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.
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.
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.
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 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 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.
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.
Robert 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.
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 Inc. reported a new collaboration with Microsoft Corp. July 2 to jointly develop medical AI programs accessible on Microsoft’s Azure cloud platform.
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.
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.
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.
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).
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 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.
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 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 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 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...
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...
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.
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.
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.
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...
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 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 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...
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 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.
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.
Breakthrough 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.