure that products considered under this framework receive a robust scientific review to ensure they can be used safely by patients,” Gottlieb said. “Our ultimate goal with modernizing our regulatory framework for nonprescription drugs is to help facilitate a market that is more competitive, enables greater access to medical products, empowers consumers in their health care decisions, and provides more affordable options for Americans.”
FDA clears wearable wound suction drain device
MEMPHIS, Tenn. – The U.S. Food and Drug Administration has granted clearance tothe SOMAVAC 100 Sustained Vacuum System, a wearable closed suction drain device that applies sustained vacuum to a closed wound following surgery to remove fluid effectively and reduce the risk of seroma. “This FDA clearance represents a critical milestone for SOMAVAC and provides a meaningful advancement in post-surgical care, offering patients the opportunity to recover with dignity at home after major surgeries,” said Esra Roan, CEO of SOMAVAC Medical Solutions, in a statement. The SOMAVAC 100 was designed to replace the legacy technology of using suction bulbs with surgical drains.
MiniMed diabetes management system approved for pediatric use
DUBLIN – The U.S. Food and Drug Administration has expanded approval of Medtronic’s MiniMed 670G system for patients with Type 1 diabetes age seven and older. The system was previously approved for those age 14 and older. “We are thrilled to be able to offer this advanced insulin management system to younger patients and their caregivers to help alleviate some of the burden associated with this unrelenting disease and to improve their quality of life,” said Dr. Francine Kaufman, chief medical officer and vice president of global regulatory, medical and clinical affairs of the Diabetes Group at Medtronic, in a statement. “This expanded age indication provides an important new treatment option for pediatric clinicians and parents of young children with Type 1 diabetes, and further demonstrates our strong commitment to improving outcomes across the full diabetes care continuum.” The MiniMed system features the company’s SmartGuard technology and Guardian Sensor 3 continuous glucose monitoring, which work together to automate the delivery of a personalized amount of basal insulin every five minutes based on sensor glucose values. The system constantly self-adjusts to help avoid highs and lows.
Adherium takes smartinhaler over the counter
‘This opens up channels for patients to get their arms around their disease’
SAN MATEO, Calif. – Adherium recently received clearance from the U.S. Food and Drug Administration to market its smartinhaler sensor technology direct to consumers, paving the way for people with respiratory conditions to purchase the device over the counter, without a prescription.
“This is part of our overall strategy in the U.S.,” said Arik Anderson, CEO of Adherium, which plans to launch the technology here by the end of June.
Adherium’s smartinhaler sensor was developed for use with AstraZeneca’s Symbicort aerosol asthma inhaler. It is installed into a patient’s inhaler to monitor and promote asthma and chronic obstructive pulmonary disease medication as part of a self-management plan, Anderson said.
The smartinhaler sensor records the date and precise time the inhaler is used and automatically transmits that data to an app on the patient’s phone or tablet. It also stores historical data on usage patterns, allowing physicians to review and help make evidence-based decisions.
“Adherence is not just about remembering to take your medication, but also to ensure you’re using it correctly,” said Anderson. “If the physician is not seeing positive results, they can use the data collected by the smartinhaler to dig deeper and see what’s actually going on. For the first time, this device provides the physician with the feedback that goes beyond patient recollection.”
The sensor design also includes three buttons that help patients access the audio/visual reminders, battery monitoring and Bluetooth wireless technology.
Anderson said several clinical studies over the past couple of years have shown that the use of the company’s smartinhaler technology can decrease visits to the emergency room and missed school days by young patients with asthma and COPD.
“They are good statistics, but if you don’t have access to the technology it can be frustrating,” he said.
Direct-to-consumer approval is a key step in Adherium’s journey through the health care system, said Anderson.
“This FDA approval begins to open up channels for patients to get their arms around their disease,” Anderson said. “It’s the beginning of being able to address the $34 billion problem of non-adherence to respiratory medication.”
FDA shifts focus as digital health evolves
BOSTON – Bakul Patel said his agency could become known as the ‘U.S. Food, Device and Drug Administration’ in the future as the digitization of health care continues to evolve.
