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BioWorld - Saturday, January 3, 2026
Breaking News: BioWorld 2025 Year in ReviewBreaking News: BioWorld MedTech 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sector
  • Black dollar sign on ombre blue background

    Med techs prune, purchase to rebalance product portfolios

    Four optimization trends dominated the med-tech industry in 2025. Growth-driven acquisitions propelled major players into hot markets, while strategic realignments at several large companies prompted notable exits as well as a few tuck-in deals. Spin-offs continued their mixed performance, with several companies on track for significant splits and others changing plans. Private equity entered — and exited — with leveraged buy outs, and a record-setting cash out.
  • Robotic-assisted surgical systems gained momentum in 2025

    In 2025, the momentum behind robotic-assisted surgical systems continued to accelerate on the back of increasing demand for minimally invasive procedures. In many parts of the world, these technologies are reshaping surgical procedures by improving precision and efficiency through high resolution imaging, AI and refined instrument control. This is resulting in fewer complications, faster recovery and improved patient outcomes.
  • Med techs prune, purchase to rebalance product portfolios

    Four optimization trends dominated the med-tech industry in 2025. Growth-driven acquisitions propelled major players into hot markets, while strategic realignments at several large companies prompted notable exits as well as a few tuck-in deals. Spin-offs continued their mixed performance, with several companies on track for significant splits and others changing plans. Private equity entered — and exited — with leveraged buy outs, and a record-setting cash out.
  • Robotic-assisted surgical systems gained momentum in 2025

    In 2025, the momentum behind robotic-assisted surgical systems continued to accelerate on the back of increasing demand for minimally invasive procedures. In many parts of the world, these technologies are reshaping surgical procedures by improving precision and efficiency through high resolution imaging, AI and refined instrument control. This is resulting in fewer complications, faster recovery and improved patient outcomes.
  • Science in 2025: the best of the rest

    A review of 2025's noteworthy advances in medical research, including GLP-1 receptor agonists as anti-aging drugs, tumor-agnostic therapies and xenotransplants.
  • LINC01116 has prognostic value in lung cancer, study shows

    Long noncoding RNAs (lncRNAs) have emerged as potential markers of disease, since they associate with proteins that regulate gene expression, translation or stability, among others, and where hypoxia might play a role in this scenario. In recently published work, researchers analyzed clinical data from patients with lung adenocarcinoma to identify hypoxia-modulated lncRNAs in vivo and in vitro, and which could correlate with prognosis.
  • Holiday notice

    BioWorld's offices were closed Thursday, Jan. 1. No issue was published.
  • Today's news in brief

    BioWorld MedTech briefs for Jan. 2, 2026.

BioWorld Insider podcast

Play buttonThe opioid crisis may not be front and center anymore, but it’s raging still. Elysium Therapeutics Inc. CEO Greg Sturmer talks about his firm’s candidate for a solution to the medical and societal problem.
Listen now

Digital health

  • 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...
  • Illustration showing cross-section of bladder with tumor on bladder wall

    Minze, Medtronic partner on overactive bladder care in EMEA

    Urology
    Minze Health NV signed a three-year agreement with Medtronic plc to bring its Minze Diary Pod, an app-controlled automated urine collection device, to markets across the EMEA region. The partnership aims to enhance the support services available for patients with overactive bladder receiving sacral...
More in Digital health

Today's news in brief

  • Appointments and advancements for Jan. 2, 2026

  • Financings for Jan. 2, 2026

  • In the clinic for Jan. 2, 2026

  • Other news to note for Jan. 2, 2026

  • Regulatory actions for Dec. 31, 2025

Regulatory

  • CMR, Medtronic secure FDA nod for robotic surgical systems

  • FDA declines to clarify on-site access restrictions in BiMo final

  • 2025 a busy year for device makers as defendants

  • FDA eyes new contracting mechanism for venture capital

  • Skin substitute LCDs withdrawn, spending concerns remain

  • ONC to slash regulation for electronic health records

  • FDA’s LDT loss tops regulatory stories of 2025

  • MDCG eyes breakthrough devices pilot in mid-2026

  • Payers faced traditional, novel payment policies in 2025

  • Edwards lands first FDA approval for transcatheter MVR

Financings

  • Shenzhen Edge Medical Co. Ltd.’s Multi-Port Endoscopic Surgical Robot

    Surgical robotic maker Shenzhen Edge announces $154M HKEX IPO

    Gastrointestinal
    Surgical robotics maker Shenzhen Edge Medical Co. Ltd. reported its initial public offering on the Hong Kong Stock Exchange to raise HKD$1.19 billion (US$154 million) to advance its pipeline of surgical robotic systems and expand its geographic footprint to markets outside China.
  • Med-tech IPOs shoot for the stars in 2025

