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BioWorld MedTech

Tue, Jul 08, 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
  • insightec-exablate-neuro-12-13.png

    Insightec gains FDA approval for Exablate Neuro use in Parkinson’s

    Insightec Ltd. received U.S. FDA approval for use of its Exablate Neuro device to address severe motor symptoms in patients with Parkinson’s disease, offering a new option for patients who have not found adequate relief from medications. Exablate Neuro uses focused ultrasound to create lesions in the brain without requiring an incision or implant.
  • Iancu: Patent reform undone by multinationals’ apathy over IP rights

    Patent reform in the U.S. revolves largely around the subject matter eligibility question, but Congress is reluctant to intervene – a predicament addressed recently by Andrei Iancu, formerly the director of the U.S. Patent and Trademark Office.
  • Insightec gains FDA approval for Exablate Neuro use in Parkinson’s

    Insightec Ltd. received U.S. FDA approval for use of its Exablate Neuro device to address severe motor symptoms in patients with Parkinson’s disease, offering a new option for patients who have not found adequate relief from medications. Exablate Neuro uses focused ultrasound to create lesions in the brain without requiring an incision or implant.
  • Iancu: Patent reform undone by multinationals’ apathy over IP rights

    Patent reform in the U.S. revolves largely around the subject matter eligibility question, but Congress is reluctant to intervene – a predicament addressed recently by Andrei Iancu, formerly the director of the U.S. Patent and Trademark Office.
  • Glucomodicum reports positive data from its needle-free CGM

    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 exercise and meals.
  • CMS formally proposes to terminate ESRD choices program

    The U.S. Centers for Medicare & Medicaid Services indicated it will act on a previous proposal to terminate the Treatment Choices Model for ESRD at the end of the current calendar year because of a failure of the program to deliver on the promised efficiencies and improvement in outcomes.
  • UK industry encourages renewal of rare disease framework

    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 oversight and improve access to therapies.
  • More than $16B in med-tech funding raised through 1H25

    The med-tech sector raised $16.46 billion in the first half of 2025, an 18% increase over the $13.94 billion raised during the same period in 2024.
  • Today's news in brief

    BioWorld MedTech briefs for July 8, 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

  • 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.
  • Businessman and IPO virtual screen

    Hinge Health rings NYSE bell as IPO raises $437M

    Orthopedics
    Hinge Health Inc.’s flexibility produced big rewards as the digital therapy company for physical rehabilitation finally began trading on the NYSE under the symbol HNGE on May 22 after delaying its IPO twice. Hinge co-founders Daniel Perez and Gabriel Mecklenburg rang the opening bell for the stock...
More in Digital health

Today's news in brief

  • Appointments and advancements July 8, 2025

  • Financings for July 8, 2025

  • In the clinic for July 8, 2025

  • Other news to note for July 8, 2025

  • Regulatory actions for July 8, 2025

Regulatory

  • FDA greenlights Boston Sci’s Farapulse for persistent AF

  • UDI mandates kick in for devices in Australia

  • Court order holds HHS to the law when removing online data

  • EU unveils new ‘Choose Europe for life sciences’ strategy

  • CMS deletes two specialists to NCD final for tricuspid repair devices

  • Industry could feel fallout of Pfizer vaccine scrutiny

  • New US working group to step up FCA enforcement

  • House passes H.R. 1, restoring R&D tax cuts

  • MDCG guidance document resurrects issue of standards for AI

  • Medtronic receives CE mark for its Vitalflow ECMO system

Financings

  • Single Shot PVI

    Kardium beats expectations with $250M haul

    Cardiovascular
    Kardium Inc. raised C$340 million (US$250 million) in an oversubscribed financing round to support commercialization of its Globe pulsed field ablation system for atrial fibrillation. Notably, the financing included an equity investment by an unnamed leading strategic investor. Kardium could...
  • Tetratherix lists on ASX in $25M IPO

    Dental
  • Forsight Robotics secures $125M for eye surgery robotics platform

    Ophthalmic
  • Polyactiva raises $25M series C to advance U.S. clinical programs

    Ophthalmic
  • Deski raises $6M for Heartfocus cardiac imaging software

    Cardiovascular
More in Financings

Newco news

  • 3D illustration of a chain of amino acid or biomolecules called protein

    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
    Health care technology company Wearoptimo Ltd. developed a next-generation microwearable sensor that accurately detects hydration levels, outperforming the needle-based gold standard.
  • 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
  • Researchers develop visual prosthetic to restore sight

    Neurology/psychiatric
More in Newco news

Deals and M&A

  • Wall Street sign

    Med-tech IPOs gain steam going into Q3

    IPO
    The IPO market for med-tech companies continues to set new records. With one IPO closed the last week of June, two slated for the first week of July and another pending, 2025 will shortly exceed the total number of IPOs closed in the previous two years combined as well as the number completed in 2022.
  • Blood glucose chart and monitor, stethoscope, injector pen

