BioWorld - Friday, December 26, 2025
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
  • Hourglass on glowing circuit board, symbolizing time and technology

    FDA’s LDT loss tops regulatory stories of 2025

    The U.S. FDA’s final rule for regulation of lab-developed tests was destined to be controversial at best and exceptionally susceptible to legal challenge according to more than one legal opinion. The inevitable legal challenge succeeded wildly in a decision rendered in district court in March 2025, marking one of the rare instances in which the courts thwarted FDA rulemaking and thus is easily the regulatory story of the year for 2025. Attempts to regulate AI in the U.S. and Europe also dominated the regulatory landscape.

  • Crescom wins FDA clearance for bone analysis

    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 growth plate status assessed by hand and wrist X-ray imaging. Prior clinical trial results demonstrated MediAI-BA had specialist-level accuracy, recording a mean absolute deviation (MAD) of 0.39 years.

  • FDA’s LDT loss tops regulatory stories of 2025

    The U.S. FDA’s final rule for regulation of lab-developed tests was destined to be controversial at best and exceptionally susceptible to legal challenge according to more than one legal opinion. The inevitable legal challenge succeeded wildly in a decision rendered in district court in March 2025, marking one of the rare instances in which the courts thwarted FDA rulemaking and thus is easily the regulatory story of the year for 2025. Attempts to regulate AI in the U.S. and Europe also dominated the regulatory landscape.

  • Crescom wins FDA clearance for bone analysis

    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 growth plate status assessed by hand and wrist X-ray imaging. Prior clinical trial results demonstrated MediAI-BA had specialist-level accuracy, recording a mean absolute deviation (MAD) of 0.39 years.

  • Vaccine policy and the terrible, horrible, no good, very bad year

    Driven by a deeply antiscientific political agenda, the current U.S. government is not just sabotaging some of the most groundbreaking technology that has been developed in the past decades. It is also destroying the country’s past successes, such as measles elimination and the reduction of hepatitis B infections in infants to near zero.

  • In 2025, autoimmune work notches scientific, economic successes

    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 old. But the discoveries were the basis for ongoing research into how to prevent autoimmunity that notched significant wins in 2025, in both basic research and in the clinic.

  • Holiday notice

    BioWorld's offices will be closed in observance of Christmas. No issues will be published Thursday, Dec. 25 or Friday, Dec. 26.

BioWorld Insider podcast

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Digital health

  • 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...
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Today's news in brief

Regulatory

Financings

  • Ultromics

    Go Red for Women Venture Fund invests in Ultromics

    Cardiovascular
    Ultromics Ltd. secured a strategic investment from the American Heart Association's Go Red for Women Venture Fund to advance the use of its technology to help clinicians better identify women suffering from heart failure with preserved ejection fraction (HFpEF). The condition goes undiagnosed in...
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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

  • 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...
  • Back pain

    Companion Spine gains FDA PMA for DIAM spinal implant

    Regulatory
    Companion Spine SAS received premarket approval from the U.S. FDA for its DIAM spinal stabilization system, for treatment of degenerative disc disease. The approval comes as the company recently completed the acquisition of a number of assets from Xtant Medical Holdings Inc., including Paradigm...
  • Businessman signing documents

    Teleflex selling 3 business units for $2.03B

    Cardiovascular
    Teleflex Inc. reported plans to sell its Acute Care, Interventional Urology and OEM businesses to two buyers for $2.03 billion. Intersurgical Ltd. will acquire the Acute Care and Interventional Urology units for $530 million. Additionally, private equity firms Montagu and Kohlberg are buying its...
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U.S.

Europe

  • Photo of researchers shaking hands

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

    Aging
    Siemens Healthineers AG became the latest company to sign a licensing agreement with Alzpath Inc. to use its pTau217 antibody in the development of a blood-based diagnostic assay for Alzheimer's disease. Alzpath previously signed deals with the likes of Roche AG and Beckman Coulter Diagnostics Inc....
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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...
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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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