BioWorld - Sunday, January 11, 2026
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  • PerQseal Elite

    Haemonetics completes €185M Vivasure acquisition

    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 support of its latest version of the Perqseal vessel closure device.

  • Haemonetics completes €185M Vivasure acquisition

    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 support of its latest version of the Perqseal vessel closure device.

  • Vicentra secures additional $13M for Kaleido insulin patch pump

    Investors poured a further $13 million into Vicentra BV for Kaleido, its insulin patch pump system, taking the total raised in the company’s series D financing round to $98 million. The funds come amid significant changes across diabetes technology, particularly the acceleration of patch pumps. Kaleido is one of the smallest, lightest, and most precise insulin patch pumps available.

  • Patent for wearable speech-sensing device filed

    Jun Chen, a tenured associate professor of bioengineering at the Samueli School of Engineering at the University of California Los Angeles (UCLA), leads a team developing a speech-sensing wearable patch. The technology translates the intricate muscle movements of the larynx into discernible speech.

  • OpenAI’s GPT Health nudges AI closer to FDA regulatory divide

    Generative AI has largely escaped the U.S. FDA’s regulatory purview up to now, but OpenAI seems poised to create a new source of regulatory angst for the agency. The company unveiled its ChatGPT Health Jan. 7, a large language model that when used professionally could land the company in the FDA’s regulatory crosshairs.

  • China slashes tariffs on some medical devices

    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 high-quality goods.

  • December IPOs power rebound year for med-tech financing

    Med-tech financing activity rebounded sharply in 2025, with total reported capital raised climbing to $39.55 billion, nearly doubling from $25.35 billion in 2024 and approaching pre-pandemic norms. The increase was driven largely by a surge in IPO activity, which reached $13.01 billion. In December, financing value reached $8.23 billion across 36 transactions, up from $4.73 billion in November.

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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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Regulatory

Financings

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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

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U.S.

Europe

  • Shanx Medtech IVD

    Shanx secures €15M to accelerate rapid antimicrobial testing

    Seed
    Shanx Medtech BV raised €15 million (US$17.5 million) in a seed funding round for its in vitro diagnostic platform for ultra-rapid antimicrobial susceptibility testing. The financing came from a range of sources including equity, grants and a loan, and will be used to accelerate the development,...
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Asia-Pacific

  • Map of Australia as blue circuit board, digital network

    TGA eyes do-over for conformity assessment procedures

    Regulatory
    Australia’s Therapeutic Goods Administration posted a proposed rework of the agency’s conformity assessment procedures that would align with EU regulations, but the agency stated clearly that it is aware of some of the hazards of further alignment with the troubled European regulations.

  • White House steps in on preemption of state AI law

    Regulatory
    The Trump administration has made known that it intends to foster rapid adoption of AI, starting with a repeal of an executive order (EO) issued by the Biden administration. Now, the White House has issued an EO that would override state AI law, a move that addresses a task that Congress to date...

  • Medline raises $6.3B in fourth med-tech IPO of December

    Deals and M&A
    Medline Inc. returned to the public markets with a blockbuster IPO of $6.26 billion, reportedly this year’s largest IPO globally. The upsized offering of more than 216 million shares at $29 per share will allow the medical supply giant to devote the entirety of the proceeds from its initially...
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Clinical

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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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