Highlights & Summary
From ViVE 2022 to exciting regulatory approvals, product launches, partnerships, and acquisitions for the digital health space, Q1 2022 is off to an eventful start. We’ve rounded up the big headlines for you.
Overarching Industry Updates
- ViVE 2022: AMA launches new initiative aimed at equitable health innovation
Project Launch | AMA
- Taiwanese electronics giant Foxconn reveals digital health foray
Partnership | Foxconn, Taiwan Biophotonic Corp., and Industrial Technology Research Institute
- Report names Europe’s digital health app reimbursement leaders and laggards
Report | Reimbursement Companies
AI / Imaging
- Viz.ai's cerebral aneurysms algorithm scores FDA clearance
Regulatory Approval | Viz.ai
- Qure.ai’s breathing tube placement AI technology receives FDA clearance
Regulatory Approval | Qure.ai
- GLEAMER scores FDA 510(k) for AI-enabled fracture detection
Regulatory Approval | GLEAMER
- Butterfly Network rolls out new ultrasound platform
Platform Launch | Butterfly Network
- Captions Health’s Interpretation Automated Ejection Fraction Software receives FDA Approval
Shoutout: Regulatory Approval* | Captions Health
- Philips AI-enabled Precise Image (Precise Suite) receives FDA Approval
Shoutout: Regulatory Approval* | Philips
*These shoutouts are based on updates to the FDA database and not formal company announcement
Disease Management / Digital Therapeutics
- Abbott's CardioMEMS HF System Receives FDA Approval to Support Patients Battling Earlier-stage Heart Failure
Regulatory Approval | Abbott
- GoodRx Agrees to Acquire vitaCare, A Tech-Enabled Pharmacy Services Platform
Acquisition | GoodRx, vitaCare
- Digital pharmacy Alto scores $200M from Softbank Vision Fund
Funding | Alto, Softbank Vision
- Insulet's Omnipod 5 Cleared by FDA
Regulatory Approval | Insulet
Informatics / Healthcare IT Solutions
- Royal Philips rolls out at-home ECG system for decentralized clinical trials
Product Launch | Royal Phillips
- Labcorp Launches Labcorp OnDemand Digital Health Platform
Platform Launch | Labcorp
- Microsoft, Johnson & Johnson Medical Device Companies team up on digital surgery ecosystem
Partnership | Microsoft, Johnson & Johnson Medical Device Companies
- Terumo and Corazon Sign Collaboration and Co-Marketing Agreement
Partnership | Terumo and Corazon
Overarching Industry Updates
1 | ViVE 2022: AMA launches new initiative aimed at equitable health innovation
At ViVE 2022, the American Medical Association (AMA) announced its three-year plan to improve racial justice and advance health equity, outlining five strategies for doing so. These strategies include: understanding and implementing anti-racist strategies regarding practices, policies, and culture in the medical community; forging alliances with marginalized physicians and other stakeholders; educating physicians on how to dismantle social drivers that contribute to health inequities; provide equitable opportunities to advancing digital health; acknowledge their own past wrongdoings.
2 | Taiwanese electronics giant Foxconn reveals digital health foray
Foxconn Technology Group, also known as Hon Hai Precision Industry Co., has announced a partnership with Taiwan Biophotonic Corp. (tBPC) and Industrial Technology Research Institute (ITRI) to create a long-distance care monitoring platform. ITRI’s background in electro-optics and information communication will guide the development of the platform as tBPC’s optical sensors are combined with Foxconn’s medical hardware and medical algorithms are incorporated into the software. This partnership marks communication technology company, Foxconn’s, entrance into the Southeast Asian medical device market. The digital health market in Asia is thought to potentially reach $100 billion by 2025.
3 | Report names Europe’s digital health app reimbursement leaders and laggards
Research2Guidance released a report in February discussing where Europe was on the roadmap to digital health app reimbursement. After Germany passed the Digital Healthcare Act (DiGA) in 2019, digital health apps listed in the DiGA directory were allowed to target publicly insured German residents. Several EU countries are hoping to follow suit. The leaders of this initiative are Germany, Belgium, and France; France is expected to launch an assessment framework similar to DiGA this year. “Fast followers” include Italy, Netherlands, Austria, Finland, Ireland, Luxembourg, Sweden, Denmark, Switzerland, and Estonia, whose health representatives have expressed interest in implementing something similar to DiGA. For the “fast followers” group, the first digital health app to receive access to the national health insurance plans averages about two years.
AI / Imaging
1 | Viz.ai's cerebral aneurysms algorithm scores FDA clearance
Viz.ai, a Forbes Next Billion-Dollar Startup 2021, has received FDA clearance for an AI algorithm that can detect cerebral aneurysms with 94% accuracy. Viz.ai, the leader in AI-powered clinical care coordination, will integrate this algorithm into their care coordination platform to reduce the latency period between aneurysm detection and clinical followup, imperative for critical conditions like aneurysms.
2 | Qure.ai’s breathing tube placement AI technology receives FDA clearance
Qure.ai, a startup backed by Sequoia Capital leveraging deep learning in radiology, has received FDA approval for its breathing tube placement algorithm (qXR-BT) supplementing its qXR platform used to detect abnormalities using Chest X-Rays. This breakthrough algorithm will automate the measurement of endotracheal tube measurements. A rapid and accurate placement of these tubes is paramount especially in the face of the COVID-19 pandemic and increased cases of mechanical ventilation.
