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Q&A: Clarius on Its PAL HD3 Wireless Dual-Array AI-assisted Ultrasound

Q&A: Clarius on Its PAL HD3 Wireless Dual-Array AI-assisted Ultrasound
PAL HD3 Wireless Dual-Array AI-assisted Ultrasound. Courtesy of Clarius.

Clarius Mobile Health’s new PAL HD3 is a compact, wireless dual-array handheld ultrasound scanner that enhances diagnostic capabilities with exceptional image resolution, transforming patient care worldwide.

Clarius Mobile Health‘s PAL HD3 is a wireless dual-array handheld ultrasound scanner revolutionizing healthcare diagnostics. Unveiled at ACEP23 in October 2023, it merges phased and linear arrays for superior imaging. Delivering high resolution up to 40 cm deep, its portable, wireless design is compatible with iOS and Android, enhancing diagnostic accuracy on the go. Based in Vancouver, Clarius has been democratizing ultrasound technology globally since 2014. The PAL HD3, featuring FDA clearance, CE Mark certification, AI-assisted imaging, and advanced 8-beamformer processing, exemplifies their innovation.

With over 5 million scans in 90+ countries, Clarius CEO Ohad Arazi discusses its impact.

Ohad Arazi: Clarius is a Vancouver-based scale-up company. We were founded in 2014 with a mission to envision a future where better care is enabled by medical imaging in every setting. This includes providing access to nurses in the developing world, EMTs in an ambulance, family doctors in rural communities, surgeons in the hospital, or specialists in their clinics. We do that with this amazing innovation that I’m holding here in my hands.

Ohad Arazi: It’s the size of an iPhone. It’s fully wireless and, yet, it’s a full-fledged ultrasound system. It has a quality output comparable to some of the legacy systems you may have seen at the hospital. Now, you can appreciate how different it is from those big old carts with all their cables and knobs and buttons.

Some of the other companies in the hand-held ultrasound space have aimed for a similar form factor but they tried to create a Swiss army knife by having a single probe that does it all. To mimic the image quality comparable to what we’re getting from the mid-size, laptop-based systems in the hospital, we have to dedicate the form factor and the image resolution to the specialty area.

Ohad Arazi: When we thought about the phased array linear, we envisioned creating a specialty tool for primary care and internal medicine. This tool is designed for those analyzing areas from the neck to the abdomen. Recognizing the discrete needs for imaging this space, we noted that the organs in these regions vary in depth. Some are quite superficial, like the carotid, while others require deeper penetration, such as in cardiac or obstetric imaging. Additionally, larger organs need a bigger field of view.

We acknowledged that using specialty probes for such diverse anatomy would be challenging. This understanding guided our product management team and engineers in designing the PAL.

Ohad Arazi: To address a diverse set of use cases, we needed a highly versatile probe, the most diverse in the industry. We decided to create a dual array probe. Ultrasound works by using a technology called piezoelectric in a part of the probe called the transducer, which makes contact with the skin and produces images. 

For instance, a single array probe like this linear one has a narrow form factor, suitable for orthopedic surgeons needing a narrow footprint but a wide mouth to visualize large anatomy like the rotator cuff. However, we recognized the need for both superficial high-resolution imaging and deeper penetration for areas like the heart and abdomen. 

The challenge was to blend these capabilities into one probe. While some legacy handheld technologies had two transducers—one on each end—creating a two-in-one probe, this caused ergonomic challenges and limited imaging elements. 

In January 2023, the team conceived the idea of a dual probe sharing both sides, a linear and a phased array for deeper penetration. This led to the design concept of having two arrays on the same side and using software and AI to automatically toggle between views based on the anatomy being examined.

Ohad Arazi: The first function is to auto-detect the anatomy and then load the appropriate presets accordingly. This feature is vividly exemplified in the phased array linear probe. For instance, when transitioning from imaging the heart, where deeper penetration and a broader field of view are necessary for a comprehensive four-chamber apical view, the AI detects the focus on the heart and switches to the appropriate preset. 

Subsequently, as one moves from the heart to, for example, the carotid, the AI automatically adjusts to a shallower view, providing a deeper field of view for enhanced visualization of the anatomy. 

This process can be likened to how portrait mode functions on smartphones, where the AI recognizes facial features and selects the optimal settings for portrait photography, streamlining the user experience. Similarly, our AI presets detect the region being imaged and load the corresponding preset from a selection of over 70 options, including specific presets for various anatomical features in the face, chest, and abdomen.

Ohad Arazi: This probe covers a range from one to 15 megahertz. In ultrasound, lower frequencies provide deeper penetration, while higher frequencies offer higher resolution for shallower imaging. It can reach up to 50 megahertz, necessary for ocular imaging in cases like eye trauma.

Conversely, it can go as low as one megahertz for deep penetration, beneficial for pregnant patients or for imaging large limbs. With a penetration depth of up to 40 centimeters, it offers a broad range, from the surface to deep tissues. 

This versatility proves invaluable in rural communities, where studies have demonstrated that improved diagnostic certainty with our probe significantly reduces hospitalizations and patient travel. This reduction in costs and time is beneficial across healthcare systems, enhancing efficiency and accelerating diagnoses.

Ohad Arazi: The legacy referral cycle for ultrasound is often considered broken. In many cases, patients are referred by their family doctor to radiology due to a lack of onsite tools for diagnosis. This contributes to significant backlogs in radiology departments, resulting in delays of weeks or even months for imaging and report delivery.

Traditionally, ultrasound has been treated as a shared asset based on referral patterns, but the PAL disrupts this model by becoming a personal device for practitioners. It’s akin to having a stethoscope in their pocket, allowing for immediate access to diagnostic capabilities.

Physicians’ relationship with their Clarius device is notably different from that with larger ultrasound machines. This personal connection is evident in the numerous unboxing videos posted by physicians upon receiving their Clarius devices. This shift towards personalization empowers practitioners to make more informed decisions, maintain continuity of care, and feel more fulfilled in their practice.

Ohad Arazi: About 12 to 15 percent of our business focuses on emergency medicine and critical care. While these fields are often grouped together, they have distinct needs. Time is crucial in emergency care, emphasizing the importance of rapid AI-enabled triage. 

For instance, the eFAST protocol in EMED assesses key organ systems in the chest and abdomen, requiring proficiency in ultrasound operation due to the varied anatomy and conditions encountered. Emergency medicine physicians are typically proficient users of point-of-care ultrasound, prioritizing efficiency over skill acquisition.

Voice-controlled AI features are also invaluable in emergency medicine, particularly during interventional procedures like line placements or nerve blocks. In situations where practitioners need to multitask, such as in ambulances with limited staff, voice controls enable seamless ultrasound operation, enhancing overall patient care.