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BioWorld - Friday, June 13, 2025
Breaking News: After iffy adcom, FDA clears Urogen’s Zusduri mitomycin Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
  • Atalante X Wandercraft

    Wandercraft secures $75M in series D funds for robotics portfolio

    Wandercraft SAS secured $75 million in funding in a series D round to grow its AI-powered robotics solutions. Funds will be spent on its exoskeletons, Atalante X and Eve, as well as on the industrial development and rollout of Calvin 40, its humanoid robot.
    • Wandercraft secures $75M in series D funds for robotics portfolio

      Wandercraft SAS secured $75 million in funding in a series D round to grow its AI-powered robotics solutions. Funds will be spent on its exoskeletons, Atalante X and Eve, as well as on the industrial development and rollout of Calvin 40, its humanoid robot.
    • What's the secret behind Boston Sci's successful product launches?

      Boston Scientific Corp.’s Farapulse pulsed field ablation system racked up more than $1 billion in revenue in its first year; its Watchman left atrial appendage occluder holds more than 90% of the market. How does the company choose and position its products for such astonishing success?
    • The Ps and Qs of challenging a market leader

      Med-tech veterans advised companies looking to launch new products in fields with dominant players to mind their 'Ps and Qs,' but not the ones your mother drilled in childhood. Rather than good manners, they urged competitors attending Device Talks Minnesota to ensure they had the right people, product, proof, pace and quality control.
    • Researchers file patent for microfluidic patch-pump drug delivery platform

      Researchers from Virginia Polytechnic Institute and State University filed for protection of their development of a slim, painless, and affordable microfluidic infusion pump device for the continuous transdermal delivery of drugs.
    • Today's news in brief

      BioWorld MedTech briefs for June 12, 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

    • 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...
    • Kakao Pasta app

      Kakao Healthcare brings CGM app to Japan

      Diabetes
      Step aside, Marco Polo: Kakao Healthcare Corp. plans to bring PASTA to Japan. PASTA is Kakao's AI-based continuous glucose monitoring (CGM) management mobile application, which will be available in Japan through a new subsidiary as the health care company works to expand its global presence.  
    • urine testing device

      Urine-testing device turns toilets into health trackers

      Diabetes
      In what represents just the company’s third PCT filing, Houston-based Starling Medical Inc.’s co-founders, Hannah McKenney and William Hendricks, seek to gain further protection for their at-home urine diagnostic patient-monitoring platform that eliminates the traditional use of catching containers...
    • Ribbons of digital data

      Survey says AI must overcome trust issue to transform health care

      Artificial intelligence
      Royal Philips NV unveiled its Future Health Index report for 2025, and it reveals the widening trust gap between health care professionals and patients concerning the adoption of AI in health care.
    More in Digital health

    Today's news in brief

    • Appointments and advancements June 12, 2025

    • Financings for June 11, 2025

    • In the clinic for June 12, 2025

    • Other news to note for June 12, 2025

    • Regulatory actions for June 12, 2025

    Regulatory

    • NHS deploying Histosonics' Edison to slash health care red tape

    • MFDS clears world’s first ECG-based AI kidney disease software

    • Lex seeks FDA clearance ahead of $100M Quidelortho takeover

    • Livanova petitions CMS for VNS therapy coverage reconsideration of TRD

    • Vaccines meeting to go on in wake of ACIP demolition

    • TGA files court action against Philips over CPAP foam controversy

    • Medical AI left out of EU’s proposal to relax high-risk AI mandates

    • Canceling claims not an appropriate sanction, USPTO says

    • FDA rapidly lists raft of class I device recalls

    • FDA’s device center playing guidance catch-up

    Financings

    • Green, blue, gray dollar signs

      May med-tech financings surged to $3.51B

      The med-tech industry brought in $13.74 billion from January through May 2025, up from $12.76 billion during the same period last year. In May alone, the sector raised $3.51 billion across 47 transactions, nearly doubling April’s total value of $1.88 billion from 37 deals.
    • Aiatella secures €2M for AI-based cardiovascular imaging tech

      Artificial intelligence
    • Allay’s $57.5M extends postsurgical pain relief with ATX-101

      Neurology/psychiatric
    • Singapore’s Quadria Capital closes $1B health care-focused fund

      Asia-Pacific
    • EU launches new strategy supporting growth of innovative startups

      Analysis and data insight
    More in Financings

    Newco news

    • Zip p2 platform

      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
      Researchers from the University of Cincinnati filed for protection of an electrochemical aptamer-based biosensor technology with improved sensitivity and longevity, which has the potential for monitoring several biomarkers over sustained periods.
    • 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
    • New Zealand’s Avasa develops world-first arterial coupler

      Cardiovascular
    More in Newco news

    Deals and M&A

    • The Nasdaq Stock Exchange headquarters in New York

      Omada, Caris arrivals continue med-tech IPO hot streak

      Cancer
      Omada Health Inc. rang the opening bell on the New York Stock Exchange on June 6, marking its first day as a public company, but it won’t be the most recent IPO for very long. Continuing the brisk pace seen so far this year, Caris Life Sciences Inc. is hot on its heels with a road show in progress...
    • White puzzle pieces on blue background

