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.

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Digital health

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, 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 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 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.

Financings

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.

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.

Deals and M&A

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...
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 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.
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...
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...

Europe

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.

Asia-Pacific

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...

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.

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