Diagnostic imaging startup company Caption Health and health tech mogul Philips stated that the FDA cleared them for ultrasound tools that could help healthcare professionals with imaging for coronavirus patients. On May 13, 2020, Philips stated that they received 510(k) clearance to market a variety of existing ultrasound products that are intended to treat patients with cardiac complications and coronavirus-related lung problems. Caption Health is a startup company that gained De Novo authorization in February for its first tool to help non-specialists take quality cardiac ultrasounds. The company stated on May 12 that the FDA approved them for a software update ahead of schedule to help provide more extensive guidance to the healthcare industry specializing in ultrasounds.
These clearances are in addition to the ones that healthcare system Atrium Health deployed to mobile startup company Butterfly Network, which is responsible for creating a point-of-care ultrasound device for high-priority sites, such as COVID-19 units. The Butterfly iQ is a portable ultrasound device that can be used well beyond the scope of the pandemic due to its ability to provide doctors with data they need quickly to access a patient's lungs and hearts. The equipment is also quickly cleaned when compared to larger scanning machines and can be used to treat more patients. When coupled with the new protocols instituted by Philips, the health care world can expect to see great changes to medical practices with regards to treating patients who are infected with COVID-19.
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Cardiac complications have been a consistent complication of the coronavirus since patients first become hospitalized in Wuhan, China. It has been a notable risk factor among those who have died from COVID-19 complications. Hospitals and healthcare systems are short-staffed and suffering financially due to the rising costs of the pandemic. Because of this, it has been challenging to quickly and effectively identify and address norovirus with cardiac complications before the virus becomes untreatable and causes death.
The FDA has attempted to address these issues by making access to relevant tools more prominent. In mid-May, the FDA awarded emergency use authorization to a cardiac dysfunction detection system created by Eko. The next day, the FDA cleared a software system that helps teach users how to use devices that capture ultrasound images. It took 25 dates to review the procedure and give approval.
These approvals are in an attempt to help manage the coronavirus and provide healthcare workers without specialized echocardiography training the information needed to operate machines that capture heart images. The FDA hopes that these software approvals reduce the need for sonographers to capture images among COVID patients, which would reduce the number of healthcare workers that are directly exposed to the virus.
The news of the FDA clearances were reported alongside details of the expansion of an existing ultrasound machine created by Butterfly. The devices are currently being used by Atrium Health, which is a healthcare organization that contains more than 40 hospitals. The Butterfly iQ portable whole-body ultrasound device is currently in operation at more than 30 locations, including emergency departments, intensive care units, and COVID-19 centers. Like other portable ultrasound devices, Butterfly is using its technology to manage COVID patients and monitor the condition of their heart and lungs.
Philips Posts Guide To Help Healthcare Professionals Treating Lung Infections
Healthcare giant Philips posted about their 510(k) clearance for a wide range of ultrasound products and software that can specifically be used for imaging in COVID-19 patients. The company posted its guidance to healthcare workers along with its clearance, which involves using a handheld scanner and mobile app as devices that are among particular importance in the fight against COVID-19.
The document contains instructions and information necessary for healthcare professionals who are currently treating and managing patients with COVID-19, including information on how to manage lung infections, COVID-related pneumonia, and other cardiac complications. The guide provides information on how to use Philips ultrasound machines, such as Sparq, CX50, Lumify, Affanti series, and EPIQseries ultrasound systems. It also provides information for off-cart salutations such as QLAB advanced quantification software.
According to the guide, lung ultrasound imaging can be used in the following COVID-19 related situations:
Ultrasounds Are Necessary To Evaluate COVID-19 Patients
The Pillips guide indicated that COVID-19 patients are at an increased risk of developing cardiac complications and lung dysfunction. Respiratory strain can also cause cardiac problems. A cardiac ultrasound exam helps evaluate the effects of COVID-19 and its progression in regards to a patient’s heart function. The guide also stated that it’s important to procure a set of procedures that minimizes the healthcare staff’s risk of catching the virus. This includes rapidly acquiring views necessary to assess cardiac health and measuring and assessing cardiac function off cart.
Cardiac complications among COVID-19 patients affect both the left and right functions of the heart. Therefore, there needs to be a set of standards in place to use echocardiography in a timely manner to assess heart functions, including its volume capacity. Providing these estimates can be a matter of life or death for some COVID patients with underlying health conditions. ASE recommendations state that to monitor the disease progression of patients with COVID, it’s best to use bedside echocardiography to evaluate right and left heart function, pericardial effusion, and cardiac hemodynamics.
Exam protocols call for limiting the risk of infections for healthcare providers while evaluating patients with COVID-19. This includes reducing the scanning time while using echocardiography and ensuring that accurate information is obtained by using custom exam protocols. The protocols must provide reduced operator interaction with the machine, automatic switch modes, and user specific image acquisition sequencing.
New Ultrasound Devices Can Be Used Beyond The Pandemic
According to executive vice president and chief transformation and strategy officer at Atrium Health Dr. Rasu Shrestha, the Butterfly iQ device is just as critical to the medical professional as the mental image of a doctor with a stethoscope around their neck. Dr. Shrestha stated that the device has already given Atrium Health greater abilities to monitor and screen COVID-19 patients by providing a clear and immediate picture of what’s happening in their lungs. Dr. Shrestha stated that Atrium Health will continue to see the benefit of the device well beyond the pandemic as it is being used to provide care for heart patients.
Atrium is the first major health system in the United States to use the point-of-care ultrasound device. The device allows a doctor to safely and quickly examine various areas of the patient’s body and can be used during an office or home visit. The device also helps doctors with common procedures, such as putting in central lines and vascular access. It does not subject the patient to radiation like an X-ray or CT scan, and it reduces the risk of infection of the hospital staff. The device runs on a software platform that is designed to make ultrasound work simpler. It works directly within existing systems that can be operated bedside and stays secure with security tools that are linked to the cloud. Its small size allows healthcare providers to clean the device quickly and move between patients, which is not possible with larger imaging devices.
According to Dr. John Martin, chief medical officer at Butterfly, point-of-care ultrasound plays an important role in helping healthcare systems deal with the pandemic. He stated that healthcare providers have seen it used to assess cardiac and lung involvement as well as to monitor the progression of disease in patients in urgent care centers, self-isolating at home, or even in Atrium’s virtual COVID unit. Dr. Martin stated that the value of the Butterfly iQ extends beyond the pandemic. It has the ability to provide doctors with important tools they need to help patients and streamline workflow, which may change the medical imaging process forever.