MIT Media Labs spinoff Empatica Inc. secured the CE mark for its Aura system, a wearable solution for the monitoring and early alert of respiratory infections, including COVID-19. For use with people 14 and older, Aura is commercially available in Europe and the U.K., and for pilot purposes in the U.S. – pending FDA authorization. Aura’s algorithm analyzes vital signs from Empatica smartwatches, comparing data against the wearer’s historical baselines. In validation studies, Aura was able to detect patients with possible H1N1 influenza, rhinovirus or SARS-CoV-2 infection with 0.94 sensitivity. Detection occurred on average two days after infection.
The U.S. FDA cleared Alivecor Inc.'s Kardia AI V2 interpretive electrocardiogram (ECG) algorithm for use in its personal ECG app and devices. Currently, the Kardia line permits consumers to take a 30-second medical grade ECG at home and instantly see whether they are exhibiting symptoms of atrial fibrillation, bradycardia, tachycardia or have normal heart rhythm.
Med-tech IPOs continue to make it out onto a strong stock market, even as global economic uncertainty prevails amidst the unfolding pandemic. Single-cell biology research company Berkeley Lights Inc. priced an upsized IPO to raise $178.2 million to back its tools that are used to help develop antibody therapeutics, cell therapies and, more broadly, synthetic biology products.
Machine learning-based diagnostics startup Dascena Inc. has won the U.S. FDA’s breakthrough device designation for its Previse algorithm, which is designed to predict acute kidney injury (AKI) before clinical symptoms. In early validation tests, Previse detected AKI more than a day before patients exhibited kidney damage or impaired function.
LONDON – Owkin Inc. added a further $18 million to its series A, bringing the amount raised in the round to $70 million and equipping the company to push forward with its federated learning approach to applying artificial intelligence (AI) to the analysis of health data.
Evidation Health Inc. reported good news this week in the form of the close of $45 million in series D funding, with an eye toward the expansion of its research platform, Achievement, to include virtual health. B Capital Group led the round, with Mckesson Ventures and Section 32 joining, in addition to existing investors Revelation Partners, Rethink Impact and SV Health Investors.
Researchers working as part of the Quantitative Imaging Biomarkers Alliance (QIBA) have recently validated an open-source algorithm that can be used to measure blood flow using existing 3D ultrasound technology from major manufacturers. They published their results in the June 30, 2020, issue of Radiology.
Startup Brightinsight Inc. is working to make the infrastructure behind digital health easily accessible to pharma and med-tech companies. To aid it on this path, the San Jose, Calif.-based company has raised a $40 million series B round to expand its capabilities and global reach.
HONG KONG – Contact tracing is seen as one of the more effective measures to contain the current COVID-19 pandemic. Now, an Israeli company may hold the solution with its app-free tech. Herzliya-based Wave Guard Technologies Inc. has an algorithm-based solution that allows government health care agencies to trace contacts of COVID-19-infected individuals accurately, effectively and in real time.
The U.S. FDA has given the greenlight to Eko Devices Inc.’s electrocardiogram (ECG)-based algorithm to aid in detecting patients with heart failure during the COVID-19 pandemic. The artificial intelligence (AI)-powered algorithm, which provides a quick way to screen for low ejection fraction, won FDA breakthrough status in December of 2019.
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