BioWorld - Thursday, January 22, 2026
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  • Cancer cells.

    Targetable ‘high-plasticity cell state’ important for cancer progression, drug resistance

    Cancer cells expand through mutations – but not just through mutations. They also change their behavior in the absence of underlying genetic alterations. Such plasticity helps the cells both adapt to the cellular stress fueled by out-of-control growth and resist targeted and chemotherapies alike. Investigators from Memorial Sloan Kettering Cancer Center and Huazhong Agricultural University have gained new insights into the underlying mechanisms of plasticity.

  • Targetable ‘high-plasticity cell state’ important for cancer progression, drug resistance

    Cancer cells expand through mutations – but not just through mutations. They also change their behavior in the absence of underlying genetic alterations. Such plasticity helps the cells both adapt to the cellular stress fueled by out-of-control growth and resist targeted and chemotherapies alike. Investigators from Memorial Sloan Kettering Cancer Center and Huazhong Agricultural University have gained new insights into the underlying mechanisms of plasticity.

  • Boston Sci secures CE mark for Embold system

    Boston Scientific Corp.’s intent to acquire Penumbra Inc. for $14.5 billion will not only allow it to expand its minimal invasive care portfolio in areas such as embolization and peripheral vascular disease, but to also reenter the neurovascular space, Kathleen Van Vlierberghe, vice president of Peripheral Interventions EMEA, told BioWorld.

  • FDA clears 11 Aidoc AI triage indications

    Aidoc Medical Ltd.'s Care AI foundation model secured 11 new U.S. FDA-cleared indications for use in emergency department triage. Now, with 14 total cleared indications enabling comprehensive evaluation and prioritization of abdomen CTs in a single workflow, Aidoc Care can help health systems identify critical findings more quickly and mitigate delays caused by overcrowding and imaging backlogs.

  • Advamed says LDT legislation still alive on the Hill

    The U.S. FDA’s final rule for regulation of lab-developed tests is now a part of regulatory litigation history, but Scott Whitaker, CEO and president of the Advanced Medical Technology Association, said that while Congress is still considering LDT legislation, any new legislation may differ substantially from previous bills.

  • NIH spared slash-and-burn in congressional spending agreement

    The good news is that the U.S. Congress is on track to pass a slate of fiscal 2026 spending bills before the current continuing resolution expires Jan. 30. So, barring any last-minute disputes or legislative hostage-taking, there should be no repeat of last year’s 43-day shutdown that impacted NIH grants and activities.

  • F.Med redefines the future of microsurgical robotics

    Microsurgery is performed to connect small human vessels, but the technical difficulty required to conduct this type of surgery is quite specialized and limits the number of surgeons who can perform microsurgery.

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Digital health

  • Regulatory icons

    FDA’s new general wellness guidance is no dramatic overhaul

    Regulatory
    The U.S. FDA’s reissuance of the 2019 guidance for general wellness products seems to carve out new territory for makers of wearables that make modest claims regarding health, but anyone who was expecting a clear break with the 2019 version of the guidance was almost certainly disappointed.
  • Crescom MediAI-BA

    Crescom wins FDA clearance for bone analysis

    Regulatory
    Crescom Co. Ltd., an AI musculoskeletal imaging company, gained U.S. FDA 510(k) clearance Dec. 24 for MediAI-BA, its AI-powered pediatric and adolescent bone age analysis software. Classified as a class II medical device, MediAI-BA evaluates bone age and suggests predicted adult height based on...
  • IPO stock market ticker

    Acryl raises $28M IPO, aiming to bridge medical divide with AI

    Financings
    Acryl Inc. debuted on South Korea’s Kosdaq Dec. 16, raising ₩42.12 billion ($28.5 million) in an IPO. Shares (KOSDAQ:0007C0) closed at ₩67,000 on the first day, up 243.5% from its offering price, before closing 30% down on Dec. 17 at ₩47,500. Seoul, South Korea-based Acryl sold 2.16 million shares...
  • South Korean won

