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BioWorld MedTech

Sun, Jul 27, 2025
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Self-amplifying mRNA technology underscored for next big pandemic
  • Tinted Euro symbol

    EU approves €403M package for med tech

     The European Commission approved up to €403 million ($472 million) in funding to support development of innovations in medical devices in the region. The funds will go towards 10 companies that incorporate novel digital and AI features into their solutions.

  • Device, drug makers weigh in on Janssen’s FCA case

    Janssen Pharmaceutical’s loss in a False Claims Act (FCA) case for the company’s HIV treatments resulted in judgments of roughly $1.6 billion – an outcome the company appealed to the Court of Appeals for the Third Circuit.
  • EU approves €403M package for med tech

     The European Commission approved up to €403 million ($472 million) in funding to support development of innovations in medical devices in the region. The funds will go towards 10 companies that incorporate novel digital and AI features into their solutions.

  • Device, drug makers weigh in on Janssen’s FCA case

    Janssen Pharmaceutical’s loss in a False Claims Act (FCA) case for the company’s HIV treatments resulted in judgments of roughly $1.6 billion – an outcome the company appealed to the Court of Appeals for the Third Circuit.
  • Cryofocus’ asthma device wins FDA breakthrough label

    Cryofocus Medtech (Shanghai) Co. Ltd. received U.S. FDA breakthrough device designation on July 24 for its cryoablation system for asthma. The Chinese med-tech’s stock (HKEX:6922) rose near 20% over two consecutive days on the Hong Kong Stock Exchange with the news, increasing from HK$5.00 ($.64) July 23 to HK$5.98 nearing the close of trading on July 25.
  • Brandon Capital closes sixth life sciences fund at AU$439M

    Brandon Capital Partners Pty Ltd., Australia’s largest life sciences venture capital firm, announced the final close of its sixth fund at AU$439 million (US$288 million), the VC’s largest fund to date.
  • Corium identifies agent in MS patch

    The first filing in the name of Grand Rapids, Mich.-headquartered Corium Innovations Inc. confirms the company formerly known as Corium Pharma Solutions Inc. is developing treatments for multiple sclerosis and ulcerative colitis that employ its proprietary Corplex transdermal patch technology.
  • Today's news in brief

    BioWorld MedTech briefs for July 25, 2025.

BioWorld Insider Podcast

Play buttonRobert Williamson, CEO of Triumvira Immunologics, and Hernan Bazan, CEO of South Rampart Pharma, discuss bracing for tariffs, NIH grant cuts and gifting China a biopharma leadership position.
Listen now

Digital health

  • Telehealth illustration

    CMS takes aim at skin substitutes, telehealth in 2026 doc fee draft

    Regulatory
    The U.S. Centers for Medicare & Medicaid Services (CMS) has pulled off the gloves when it comes to spending on skin substitutes in the draft Medicare physician fee schedule for 2026, proposing a payment methodology that would slash spending by 90%. However, the doc fee draft also proposes to...
  • Lunit

    Lunit, Microsoft to codevelop cloud-based clinical AI solutions

    Deals and M&A
    Lunit Inc. reported a new collaboration with Microsoft Corp. July 2 to jointly develop medical AI programs accessible on Microsoft’s Azure cloud platform.
  • MHRA logo

    MHRA tackles risk classification for digital mental health tech

    Regulatory
    The U.K. Medicines and Healthcare Products Regulator Agency dropped a guidance for digital mental health technologies that clarifies several key points, such as when the DMHT qualifies as software as a medical device.
  • Reset Moves action shot

    Reset Moves to promote well-being in children with neurodivergence

    Neurology/psychiatric
    Focused on promoting well-being amongst children with neurodivergence, Reset Moves Pty Ltd. created app-based games to help children not only focus with greater clarity, but also to better help them re-engage in certain settings.
More in Digital health

