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BioWorld - Sunday, December 28, 2025
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Feb. 13, 2023

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Lena-Q51

Alercell’s Lena Q51 speeds time to diagnosis for leukemia

Diagnosing leukemia can be a straightforward matter that requires little more than analysis of a complete blood count. Too many white blood cells or too few red blood cells could herald leukemia. Flow cytometry may reveal the specific types of blood cell running amok—or not. Sometimes, leukemia stays in the bone marrow, making identification of the specific type more difficult. In those cases, a patient faces a more complex process that typically requires a bone marrow biopsy. Read More

Dianosic raises funds to finance solution to treat chronic allergic rhinitis

Dianosic SAS recently raised €4.7 million (US$5.04 million) from investors, in its second round of financing, and will use the funds to finance its preclinical in vivo testing and launch the first phase clinical trial for its Active Resorbable Intranasal Scaffold (ARIS) solution to treat chronic allergic rhinitis. Read More
Website of The Federal Trade Commission

FTC adopts more strident tone in revised version of health products compliance guide

The U.S. Federal Trade Commission (FTC) has updated a 1998 compliance guidance for health care products, much of which reiterates the provisions of the legacy edition. However, this updated version calls for randomized, controlled clinical trials to substantiate any claims made in connection with medical devices.  Read More

Shukun’s CT-FFR technology gets Chinese approval

Shukun Technology Inc.’s recently approved AI-based system to assess coronary arteries can get results in minutes, significantly speeding up diagnostics. Read More
Omni Legend - GE Healthcare

GE Healthcare rolls out its Omni Legend digital PET-CT scanner

GE Healthcare Technologies Inc. has just commissioned the first hospital site in the world to deploy Omni Legend technology, their next-generation 100% digital PET-CT scanner. The Cancer University Institute of Toulouse Oncopole (IUCT-Oncopole) in France is routinely using this new platform for cancer patients.  Read More

Med-tech gainers and losers for Feb. 6-10, 2023

The top 10 med-tech stock gainers and losers for the week. Read More

Appointments and advancements for Feb. 13, 2023

New hires and promotions in the med-tech industry, including: Axogen, Bioaffinity, Brainsway, Diagnamed, Egg Medical, Harbinger Health, Q Medical, Lifemd, Windgap Medical. Read More

Financings for Feb. 13, 2023

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

In the clinic for Feb. 13, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Irras, Lunit. Read More

Other news to note for Feb. 13, 2023

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alcon, Astrazeneca, Bigfoot Biomedical, Cleveland Diagnostics, Concerto Renal Services, Dexcom, Elekta, Endostream, GI Dynamics, Histosonics, Insulet, J&J, Lensx, Premier Business Inter, Quest, Rockwell Medical, Sophia Genetics. Read More

Regulatory actions for Feb. 13, 2023

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anavasi Diagnostics, Concept Medical, Hyperfine. Read More

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