“Digitization is happening all around us—especially in health care,” said Patel, associate director for digital health, U.S. Food and Drug Administration, to attendees of the Biomarkers & Immuno-Oncology World Congress this week. “We are seeing health care move from the clinic to the patient.”
That shift is driving the work of the FDA, as the agency moves to a more pragmatic approach and focuses on higher-risk functionality of medical devices, assuring patient safety while encouraging advances in innovative technology and product life cycle, he said. Focus areas include software, sensors, technology and connectivity.
The rapidly evolving nature of digital health is sparking a paradigm shift, Patel said. The current regulatory premarket timeline is best suited for hardware-based products, but is making way for software development timelines, practices and rapid iterations.
Deterministic risks are shifting to evolving issues like cybersecurity, and a stable program volume of about 2,200 pre-submissions annually to the agency is expanding to the potential for an exponential increase in the volume of submissions.
These changes led the FDA to develop its Pre-Cert for Software as a Medical Device Pilot, which will review a digital health technology company’s systems for software design, validation and maintenance, and if it meets the necessary quality standards, pre-certify it. Pre-certified companies may be able to submit less information to the FDA than is currently required before marketing a new digital health tool.
“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” Patel said. “This program will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product.”
Digital health regulation welcome, experts say
BOSTON – Health experts are applauding the U.S. Food and Drug Administration’s work to regulate digital health and view new guidelines as ways to advance innovation and improve health care.
“There is a huge opportunity here,” said Dr. Fatima Paruk, chief medical officer, analytics, of Allscripts, at the Bridge to Pop Health conference in Boston this week. “We finally have a framework that outlines a way to get a lot of this technology developed at scale.”
Under the 21st Century Cures Act, some technology—including certain software that supports administrative functions, encourages a healthy lifestyle, serves as electronic patient records, assists in displaying or storing data, or provides limited clinical decision support—is no longer considered to be a medical device, nor regulated as such.
Building on the Cures Act, the FDA’s Digital Health Innovation Plan reimagines its approach to digital health medical devices with pragmatic approaches to advance the development of high-quality, safe and effective devices, while assuring timely patient access.
“We’ve historically been careful about what we deliver to a patient because of past regulations,” said Dr. Gowtham Roa, chief medical informatics officer, Blue Cross Blue Shield of South Carolina, at the conference. “The FDA’s work will only help facilitate progress in this space. “
The FDA also recently introduced the Medical Device Safety Action Plan, which outlines how the FDA can continue to enhance its programs and processes, while assuring the safety of medical devices.
“Our aim is to make sure that the new advances in technology that are enabling better capabilities and benefits are also harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs,” said Dr. Scott Gottlieb, FDA Commissioner, in a statement.
Experts applaud FDA’s plans to expand precertification pilot
WASHINGTON – The U.S. Food and Drug Administration’s Center for Devices and Radiological Health recently announced it was expanding its medical software precertification program and establishing an incubator for digital health technology.
Experts are applauding the agency’s efforts to continue advancing innovation in health care.
“The government’s commitment is clear,” said Linda Pissott Reig, a shareholder at Buchanan Ingersoll and Rooney, a law firm whose clients include home care and hospice services, post-acute care facilities and medical device companies. “The FDA has undertaken many new initiatives that signal a proactive and thoughtful approach to spurring new medical devices and medical technologies.”
The FDA said it is expanding its precertification pilot program, drafted last year to enable a more streamlined review of their software as a medical device, to include: tools that have multiple functions; artificial intelligence-based tools; and digital therapeutic tools.
Nine companies were selected last year to take part in the pilot: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily. The FDA hopes to add more companies and formally launch the expanded pilot by the end of the year.
“This regulatory attempt has the goal of moving the set point in the continuum of no regulation and extreme control toward a rational compromise between risk and cost and the speed of market availability,” said Dr. Joseph Roberson, chief medical officer of digital health platform provider VitalConnect. “A large number of differing medical technologies have brought about entirely new categories of devices and opportunities for device failure that has greatly complicated the FDA’s mission in recent years. I expect that trend will continue to accelerate.”
The agency also launched the Information Exchange and Data Transformation (INFORMED) incubator that will explore the use of real world data, biosensors, artificial intelligence and the Internet of Things to improve cancer treatment and drug development.