Today's news in brief

  • Appointments and advancements July 25, 2025

  • Financings for July 25, 2025

  • In the clinic for July 25, 2025

  • Other news to note for July 25, 2025

  • Regulatory actions for July 25, 2025

Regulatory

  • Roche receives CE Mark for Alzheimer’s rule out test

  • Korea, Japan ink medical device info sharing pact

  • Device sterilizers granted two-year EtO reprieve

  • PTAB to return to pre-pandemic hearing practice

  • MHRA eyes expanded reliance programs to boost patient access

  • FDA expands Boston Sci’s Watchman label to post-ablation

  • TGA feels the Brussels effect with adoption of EU combo products guideline

  • Palmetto wary of Prelude’s, Exact Sciences’ test for DCIS

  • US states continue to move deeper into FCA legislation

  • Australia awards AU$100M in grants to biopharma/med-tech incubators

Financings

  • HKEX exterior

    34 mainland China biotechs file for Hong Kong IPO in H1 2025

    Analysis and data insight
    Thirty-six biotechnology, pharmaceutical and medical device companies sought a capital raise on the Hong Kong Stock Exchange in the first half (H1) of 2025, a review by BioWorld found. Of those, 34 companies were from mainland China.
  • 34 mainland China biotechs file for Hong Kong IPO in H1 2025

    Analysis and data insight
  • Modi Ventures raises $88M in second health care fund

    U.S.
  • Avalyn secures $100M for inhaled pulmonary fibrosis candidates

    Respiratory
  • Cooler Heads chilling with $11M series A

    Cancer
More in Financings

Newco news

  • Actithera raises $75M series A for FAP-targeted radiopharmaceuticals

    Financings
    Actithera A/S is poised to bring small-molecule pharmacokinetics to radiopharmaceuticals after closing a $75.5 million series A that will fund initial clinical development of a candidate targeting the elusive fibroblast activation protein (FAP).
  • Alphadesign: AI creating proteins from scratch

    Science
    The Alphafold machine learning system for predicting a protein’s structure from its amino acid sequence has been adapted to make it possible to design de novo proteins that fold in a particular way and bind to prespecified target proteins. The sister system, called Alphadesign, works by generating...
  • Zip Diagnostics develops first rapid POC test for scabies

    Infection
    Zip Diagnostics Pty Ltd., Menzies School of Health Research and Axxin Pty Ltd., a Melbourne, Australia-based diagnostic instrumentation manufacturer, partnered to develop a rapid diagnostic test for scabies, a skin parasite that affects more than 200 million people each year.
  • Wearoptimo’s hydration sensor outperforms gold standard tests

    Clinical
  • Patent filed for multiweek, multitarget CGM-like wearable sensor

    Cardiovascular
  • Updoc patents AI-powered diabetes management platform

    Diabetes
  • Trio of neuro disease-focused firms highlighted at KIMES 2025

    Cardiovascular
More in Newco news

Deals and M&A

  • Heartflow FFRCT analysis Credit: Heartflow Inc.

    Heartflow pumps up med tech IPOs

    Cardiovascular
    Heartflow Inc. continued the steady rhythm of med-tech companies filing to go public, with an S-1 submitted to the U.S. SEC on July 17. The company joins 15 others that have completed IPOs in 2025 and one other in process – Carlsmed Inc., which a company spokesperson told BioWorld is expected to...
  • Handshake, money, calculator, MA-letters

    Med-tech M&A value drops to $12M in June after strong Q2

    Analysis and data insight
    Med-tech publicly disclosed deal value reached just $5 million in June 2025, capping a weak quarter for the sector. Total deal value for the first half of the year came to just $320.14 million, with no single month crossing the $200 million mark.
  • Lumos’ Febridx rapid POC test

    Lumos stock rockets 162% on commercialization deal worth $317M

    Infection
    Lumos Diagnostics Inc.’s stock shot up 162% Wednesday morning on news that it signed a pivotal commercial deal with Phase Scientific International Ltd to expand its reach into the U.S. market for its Febridx rapid, point-of-care test for bacterial infections.
  • Going public ticker

    Carlsmed aims for $100M+ IPO

    Financings
    Carlsmed Inc. launched its IPO at a price of $14 to $16 per share for 6.7 million shares, which would raise just over $100.5 million at the midpoint. The spinal surgery technology company could well pull in more money, if recent history provides guidance. Most med-tech IPOs this year have settled...
  • Merger-arrows-black-white.png

    BD’s biosciences & diagnostics unit in $17.5B merger with Waters

    Merger
    Three months earlier than an expected update on a deal, Becton, Dickinson and Co. reported its biosciences and diagnostic solutions business will combine with Waters Corp. in a transaction valued at $17.5 billion. The resulting enterprise will operate under the Waters name and use its trading...
More in Deals and M&A

U.S.