    Deals and M&A
  • 2025 leaves a few bright spots in Europe’s med-tech sector

    Europe
  • Laparoscopic instruments maker Livsmed tops 2025 Kosdaq IPOs

    Cancer
  • Go Red for Women Venture Fund invests in Ultromics

    Cardiovascular
More in Financings

Newco news

  • India map on technology concept background

    Bayosthiti AI to build India-specific RNA sequencing ecosystem

    Cancer
    Bayosthiti AI Pvt Ltd. aims to make RNA sequencing and AI-based preventive health care affordable and accessible for the Indian market, leveraging intellectual property from its parent company, Biostate AI Inc.
  • 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...
  • Tulyp emerges from stealth with pressure-driven perfusion system

    Clinical
  • Symbyx light therapy shows sustained benefits in Parkinson’s

    Gastrointestinal
  • SK Bio, Eurofarma launch Mentis Care for digital epilepsy care

    Artificial intelligence
  • Trogenix raises £70M series A for glioblastoma gene therapy trial

    Financings
More in Newco news

Deals and M&A

  • 2025 med tech mergers and acquisitions

    Merger
    The biggest mergers and acquisitions in med tech in 2025.
  • Advanced Biomed’s A+Perfusc 3D cell culture system

    Advanced Biomed sells Hong Kong subsidiary for $23k

    Diagnostics
    Advanced Biomed Inc. reported Dec. 30 the sale of its wholly owned Hong Kong subsidiary, Advanced Biomed (HK) Ltd., and related intellectual property to buyer Wei Ha Hui for $23,000.
  • Illustration of CAR T cell therapy in rheumatoid arthritis

    In 2025, autoimmune work notches scientific, economic successes

    Immune
    In October, the Nobel Committee awarded the 2025 Nobel Prize in Physiology or Medicine to Shimon Sakaguchi, Mary Brunkow and Fred Ramsdell for their discoveries in the field of autoimmunity. As has become typical for the scientific Nobel Prizes, the award-winning research is by now several decades...
  • Collage of businesspeople

    November lifts med-tech deal value to $780M amid uneven 2025

    Med-tech M&A value in 2025 totaled about $38.99 billion through November, reflecting a clear slowdown from 2024’s $57.92 billion and well below the peak years of 2021 and 2022, when 11-month totals exceeded $119 billion and $132 billion, respectively. Activity this year has been uneven, with a...
  • IPO puzzle pieces

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

    IPO
    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...
More in Deals and M&A

U.S.

  • Intuitive sees continued da Vinci growth amid rising competition

  • Insider trading defendant hit with fines under civil code

  • A pleasant shock: Abbott’s Volt PFA system snags early FDA approval

  • MAC attack on CPT code for hypoglossal nerve stimulation dings Inspire

  • Rare diseases drive November’s US drug approvals

  • ACC consensus supports quantitative coronary plaque analysis

  • White House steps in on preemption of state AI law

  • FDA’s final RWE guidance offers more details on IDE studies

  • DOJ arrests shed light on Medicare skin substitute controversy

  • Companion Spine gains FDA PMA for DIAM spinal implant

Europe

  • EU flags

    EU scrambled in 2025 to overcome problems with AI Act, device regs

    Regulatory
    The year 2025 will go down in med-tech history as remarkable for a number of things, but manufacturers doing business in the EU might be forgiven for thinking that it was a year for correction of self-inflicted wounds, even if those corrections won’t arrive in full form until 2026.
  • European Commission floats multiple fixes for MDR, IVDR

