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BioWorld MedTech

Sun, Jun 22, 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: Trump administration impacts continue to roil the life sciences sector
  • Businessman and IPO virtual screen

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

    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, then raised it to $19 to $20, before closing on a price of $21 per share. As management rang the bell for the start of trade on June 18, shares began trading at $28.
  • Deski raises $6M for Heartfocus cardiac imaging software

    Deski SAS raised $6 million in a seed round to support the launch of its cardiac imaging software, Heartfocus, in the U.S. The AI-driven heart exam tool helps health care professionals perform echocardiograms from any ultrasound probe to enable the early detection of heart disease.
  • Caris settles IPO at $21, trading starts at $28

    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, then raised it to $19 to $20, before closing on a price of $21 per share. As management rang the bell for the start of trade on June 18, shares began trading at $28.
  • Deski raises $6M for Heartfocus cardiac imaging software

    Deski SAS raised $6 million in a seed round to support the launch of its cardiac imaging software, Heartfocus, in the U.S. The AI-driven heart exam tool helps health care professionals perform echocardiograms from any ultrasound probe to enable the early detection of heart disease.
  • FDA scrutinizing trials sending US patient cells to China

    Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
  • EACR 2025: A look into next-generation strategies in cancer

    At the Annual Congress of the European Association for Cancer Research (EACR) in Lisbon, multiple sessions aimed to provide fresh perspectives on the always challenging treatment of cancer, with a strong focus on innovative strategies.
  • Makary lays out FDA’s path, launches pilot review program

    On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
  • Holiday notice

    BioWorld's offices will be closed in observance of Juneteenth in the U.S. No issue will be published Thursday, June 19.
  • Today's news in brief

    BioWorld MedTech briefs for June 18, 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

  • 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...
  • 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...
More in Digital health

Today's news in brief

  • Appointments and advancements June 20, 2025

  • Financings for June 20, 2025

  • In the clinic for June 18, 2025

  • Other news to note for June 20, 2025

  • Regulatory actions for June 20, 2025

Regulatory

  • Rising demand spurs Neurent to open new Neuromark facility

  • Too much at stake for dismissed ACIP members to go quietly

  • US universities developing alternative to cover indirect costs

  • Inquis, Penumbra advance thrombectomy treatments

  • CMS agrees to cover at-home ventilation for chronic respiratory failure

  • FDA releases another batch of regs for de novo decisions

  • Advamed presses CMS to require MA plans to honor NTAP program

  • MHRA advises industry that new requirements are now in place

  • Federal judge reinstates funding for NIH DEI grants

  • FDA approves Medtronic Omniasecure defib lead

Financings

  • Aortyx catheter

    Aortyx secures €13.8M for aortic dissection solution

    Cardiovascular
    Aortyx SL secured €13.8 million (US$15.9 million) in a series A funding round for its solution which treats aortic dissection. The company developed a system to repair the aortic tear, which includes a biomimetic, bioresorbable adhesive patch inserted in the aorta using an endovascular catheter and...
  • Wandercraft secures $75M in series D funds for robotics portfolio

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

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

    Regulatory
  • May med-tech financings surged to $3.51B

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

  • 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.
  • Merger-puzzle-pieces-arrow-hands.png

    Antylia’s $1.34B deal tops cooling med-tech M&A activity in May

    Med-tech M&A activity dipped in May, reaching $1.52 billion, down from $2.07 billion in April and a far cry from the highs seen earlier this year, such as $4.92 billion in January and $5.99 billion in February.
  • 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.
  • EU flag and light bulb

    EU launches new strategy supporting growth of innovative startups

    Analysis and data insight
    The EU is having another go at improving access to capital for biotechs and science-based startups, in a bid to enable them to remain anchored in Europe. The Startup and Scaleup strategy, announced on May 28, is a response to the long-running problem that although Europe has strong foundations in...
More in Deals and M&A

U.S.

  • What's the secret behind Boston Sci's successful product launches?

  • The Ps and Qs of challenging a market leader

  • Researchers file patent for microfluidic patch-pump drug delivery platform

  • 23andme genetic privacy concerns garner Congressional scrutiny

  • IVL innovators: How to challenge a market leader

  • Diabetes partnerships abound ahead of ADA

  • Livanova petitions CMS for VNS therapy coverage reconsideration of TRD

  • Vaccines meeting to go on in wake of ACIP demolition

  • Canceling claims not an appropriate sanction, USPTO says

  • FDA rapidly lists raft of class I device recalls

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

    Regulatory
  • Aiatella secures €2M for AI-based cardiovascular imaging tech

    Financings
More in Europe

Asia-Pacific

  • Doctor with illustration of kidneys

    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.
  • TGA files court action against Philips over CPAP foam controversy

    Regulatory
    Australia’s Therapeutic Goods Administration initiated court proceedings against Philips Electronics Australia Ltd. over sound abatement foam used in CPAP machines marketed under the Respironics brand.
  • 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.
  • 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
  • Singapore’s Quadria Capital closes $1B health care-focused fund

    Financings
  • EBR Systems raises $36M to sell Wise CRT therapy

    Financings
More in Asia-Pacific

Clinical

  • Menstrual blood-based device detects disease biomarkers

    Women's health
    Researchers at ETH Zürich developed Menstruai, a device that detects in menstruation blood biomarkers associated with certain diseases. Menstruai uses a sensor built into a sanitary pad and changes color if certain biomarkers are present. The...
  • Paradromics joins BCI in-human race

    Neurology/psychiatric
    Paradromics Inc. became the latest company developing a brain-computer interface (BCI) system to implant its technology, Connexus, into a human. The device was safely implanted, it recorded electrical brain signals and was removed intact in less...
  • 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...
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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