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Sean Whooley

DoMore Diagnostics wins CE mark for AI algorithm that predicts colorectal cancer outcomes

May 27, 2022 By Sean Whooley

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 […]

Filed Under: Diagnostics, Genomics/Molecular Diagnostics, Health Technology, Men's Health, Regulatory/Compliance, Software / IT Tagged With: CE Mark, DoMore Diagnostics

Quidel, Ortho Clinical Diagnostics combine to form in vitro diagnostics company

May 27, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, Genomics/Molecular Diagnostics, Mergers & Acquisitions, News Well, Orthopedics, Wall Street Beat Tagged With: Ortho Clinical Diagnostics, Quidel, QuidelOrtho

U of Maryland scientist to set up NIH’s new Advanced Research Projects Agency for Health

May 26, 2022 By Sean Whooley

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 […]

Filed Under: Pharmaceutical Tagged With: Dept. of Health & Human Services (HHS), National Institutes of Health (NIH), Personnel Moves

FDA grants IDE for MedAlliance’s sirolimus-eluting balloon

May 26, 2022 By Sean Whooley

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.

Filed Under: Cardiovascular, Drug-Device Combinations, Drug-Eluting Stents, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: FDA, MedAlliance

Medtronic ‘hopeful’ on FDA clearance for next-gen diabetes tech in FY 2023

May 26, 2022 By Sean Whooley

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. […]

Filed Under: Business/Financial News, Diabetes, Drug Pumps, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Patient Monitoring, Regulatory/Compliance, Wall Street Beat Tagged With: Medtronic

Bigfoot Biomedical adds former Insulet VP as chief commercial officer

May 26, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diabetes, Drug Pumps, Drug-Device Combinations, Featured, Health Technology, News Well, Patient Monitoring, Software / IT Tagged With: Bigfoot Biomedical, Personnel Moves

Medtronic, DaVita to form new kidney care company

May 26, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Dialysis, Featured, Mergers & Acquisitions, News Well Tagged With: DaVita Inc., Medtronic

Medtronic stock down on Q4 earnings miss

May 26, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, News Well, Wall Street Beat Tagged With: Medtronic

AccuPulse raises $10M Series A

May 25, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Funding Roundup, Vascular Tagged With: AccuPulse

Baxter expects sales growth momentum through 2025

May 25, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: Baxter

Vivera picks up new patent for electronic dose-controlled drug delivery devices

May 25, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Drug Pumps, Drug-Device Combinations Tagged With: Vivera

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