    Regulatory
  • Siemens, Alzpath sign deal on Alzheimer's diagnostic blood test

    Aging
  • Ebenbuild aims to transform lung care with digital twin tech

    Artificial intelligence
  • Alcon sweetens offer for Staar, major shareholders still unimpressed

    Deals and M&A
More in Europe

Asia-Pacific

  • PET imaging

    Radiopharm Theranostics’ RAD-101 meets brain metastases endpoints

    Clinical
    Radiopharm Theranostics Ltd.’s radiotracer RAD-101 met the primary endpoint in 92% of patients in the phase IIb imaging trial in brain metastases, according to interim results. To date, 11 of the 12 patients treated with RAD-101 (F18-Pivalate) achieved concordance with MRI (the primary endpoint) as...
  • 73 Chinese biotech, med-tech companies file for HK IPOs in 2025

    Analysis and data insight
    Seventy-three pharmaceutical, biotechnology and medical device companies from mainland China filed for IPOs in Hong Kong this year, a review by BioWorld found. In the second half of 2025, 43 new securities reports were filed on the Hong Kong Stock Exchange, increasing from the 30 applications in...
  • Epiminder’s AU$125M IPO sets stage for epilepsy breakthrough

    Financings
    Epiminder Ltd. raised AU$125 million (US$82.99 million) in its initial public offering on the Australian Securities Exchange to commercialize its Minder system, a long-term ambulatory electroencephalography monitoring device for epilepsy.
  • Saluda to expand spinal cord stimulation market in AU$231M IPO

    Financings
  • Diag-nose.io develops respiratory disease precision diagnostics

    Respiratory
  • China’s Cornerstone Robotics raises $200M series D round

    Financings
  • TGA updates ad guidelines to include social media

    Regulatory
More in Asia-Pacific

Clinical

  • Neuropace shows 77% reduction in seizures

    Neurology/psychiatric
    People with drug-resistant epilepsy have had few other options, but Neuropace Inc. appears on target to provide an alternative. The Nautilus trial of its responsive neurostimulation system for individuals with drug-resistant idiopathic generalized...
  • Cosmo data positive for first new hair-loss approach in decades

    Dermatologic
    Shares of Cosmo Pharmaceuticals NV rose sharply on Dec. 3 following top-line pivotal phase III data showing a statistically significant and clinically meaningful improvement in male androgenetic alopecia patients receiving clascoterone 5%, the...
  • Brainomix 360 Stroke increases endovascular thrombectomy rates

    Artificial intelligence
    Brainomix Ltd. reported the publication of a prospective real-world study demonstrating that its AI imaging platform, Brainomix 360 Stroke, significantly increased rates of endovascular thrombectomy (EVT) treatment, a minimally invasive surgical...
  • Fractyl procedure sustains weight loss after GLP-1s

    Diabetes
    Glucagon-like peptide-1 (GLP-1) receptor agonists clearly help patients shed pounds, but many regain all - or more - of the weight once they discontinue the medications. Fractyl Health Inc. could offer an enduring solution with its Revita...
  • Xeltis secures $55M for vascular access conduit

    Cardiovascular
    Xeltis BV secured €47.5 million in financing to help bring Axess, its vascular access conduit for hemodialysis, to the market. The funds include a venture debt package of up to €37.5 million from the European Investment Bank and €10 million from...
  • Edwards shows benefits of early TAVR in asymptomatic severe AS

    Cardiovascular
    Edwards Lifesciences Corp. released data from a health economics study done across nine countries in Europe which showed that early transcatheter aortic valve replacement in patients with asymptomatic severe aortic stenosis can deliver significant...
More in Clinical

BioWorld Insider Podcast

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.


Recent episodes:

  • Finding a better, longer-lasting fix in opioid overdose
  • Esperion Therapeutics CEO Sheldon Koenig
  • Trying this at home: Bioxcel steps closer to an sNDA for Igalmi
  • The importance of balancing AI and people in drug development
  • Two CEOs discuss bracing for tariffs, NIH grant cuts and
    gifting China biopharma leadership position
  • As biopharma investments stumble, med tech surges
  • Mega money well spent? Mammoth mergers fall short of the dream
  • Healing the health divide for women
  • Modifi gets creative on the rocky road to a multibillion-dollar buyout
  • A quantum leap into the future of drug development

View all

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