    Cha Group to Acquire Majority Stake in Kakao Healthcare

    Deals and M&A
    Kakao Healthcare Corp. plans to secure ₩100 billion (US$68 million) through two investment deals with Cha Biomedical Group and outside investors by early next year. The transactions, expected to close by the first quarter of 2026, will make Cha the controlling shareholder of Kakao Healthcare with a...
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Newco news

  • Nephrodite's Holly renal replacement named breakthrough device

    Urology
    Nephrodite Inc.'s Holly, an implantable, continuous renal replacement system, received U.S. FDA breakthrough device designation as a novel and potentially life-changing treatment for end-stage kidney disease. The system is designed to enable continuous blood filtration and allow patients freedom to...

  • Levron emerges with cardio-respiratory physiology assist tech

    Clinical
    Levron Medical Ltd. recently exited stealth mode to advance its cardio-respiratory physiology assist technology, designed to treat heart failure by synchronizing the heart and lungs. The approach harnesses the natural ‘respiratory pump’ to assist cardiac function and create what the company claims...
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Deals and M&A

  • 10-28-Boston-Science_Global-Headquarters_Marlborough,-Mass

    Boston Sci swings for the fences with $14.5B Penumbra buy

    Cardiovascular
    Boston Scientific Corp. looked ready to keep steamrolling down the acquisition path, carrying the momentum from last year, with the news that it is acquiring Penumbra Inc., a company that makes devices for interventional therapies to treat vascular conditions such as stroke and aneurysm, for a...
  • Carvolix Cath lab

    Affluent becoming Carvolix after acquisitions

    Cardiovascular
    Affluent Medical SAS is becoming Carvolix after it entered into binding agreements to acquire Caranx Medical SAS for €16.6 million (US$19.34 million) and Artedrone SAS for €11.4 million. The aim is to create an integrated med tech company which will focus on revolutionizing cardiac valve...
  • PerQseal Elite

    Haemonetics completes €185M Vivasure acquisition

    Cardiovascular
    Haemonetics Corp. acquired Vivasure Medical Ltd. for €100 million (US$116 million) cash plus up to an additional €85 million (US$99 million) in contingent payments based on sales and other milestones. The deal continues nearly four years of increasing investment in Vivasure by Haemonetics in...
  • Gold-encircled handshake

    Gore inks deal for Conformal, snags stent approval

    Regulatory
    In a big week for W.L. Gore & Associates Inc., the company reported plans to acquire Conformal Medical Inc. and received U.S. FDA approval for its Viabahn Fortegra venous stent for use in the inferior vena cava, iliac and iliofemoral veins.
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U.S.

Europe

  • Rows of red and blue game pieces with hybrid center piece

    Cellbxhealth restructures for growth

    Cancer
    Cellbxhealth plc, previously called Angle plc, appointed CEO Peter Collins along with several non-executives to its board as it embarks on a new strategic direction. Over the past few months the company overhauled its management team, reduced its workforce by 60% and raised £8.2 million (US$11...
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Asia-Pacific

  • Illustration of colon with inset showing cancer

    Colostat, Genetype pairing sharpens cancer screening pathway

    Clinical
    Rhythm Biosciences Ltd. launched a new genetype colorectal cancer risk assessment clinical test that incorporates clinical and lifestyle risk factors alongside its established 140-SNP polygenic risk score to identify people at elevated risk of colorectal cancer. The test supports more targeted...

  • TGA considers a policy dealing with device shortages

    Regulatory
    The COVID-19 pandemic amplified concerns over medical device shortages, prompting the U.S. FDA to develop guidance on the topic in November 2023. Australia’s Therapeutic Goods Administration is eyeing a guidance to address the very same problem, although the agency seems wary of whether to formally...

  • China slashes tariffs on some medical devices

    Regulatory
    Beginning Jan. 1, 2026, China will apply provisional import tariff rates lower than the most-favored-nation rates on 935 items, the State Council announced. The move aims to boost collaboration between domestic and international sectors, and to leverage resources of both to expand the supply of...
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Clinical

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One-on-one with medical innovators

podcast microphone, sound waves on purple backgroundBreakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.


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