Welldoc announced today that it received another FDA 510(k) clearance for its BlueStar diabetes treatment platform.
Columbia, Maryland-based Welldoc’s new clearance for BlueStar — the ninth in total — expands insulin dosing support to most types of insulin, including bolus and premixed insulin titration for type 2 diabetes.
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Brittany Gould testified on Tuesday that she had taken two Theranos blood tests at a Walgreens location in Arizona that both indicated her hCG levels were dropping, according to multiple media reports.
Gould’s nurse practitioner Audra Zachman received the Theranos test results and told her that the results indicated that she was miscarrying and the pair allegedly discussed terminating the pregnancy due to the test results, Silicon Valley News reports.
However, Gould testified that she took three other tests during her early pregnancy through Quest Diagnostics – one prior to the Theranos test and two after – th…
Abbott (NYSE:ABT) announced today that it received FDA approval for its Epic Plus and Epic Plus Supra stented tissue valves.
The approval offers improved therapy options for people with aortic or mitral valve disease through the next-generation devices that build off of Abbott’s Epic surgical valve platform, according to a news release.
Epic Plus, a bioprosthetic valve, does not require the long-term use of blood-thinner medication, making them the recommended option for those who can’t take blood thinners or those who are over 70 years of age (a group with an increased bleeding risk from such medicines).
Abbott enhanced the Epic Plus platform with more radiopaque markers to make it easier for doctors to navigate if future transcatheter procedures are needed. Additionally, the new valves are designed to deliver long-term performance and durability with Abbott’s unique anticalcification technology.
The Epic Plus mitral holder help…
The Chicago Tribune reported that production of the BinaxNow rapid COVID-19 tests will begin at the Gurnee, Illinois-based facility within the coming weeks as an Abbott spokesperson confirmed to the outlet that the company is hiring for temporary positions, starting pay at $20 per hour with priority given to those who previously worked at Abbott.
As vaccination rates soared and COVID-19 cases dropped in the beginning of the summer, Abbott halted production of the tests in multiple locations. In July, Abbott laid off about 300 employees at its Westbrook, Maine, facility and another 100 at its Scarborough, Maine factory. At the same time, the company closed the Gurnee, Illinois, plant that added 2,000 workers to aid in scaling up testing capacity in September 202…
On behalf of diagnostic maker Hologic, the Gallup World Poll surveyed more than 60,000 women and girls (age 15 and older) across the world to measure action and attitudes about women’s health, focusing on preventive care, opinions of health and safety, emotional health, individual health and basic needs.
Those five factors explain more than 80% of women’s average life expectancy at birth and are used in the Global Women’s Health Index to rank countries and territories, Hologic said in a news release. For example, heart disease is the leading cause of death globally, but only about one in three women are estimated to have had their blood pressure tested in the last 12 months.
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The new CT system includes a new 75 cm wide-gantry, 40 mm detector coverage and lower table position designed to accommodate high body mass index (BMI) patients and trauma cases that would otherwise be too delicate to maneuver in a smaller size gantry, according to a news release.
GE Healthcare touts the platform as capable of offering clinicians a collection of artificial intelligence (AI) technologies that automate and simplify time-consuming tasks to increase operational efficiency and free up time for clinicians to deliver more personalized care to more patients.
Effortless Workflow, a new suite of AI solutions, offers accurately personalized automatic scans for each patient while requiring less effort from the CT technologist, GE Healthcare said.
Revolution Ascend uses a dedicated, deep neural network…
Medical device developer Nanodropper took home top honors from the awards ceremony, held Monday at the University of Minnesota.
“We have created an eyedrop bottle adaptor that will save billions in medication waste, one drop at a time,” Nanodropper CEO Allisa Song said.
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The robotic surgery company’s shares were up more than 19% to $15.05 by midday today. During the company’s first day of trading yesterday, shares rose 2% to $12.60 apiece, even as the Dow Jones Industrial Average fell about 600 points.
In April, the surgical robotics company announced that it would go public through a $1.1 billion merger with the special purpose acquisition corporation D8 Holdings — a deal that the SPAC’s shareholders approved on Sept. 15. The roughly $220 million in proceeds from the SPAC merger is expected to fund the further development and planned commercialization of the single-incision Vicarious system, which received FDA breakthrough device designation in 2019.
Vicarious’ robot includes features such as arms that replicate human motion, and it boasts 9 degrees of f…
Nuwellis (NSDQ:NUWE) announced today that it received CE mark approval for its 24-hour blood circuit set to be used with the Aquadex SmartFlow.
Eden Prairie, Minnesota-based Nuwellis — formerly CHF Solutions — can now market the 24-hour blood circuit set (UF 500-24 Hour) in the European Union and in other locations that recognize the CE mark.
According to a news release, the new device offers expanded access to ultrafiltration among patients who need no more than 24 hours of Aquadex therapy in the inpatient setting. Aquadex, a fluid management system that uses ultrafiltration to restore fluid balance in patients experiencing fluid overload, most recently received FDA 510(k) clearance for use in pediatric patients weighing 20 kg or more. Beyond treating heart failure, the device can be used in these situations with pediatric patients and in critical care.
The circuit can also provide a more economical solution for hospitals treating patients in the outpat…
IVX Health announced today that it completed a $100 million Series F minority investment round from Great Hill Partners.
Nashville, Tennessee-based IVX plans to utilize the funding to accelerate its entry into new markets in 2022 and beyond in its effort to make its outpatient infusion centers the country’s preferred destination for pharmaceutical care for patients with complex conditions.
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Boston Scientific today announced that is has entered an agreement to acquire Devoro Medical for more than $269 million.
Marlborough, Massachusetts-based Boston Scientific has been a strategic investor in Devoro Medical since 2019, according to the company. It has an equity stake of approximately 16%. The transaction will consist of an upfront payment of approximately $269 million for the 84% stake that is not owned and up to $67 million upon achievement of certain clinical and regulatory milestones.
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“We’re sitting at the tip of our chair waiting for the phone call that the product will be approved,” Medtronic EVP and EMEA President Rob ten Hoedt said Friday.
Fridley, Minnesota-based Medtronic (NYSE:MDT) filed for European approval in March, starting a process that takes about six to nine months. Medtronic’s now “in shooting range,” ten Hoedt said.
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