DoMore Diagnostics announced that it received CE mark approval in Europe for its Histotype Px Colorectal deep learning algorithm. Oslo, Norway-based DoMore designed its Histotype Px Colorectal deep learning algorithm to predict colorectal cancer patient outcomes based on analysis of digital histology images. The company said in a news release that the algorithm, which builds […]
Quidel, Ortho Clinical Diagnostics combine to form in vitro diagnostics company
Quidel (Nasdaq:QDEL) announced today that it completed its $6 billion acquisition of Ortho Clinical Diagnostics (Nasdaq:OCDX). In December 2021, San Diego-based Quidel and Ortho Clinical Diagnostics came to an agreement under which the former would acquire the latter for $24.68 per share of common stock, using a combination of cash and newly issued shares in […]
U of Maryland scientist to set up NIH’s new Advanced Research Projects Agency for Health
U.S. Dept. of Health and Human Services (HHS) announced that it formed a new research project agency for health. HHS Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health (NIH). Adam H. Russell was appointed as acting deputy […]
FDA grants IDE for MedAlliance’s sirolimus-eluting balloon
MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR drug-eluting balloon. Geneva, Switzerland-based MedAlliance designed its Selution SLR (sustained limus release) novel sirolimus-eluting balloon to provide a controlled sustained drug release, similar to a drug-eluting stent. Get the full story at our sister site, Drug Delivery Business News.
Medtronic ‘hopeful’ on FDA clearance for next-gen diabetes tech in FY 2023
The Medtronic (NYSE:MDT) diabetes business sputtered in the fourth quarter but could be bolstered by a major regulatory nod this year. The Fridley, Minnesota-based company saw revenues for its diabetes arm fall by 7.7% year-over-year in the fourth quarter amid overall misses on both sales and adjusted earnings per share compared to Wall Street’s expectations. […]
Bigfoot Biomedical adds former Insulet VP as chief commercial officer
Bigfoot Biomedical announced today that it appointed former Insulet executive Matt Rainville as its chief commercial officer. Rainville’s role includes leading the growth of Milpitas, California–based Bigfoot Biomedical’s fully commercial Bigfoot Unity diabetes management program as the company looks to expand access to its offerings. Bigfoot Unity aims to simplify CGMs and the data they produce […]
Medtronic, DaVita to form new kidney care company
Medtronic (NYSE:MDT) and DaVita (NYSE:DVA) today announced the intent to form a new medical device company for kidney care. The new, independent company — dubbed “NewCo” for now — aims to enhance the patient treatment experience and improve overall outcomes for kidney care patients. According to a news release, the new company will bring together […]
Medtronic stock down on Q4 earnings miss
Medtronic (NYSE:MDT) shares are down today on fourth-quarter results that missed the consensus forecast. Shares of MDT were down more than 4% to $100.56 apiece in morning trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up slightly. The Fridley, Minnesota-based medtech giant posted profits of $1.5 […]
AccuPulse raises $10M Series A
AccuPulse Medical Technology announced that it recently raised more than $10 million in a Series A funding round. Shenzhen Qianhai Capital led the funding round, with Shanghai Biomedical Industry Equity Investment Fund and Yuanbio Ventures jointly investing. AccuPulse develops electrophysiology technology designed as a one-stop solution to treat cardiac arrhythmias, especially atrial fibrillation. Its product […]
Baxter expects sales growth momentum through 2025
Baxter (NYSE:BAX) today issued long-term financial guidance that projects growth over the next three years. Shares of BAX were up 1.5% at $74.98 per share in midday trading today in response to the news. Deerfield, Illinois-based Baxter expects sales growth between 4% and 5% on a compounded annual basis from 2022 through 2025, with free […]
Vivera picks up new patent for electronic dose-controlled drug delivery devices
Vivera announced today that it received a third U.S. patent for its Zicoh electronic dose-controlled drug delivery device portfolio. Newport Beach, California-based Vivera’s latest patent from the U.S. Patent and Trademark Office (USPTO) secures Zicoh’s rights as a smart dosing system with automated delivery, measurement, and management for oral format medications, including pills, capsules and […]