  • Trump administration’s AI action draws props from med tech

  • Boston Sci posts 117% U.S. PFA growth, halves tariff impact

  • US organ donation system in crisis as Congress, HHS weigh in

  • Plexāā Bloom43 to transform breast reconstruction surgery

  • Globus CEO leaving, analysts see replacement as steady hand

  • Abbott med tech bumps up Q2 results

  • Uromems gets OK for Uroactive stress urinary incontinence trial

  • Impulse Dynamics inches closer to Medicare coverage for CCM

  • Med tech helps boost J&J to strong 2Q beat

  • Caranx Medical gets FDA nod for TAVR software Tavipilot Soft

Europe

  • Gears with regulatory words

    MDCG guidance highlights hazards of modifications in IVD studies

    EMA
    New guidance by the Medical Device Coordination Group spells out many of the routine aspects of compliance with the In Vitro Diagnostic Regulation, but test developers should remain aware of the tripwires in connection with modifications to both the test and the test’s performance studies.
  • Directsens partners with Metage to validate test for early type 2 diabetes

    Diabetes
  • Life sciences strategy to reduce UK approval costs by 25%

    Regulatory
  • UK Biobank project complete, supports research with 100,000 scans

    Science
  • NICE endorses pulsed field ablation for atrial fibrillation

    Regulatory
More in Europe

Asia-Pacific

  • DeepQure

    Deepqure expands renal denervation trial to atrial fibrillation

    Clinical
    Deepqure Inc. gained clinical trial clearance from South Korea’s Ministry of Food and Drug Safety to test its Hyperqure renal denervation system for the treatment of atrial fibrillation.
  • 34 mainland China biotechs file for Hong Kong IPO in H1 2025

    Analysis and data insight
    Thirty-six biotechnology, pharmaceutical and medical device companies sought a capital raise on the Hong Kong Stock Exchange in the first half (H1) of 2025, a review by BioWorld found. Of those, 34 companies were from mainland China.
  • FDA green lights Cochlear’s smart cochlear implant

    Regulatory
    Cochlear Ltd. heard good news from the U.S. FDA, as the agency approved its next-generation cochlear implant, the Nucleus Nexa System, the first smart cochlear implant system. Cochlear expects to launch the new products in the U.S. in the next few months, Brendan Murray, vice president for Cochlear...
  • UDI mandates kick in for devices in Australia

    Regulatory
  • Med-tech IPOs gain steam going into Q3

    Deals and M&A
  • Tetratherix lists on ASX in $25M IPO

    Financings
  • Multiple multianalyte sensors for diabetes on horizon

    American Diabetes Association
More in Asia-Pacific

Clinical

  • Serac Imaging sees clinical value of gamma imaging camera

    Cancer
    Serac Imaging Systems Ltd. reported encouraging data from two clinical trials demonstrating the effectiveness of its Seracam portable hybrid gamma-optical camera as a point-of-care imaging solution. The studies show the camera’s value in nuclear...
  • Nuclidium’s radiopharma approach draws $99M in series B

    Financings
    Nuclidium AG is poised to circumvent the complex production and supply issues that have held back access to radiopharmaceuticals after closing a CHF79 million (US$99.3 million) series B, to advance the clinical development of its copper isotopes...
  • Glucomodicum reports positive data from its needle-free CGM

    Diabetes
    Glucomodicum Oy reported positive results from a clinical study in which its needle-free continuous glucose monitor, Talisman, was tested in participants across both standard multi-hour glucose tolerance and ambulatory conditions involving...
  • UK industry encourages renewal of rare disease framework

    Science
    Representatives of patients’ groups, industry bodies and venture philanthropy funders are calling for a renewal of the U.K. Rare Diseases Framework, to put fresh momentum behind translational research and clinical trials, streamline regulatory...
  • Accunea’s Renosure device can save kidneys from being discarded

    Urology
    Accunea Ltd.’s bioanalysis technology, Renosure, can measure creatinine clearance in machine perfused kidneys, according to data presented at the recent European Society of Organ Transplantation 2025.
  • In-patient BYOD still troublesome for CGM makers

    American Diabetes Association
    With a growing number of people wearing continuous glucose monitors and an ever-shrinking number of hospital-based nurses, bringing your own device or using personal CGMs to measure glucose levels during hospitalizations seems like a no-brainer.
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:

  • 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
  • Gene and cell therapies will propel innovation, says Astellas CCO
  • Capricor’s CEO pursues a BLA and talks rare disease
  • The first half of 2024 was strong as M&As and financings dominate

View all

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