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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Oct. 25, 2023

View Archived Issues
Ekos Flotriever

Real-world study: Less bleeding with Ekos than Flowtriever in PE

An analysis of real-world data pulled from Truveta’s electronic health records of 30 U.S. health care systems found that patients treated for pulmonary embolism (PE) using Boston Scientific Corp.’s Ekos endovascular system had lower rates of adverse events, particularly intracerebral hemorrhage, than those treated with Inari Medical Inc.’s Flowtriever system. Read More
Anteris Duravr

Anteris provides update on biomimetic valve for aortic stenosis

Anteris Technologies Ltd. presented multiple sessions at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 annual meeting in San Francisco this week on its novel Duravr biomimetic heart valve, a balloon-expandable, single-piece transcatheter aortic valve designed to closely replicate the shape and performance of a human aortic valve. The device was used for the first time earlier this year in a valve-in-valve replacement procedure and began its early feasibility study, both of which were reviewed at the cardiology meeting.

Read More
Vivio System

Ventric gets FDA clearance for heart failure diagnosis system Vivio

Ventric Health Inc. received U.S. FDA 510(k) clearance for its Vivio system, a mobile, non-invasive medical device that can aid in the diagnosis of heart failure. With early diagnosis crucial for treating and managing the condition, Vivio uses advanced algorithms to detect elevated left ventricular end diastolic pressure (LVEDP) in less than five minutes and can therefore improve clinical and health outcomes. Read More
Vuno

FDA clears Vuno’s AI-based MRI reading software for early Alzheimer’s detection

Vuno Inc. gained a U.S. FDA’s 510(k) clearance for its artificial intelligence (AI)-powered brain quantification device, Vuno Med-Deepbrain, to diagnose possible dementia in patients “even before mild cognitive impairment.” Read More
Monica Bertagnolli, nominee for NIH director

Despite chair’s opposition, US NIH nominee gets HELPing hand

After nearly two years with an unconfirmed acting director at its helm, the U.S. NIH is one step closer to finally having Senate-confirmed leadership to steer the agency in a time pressed with political agendas, pandemic concerns and the potential for what could be life-altering innovations. The Senate Health, Education, Labor and Pensions (HELP) Committee voted 15-6 Oct. 25 to favorably report Monica Bertagnolli’s nomination to the full Senate for a confirmation vote as the next NIH director. Read More

US Congress, courts provide push, pull on EPA ethylene oxide rulemaking

The U.S. Environmental Protection Agency (EPA) has struggled to devise a final rule regarding regulation of ethylene oxide (EtO) after several years, a regulatory activity that has device makers concerned about domestic capacity for sterilization. Read More

Exagen hit with $650K fine for payment of specimen processing fees

Exagen Diagnostics Inc., of Vista, Calif., has agreed to pay slightly more than $653,000 to resolve allegations that it had paid specimen processing fees to physicians to induce those physicians to use Exagen’s lab tests. Read More

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Appointments and advancements for Oct. 25, 2023

New hires and promotions in the med-tech industry, including: Glooko. Read More

Financings for Oct. 25, 2023

Med-tech firms raising money in public or private financings, including: Lentechs. Read More

In the clinic for Oct. 25, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Edwards Lifesciences, Jenavalve Technology, Theranica. Read More

Other news to note for Oct. 25, 2023

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Curium, Diadem, Imeka, Johnson & Johnson, Magnus Medical, Memed, Piur, Quanterix, Quest, T2 Biosystems. Read More

Regulatory actions for Oct. 25, 2023

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, RF Medical, Ventric Health. Read More

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