    Two new options presented at ADA for early diagnosis of T1D

    American Diabetes Association
    Classically, the diagnosis of type 1 diabetes comes after a patient presents with unexplained weight loss, extreme thirst and frequent urination and a lab test reveals off-the-charts blood glucose levels. At the 85th Scientific Sessions of the American Diabetes Association in Chicago, researchers...
  • Scientists shaking hands in the lab

    Illumina buying Somalogic for up to $425M to boost multiomics assets

    Acquisition
    In a bid to boost its multiomics holdings, Illumina Inc. reported an agreement to buy proteomics technology company Somalogic Inc. from Standard Biotools Inc. for $350 million in cash, plus up to $75 million in near-term performance-based milestones and performance-based royalties.
  • Businessman and IPO virtual screen

    Caris settles IPO at $21, trading starts at $28

    Cancer
    Despite raising the price of its IPO twice, Caris Life Sciences Inc. left money on the table with a 33% increase in price as soon as trading commenced on the Nasdaq, though no one is squawking about raising nearly $500 million. The cancer diagnostics company initially priced its IPO at $16 to $18,...
  • Telomeres and DNA illustration

    23andme founder-led group outbids Regeneron for company

    Acquisition
    The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against Regeneron Pharmaceuticals Inc.
More in Deals and M&A

U.S.

  • Massive budget reconciliation bill restores deductibility of R&D expenses

  • Field reaps $35M for ventricular PFA

  • OIG presses CMS to act on overpayments related to global episodes

  • CMS eyes competitive bidding for CGMs, insulin pumps

  • New York Valves: More options, more valves

  • US agencies to assemble health care fraud data fusion system

  • Another court orders halt to US HHS reorganization

  • Tissium’s polymer solution set to transform nerve repair after FDA nod

  • FDA retains non-statutory definition of cyber device in final guidance

  • NICE still wary of TAVR in moderate and low risk patients

Europe

  • Accunea monitoring device

    Accunea’s Renosure device can save kidneys from being discarded

    Clinical
    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.
  • Technologies core to UK NHS 10-year plan

    Artificial intelligence
  • Anaconda Biomed funnel catheter gets EU nod for ischemic stroke

    Regulatory
  • UK’s MHRA first regulatory to join Health AI’s global regulator network

    Regulatory
  • Headwinds abound for NHS transformation

More in Europe

Asia-Pacific

  • Abbott sign

    Multiple multianalyte sensors for diabetes on horizon

    American Diabetes Association
    Abbott Laboratories grabbed attention in early June with its announcement of a partnership with Tandem Diabetes Care Inc. to develop a multianalyte sensor for people with diabetes that would measure ketones as well as glucose.
  • MFDS clears world’s first ECG-based AI kidney disease software

    Regulatory
    South Korea’s Ministry of Food and Drug Safety on June 9 approved Vuno Inc’s AI-based Med-DeepECG Kidney software as a non-invasive method to screen for kidney dysfunction.
  • European Commission clamps down on Chinese med tech

    Europe
    The trade wars spanning the globe lined up some unlikely-seeming adversaries, and such is the case in the trade scrum between the EU and China.
  • TGA files court action against Philips over CPAP foam controversy

    Regulatory
  • Microneedles could solve vaccine distribution challenges

    Drug design, drug delivery and technologies
  • Korea pharma exports rise to quarterly high of $2.5B in Q1

    Analysis and data insight
  • Alexandra Hospital team patents new AI robotic knee surgery

    Artificial intelligence
More in Asia-Pacific

Clinical

  • 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.
  • UK Women to be offered home-testing kits for cervical screening

    Cancer
    The U.K. government will offer women home-testing kits for cervical screening as part of an effort to tackle barriers and get more of them taking this potentially life-saving test.
  • AID system improves glycemic control in pregnancy

    Diabetes
    Pregnant women with type 1 diabetes who used a hybrid closed loop automated insulin delivery system averaged more than three additional hours per day in their recommended glucose range than those who managed their diabetes with insulin injections...
  • Fractyl pursues dual track to cure T2 diabetes

    American Diabetes Association
    At the American Diabetes Association 85th Scientific Sessions in Chicago June 20-23, Fractyl Health Inc. presented results from two studies evaluating very different approaches to treating – and possibly curing – type 2 diabetes.
  • Fineheart pursues FIH study of Flowmaker fully implanted heart pump

    Cardiovascular
    Fineheart SA will soon begin a first-in-human study of Flowmaker, its fully implantable left ventricular assist device, in France, after receiving authorization from the French National Agency for the Safety of Medicines and Health Products to...
  • Newel Health secures CE mark under MDR for BP app

    Europe
    Newel Health srl received CE mark certification under the European Medical Device Regulation for Amicomed, its digital therapeutic solution for hypertension management. The app, which was cleared as a class IIa medical device, provides clinical...
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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