Mercy Bioanalytics Inc. stepped into the increasingly competitive early cancer detection field with a $41 million series A financing round to support its Halo liquid biopsy platform. Novalis Lifesciences led the oversubscribed round with participation from Sozo Ventures, Hatteras Venture Partners, Iselect Fund, American Cancer Society BrightEdge and Broadway Angels, an all-women venture capital group. Laboratory Corp. of America Holdings, Bruker Corp. and existing investors also contributed to the round.
Masimo Corp.’s Opioid Halo, an opioid overdose prevention and alert system, was granted de novo status by the U.S. FDA. The device detects opioid-induced respiratory depression, the primary cause of opioid deaths. The de novo authorizes the company to make Halo available over the counter and by prescription for use on individuals aged 15 and up.
Ixlayer Inc. expanded access to diabetes screening by offering its test via retailers, health systems and payers, making it easier for consumers to measure and track their blood glucose levels without requiring a doctor’s visit or prescription. If an individual’s test results indicate that they have or are at risk of developing diabetes, however, the company will offer to connect them with a health care provider available through the reseller’s network to discuss next steps.
Histosonics Inc., the developer of a non-invasive platform that uses sonic beams to destroy tissue, treated the first patient in its phase I study of the procedure as a treatment for kidney tumors at the Leeds Teaching Hospitals National Health Services Trust in the U.K.
Aural Analytics Inc. received a breakthrough device designation from the U.S. FDA for its Speech Vitals-ALS technology, a software application that collects and analyzes speech recordings to help monitor amyotrophic lateral sclerosis (ALS) in adults in clinic and home settings. The software could improve management of the devastating disease.
The U.S. FDA gave Bot Image Inc. a coveted threefer with 510(k) clearance for its Prostatid artificial intelligence (AI) software for detection, diagnosis and monitoring of prostate cancer using both standard MRI and a non-invasive bi-parametric MRI, which does not require a contrast agent.
Illumina Inc. released Connected Insights in a beta version for the U.S., following its commercial release in other selected countries. Connected Insights, an assay-agnostic, cloud-based software designed to streamline interpretation and reporting across next-generation sequencing (NGS) types, was initially developed for somatic oncology applications, the system will shortly also support whole genome sequencing for rare diseases.
March 17 brought neither good luck nor good news to Pear Therapeutics Inc. Just prior to the opening bell, the prescription digital therapeutics company reported that it had engaged MTSA Health Partners LP to explore strategic alternatives for the company. In addition, Pear filed an 8-K with the SEC withdrawing its revenue and operating guidance for fiscal 2022 and 2023 and indicating that it does not plan to hold a fourth quarter and full year 2022 earnings conference call and webcast.
An artificial pancreas system that draws on research conducted at the University of Virginia to effectively combine Dexcom Inc.’s continuous glucose monitor and Tandem Diabetes Care Inc.’s artificial intelligence-enabled insulin pump works effectively in children under 6 years of age with type 1 diabetes, a study published in the New England Journal of Medicine showed.
Free, no-prescription-required access to naloxone injectors and nasal sprays has reduced deaths from opioid overdoses by 11% in some communities, but they only work if someone with the reversal agent is available when a person overdoses. Many times, unfortunately, opioid users are alone when an overdose occurs. Resilient Lifescience Inc. hopes to save those lives, too. The company is developing a wearable patch that monitors vital signs and automatically administers naloxone when needed.