      Highridge sells bone healing business to Avista

      U.S.
      In the midst of June’s peak wedding season, Highridge Medical LLC called it splitsville – selling its bone healing division to Avista Healthcare Partners. The latest separation continues the sundering of what Zimmer Biomet Holdings Inc. so carefully joined together a decade ago.
    • Hands holding torn contract

      Medtronic aims to sweeten appeal by unloading diabetes unit

      Cardiovascular
      Medtronic plc revealed plans to spin off its underperforming diabetes unit as a separate public company during its fourth quarter 2025 earnings call May 21. The company expects to complete the separation within 18 months.
    • Medtronic aims to sweeten appeal by unloading Diabetes unit

      Europe
      Medtronic plc revealed plans to spin off its underperforming diabetes unit as a separate public company during its fourth quarter 2025 earnings call on May 21. The company expects to complete the separation within 18 months.
    • 23andme saliva collection kit

      Regeneron plans to buy 23andme from bankruptcy for $256M

      Regeneron Pharmaceuticals Inc. was the successful bidder for 23andme Holding Co.’s personal genome service, total health and research services business lines, including its biobank and associated assets, in the bankruptcy auction to sell 23andme's assets.
    More in Deals and M&A

    U.S.

    • 23andme genetic privacy concerns garner Congressional scrutiny

    • IVL innovators: How to challenge a market leader

    • Diabetes partnerships abound ahead of ADA

    • Paradromics joins BCI in-human race

    • Fractyl, Bariendo developing off-ramp for post-GLP-1 maintenance

    • Telemedicine at the root of false claims conviction for more than $1B

    • FTC active again in enforcement of contact lens rule

    • Vantive to invest $1B in digital kidney support therapies

    • Bivacor pumped by artificial heart’s breakthrough designation

    • White House budget proposal would cut FDA, slash NIH budgets

    Europe

    • Fineheart Flowmaker

      Fineheart pursues FIH study of Flowmaker fully implanted heart pump

      Clinical
      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 initiate the trial.
    • European Commission clamps down on Chinese med tech

      Asia-Pacific
    • Newel Health secures CE mark under MDR for BP app

      Clinical
    • Menstrual blood-based device detects disease biomarkers

      Clinical
    • Korea pharma exports rise to quarterly high of $2.5B in Q1

      Analysis and data insight
    More in Europe

    Asia-Pacific

    • Vaxxas HD-MAP administration

      Microneedles could solve vaccine distribution challenges

      Drug design, drug delivery and technologies
      Microneedle technology could help simplify vaccine delivery to better support global immunization efforts, and Australia is leading the way in this innovative technology.
    • Alexandra Hospital team patents new AI robotic knee surgery

      Artificial intelligence
      A research team led by consultant and orthopedic surgeon Glen Liau Zi Qiang from Alexandra Hospital in Singapore developed a new AI algorithm to improve the accuracy and efficiency of robotic total knee arthroplasty (rTKA) surgery.
    • EBR Systems raises $36M to sell Wise CRT therapy

      Financings
      EBR Systems Inc. raised AU$55.9 million (US$36 million) to commercialize its Wise cardiac resynchronization therapy system following U.S. FDA approval in April of the wireless, endocardial pacing system to stimulate the heart’s left ventricle.
    • FDA continues offensive against bogus device test results

      Regulatory
    • GC Genome plans $30M IPO to diversify genomic products, suppliers

      Financings
    • Phase Scientific raises $34M series A to advance urine-based diagnostics

      Financings
    • FDA shift from animal testing fuels organoid, organ-on-chip demand

      Regulatory
    More in Asia-Pacific

    Clinical

    • Amber Vcfix spinal system shows promising data

      Orthopedics
      Amber Implants BV reported no device-related adverse events were seen in any of the patients fitted with its Vcfix spinal system, which treats vertebral compression fractures, at one-year. Data from the first-in-human trial of the device also...
    • Rising obesity levels spur endoscopic sleeve uptick

      Obesity
      While GLP-1 receptor agonists continue to grab the headlines as a treatment option for obesity, another therapy, endoscopic sleeve gastroplasty (ESG), is seeing a steady rise in demand.
    • It’s time for more trust in AI, panel says

      Conferences
      Despite the advancement of AI and machine learning technologies and their incorporation into cancer treatment and drug development, a lack of trust and understanding of these new approaches is impeding care and treatment.
    • Redemption for Lyra as second phase III rhinosinusitis trial hits goal

      Inflammatory
      Shares of Lyra Therapeutics Inc. soared more than 310% on data from its second phase III trial testing drug-device candidate LYR-210 in patients with chronic rhinosinusitis, with results from the Enlighten 2 study showing statistical significance...
    • FDA greenlights Distalmotion’s Dexter for gallbladder removal

      Regulatory
      The U.S. FDA granted 510(k) clearance to Distalmotion SA's Dexter, its surgical robotic system, for use in cholecystectomy in adults. The greenlight from the regulatory body is the second nod Dexter has received following de novo clearance granted...
    • In TAVR setback, Boston Sci pulls plug on Acurate valves

      Cardiovascular
      Boston Scientific Corp. reported the latest setback in its transcatheter aortic valve replacement (TAVR) aspirations with the news that it is officially discontinuing worldwide sales of its Acurate neo2 and Acurate Prime systems
    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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