3 | GLEAMER scores FDA 510(k) for AI-enabled fracture detection
Gleamer, a diagnostic imaging AI company, has received FDA approval for its bone trauma detection software: BoneView. BoneView is capable of detecting fractures, effusions, dislocations and bone lesions. A randomized clinical trial has shown that BoneView can reduce the number of missed fractures by 30% while reducing reading times by 15%. This tool aims to assist emergency department physicians, where 80% of diagnostic errors result from missed fractures.
4 | Butterfly Network rolls out new ultrasound platform
Butterfly Network is releasing a new ultrasound platform with the ability to integrate into clinical workflows, Butterfly Blueprint. The system is able to transmit data from Butterfly’s existing handheld ultrasound probe into the provider's electronic medical or health records via Compass software. This announcement was included as part of Butterfly Networks earnings call which noted a 35.3% increase in revenue 2021 over 2020.
Disease Management / Digital Therapeutics
1 | Abbott's CardioMEMS HF System Receives FDA Approval to Support Patients Battling Earlier-stage Heart Failure
Abbott’s CardioMEMS HF system, an implantable cardiac sensor, has received FDA clearance for an expanded patient population. The system was originally approved for Class III heart failure patients, and now is approved for class II heart failure patients. This expands access to the device to an additional 1.2 million U.S. patients. The device is implanted into a patient’s pulmonary artery in a minimally invasive procedure in order to monitor pressure changes and send data and alerts to the patient’s physician. The data provided for the approval was from the GUIDE-HF study, a randomized trial of 3,600 patients that demonstrated a 28% decrease in heart failure hospitalizations for those with the CardioMEMS system.
2 | GoodRx Agrees to Acquire vitaCare, A Tech-Enabled Pharmacy Services Platform
Leading consumer-facing digital healthcare platform, GoodRx, has entered an agreement to acquire vitaCare Prescription Services. VitaCare helps patients navigate insurance coverage and identify savings opportunities as well as offers a pathway for filling prescriptions. The acquisition is intended so GoodRx users will be able to expand their access to the necessary brand-name medications and decrease cost barriers. GoodRx will pay $150M in cash to acquire vitaCare with the transaction expected to be completed in mid-2022.
3 | Digital pharmacy Alto scores $200M from Softbank Vision Fund
Alto is a digital pharmacy that delivers medication to patients the same day the prescription is received. The company also offers an on-call pharmacist customers can chat with virtually regarding concerns or side effects. Alto recently announced a $200 million Series E round led by Softbank Vision Fund, the world’s largest technology-focused investment fund. In the last year, Alto had over $700 million in revenue and has already expanded to 12 markets in the US. In 2020, it also partnered with Hims & Hers, allowing Hims & Hers patients to select Alto as their preferred pharmacy.
4 | Insulet's Omnipod 5 Cleared by FDA
Insulet’s Omnipod 5, a tubeless system with smartphone app control, has been cleared by the FDA. The device is approved for those with type 1 diabetes. This system can improve quality of life for those with type 1 diabetes by automating insulin delivery. Every 5 minutes a continuous glucose monitoring value is sent to the smartphone which predicts glucose delivery for the next hour and adjusts insulin accordingly. The system will first be released to a limited market for further research and is then expected to be released to the broader market shortly after.
Informatics / Healthcare IT Solutions
1 | Royal Philips rolls out at-home ECG system for decentralized clinical trials
Royal Philips, a large European med tech company, has developed an at-home ECG system to support decentralized clinical trials. As participants wear the PCA 500 ECG body patch, their data is securely recorded and accessed via Philips’ cloud-based service. As part of a growing trend of increasing decentralization of clinical trials, this product aims to improve clinical trial attrition rates and will likely help increase accessibility and thus diversity of trials.
2 | Labcorp Launches Labcorp OnDemand Digital Health Platform
LabCorp launched its OnDemand Digital Health Platform from which individuals can purchase tests, collect samples by themselves at home, or schedule test appointments at a LabCorp patient service center. The OnDemand website offers popular tests, from wellness to COVID-19 to women’s health and fertility tests. LabCorp plans to also make additional OnDemand kit options available through physicians, health plans, and employers later this year.
3 | Microsoft, Johnson & Johnson Medical Device Companies team up on digital surgery ecosystem
Microsoft is collaborating with Johnson & Johnson Medical Device Companies (JJMDC) to expand JJMDC’s digital surgery products through Microsoft’s Cloud. JJMDC will utilize Microsoft’s Azure to create a digital surgery monitoring dashboard. The collaboration is part of a larger trend of increased personalization of surgical care through artificial intelligence and machine learning.
4 | Terumo and Corazon Sign Collaboration and Co-Marketing Agreement
Terumo Medical Corporation, global medical device manufacturer, has announced a collaboration and co-marketing agreement between their Terumo Health Outcomes division and Corazon Inc. Corazon is a provider focused on heart, vascular, neuroscience and orthopedic programs, as well as management and consulting services. Terumo’s ePRISM platform predicts patients who may have unanticipated outcomes following cardiac procedure. Corazon’s E3 accreditation approach supports customers by offering higher quality cardiac programs based on precision medicine. The Corazon E3 accreditation coupled with the Terumo ePRISM in this partnership will allow for increased guidance of patients to appropriate care programs and aims to improve patient outcomes overall.
Headlines are curated by Olivia Qiu, Lauren Brodsky, Katherine Erickson, and Rishi Kayathi.