FDA greenlights Medtronic Onyx subdural hematoma treatment
Sometimes the darkest products (names) bring a bright spot of news to their developers, as the U.S. FDA clearance for Galway, Ireland-based Medtronic plc's Onyx liquid embolic system demonstrates. Onyx gained the indication for embolization of the middle meningeal artery as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma based on the EMBOLISE trial results. The approval represents a significant advancement in treating this common neurosurgical condition.

Ebenbuild aims to transform lung care with digital twin tech
Ebenbuild GmbH is hoping that its digital twin technology platform that combines AI and physics-based computational models tailored to individual patients will transform respiratory care. From drug development to optimizing mechanical ventilation in critical care, the company’s software-based solutions aim to reveal what is happening in the ‘black box’ of the lungs, helping clinicians to improve outcomes and reduce mortality.

FDA greenlights Medtronic Onyx subdural hematoma treatment
Sometimes the darkest products (names) bring a bright spot of news to their developers, as the U.S. FDA clearance for Galway, Ireland-based Medtronic plc's Onyx liquid embolic system demonstrates. Onyx gained the indication for embolization of the middle meningeal artery as an adjunct to surgery for the treatment of symptomatic subacute or chronic subdural hematoma based on the EMBOLISE trial results. The approval represents a significant advancement in treating this common neurosurgical condition.
Ebenbuild aims to transform lung care with digital twin tech
Ebenbuild GmbH is hoping that its digital twin technology platform that combines AI and physics-based computational models tailored to individual patients will transform respiratory care. From drug development to optimizing mechanical ventilation in critical care, the company’s software-based solutions aim to reveal what is happening in the ‘black box’ of the lungs, helping clinicians to improve outcomes and reduce mortality.
November reignites med-tech momentum with $4.7B raised
Med-tech financing activity from January through November 2025 reached $31.32 billion, marking a strong rebound from the sector’s lows in 2023 to 2024, which saw $16.61 billion and $23.64 billion in the same period, respectively. While still far below the capital inflows seen in 2020 and 2021, when the first 11 months of the year exceeded $48 billion, the steady upward progression over recent years suggests renewed investor engagement and improving capital availability. In November, $4.73 billion was collected through 36 transactions, up from $3.25 billion in October.
Optimized organoid model gives insights into celiac disease
Investigators at the Netherlands Hubrecht Institute have developed a novel gut organoid model, and used it to gain insight into the functions on human microfold (M) cells. Their experiments, which were published in the Dec. 10, 2025, issue of Nature, showed that M cells present gluten-derived antigens to T cells, which suggests a role for this cell type in the onset of celiac disease.
The BioWorld Insider podcast: Finding a better, longer-lasting fix in opioid overdose
The opioid crisis may not be front and center anymore, but it’s raging still. A major problem is that overdose-reversal drugs don’t last long enough to help users who opt out of hospital treatment after they are revived. Elysium Therapeutics Inc. CEO Greg Sturmer talks with Randy Osborne about his firm’s candidate for a solution to the medical and societal problem.
Today's news in brief
BioWorld MedTech briefs for Dec. 12, 2025.

BioWorld Insider podcast

The opioid crisis may not be front and center anymore, but it’s raging still. Elysium Therapeutics Inc. CEO Greg Sturmer talks about his firm’s candidate for a solution to the medical and societal problem.

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Digital health

Cha Group to Acquire Majority Stake in Kakao Healthcare
Deals and M&A
Kakao Healthcare Corp. plans to secure ₩100 billion (US$68 million) through two investment deals with Cha Biomedical Group and outside investors by early next year. The transactions, expected to close by the first quarter of 2026, will make Cha the controlling shareholder of Kakao Healthcare with a...
Minze, Medtronic partner on overactive bladder care in EMEA
Urology
Minze Health NV signed a three-year agreement with Medtronic plc to bring its Minze Diary Pod, an app-controlled automated urine collection device, to markets across the EMEA region. The partnership aims to enhance the support services available for patients with overactive bladder receiving sacral...
South Korea ramping up investment in medical device R&D
Regulatory
A four-way interagency initiative in South Korea, started in 2020, is working to bolster funding for the local medical device industry and grow homegrown devices for the global market.
SK Bio, Eurofarma launch Mentis Care for digital epilepsy care
Newco news
SK Biopharmaceuticals Co. Ltd. and Eurofarma Laboratórios SA launched a new joint venture (JV) called Mentis Care Inc. Oct. 21, dedicated to developing an AI-powered platform for epilepsy management.

Financings

73 Chinese biotech, med-tech companies file for HK IPOs in 2025
Analysis and data insight
Seventy-three pharmaceutical, biotechnology and medical device companies from mainland China filed for IPOs in Hong Kong this year, a review by BioWorld found. In the second half of 2025, 43 new securities reports were filed on the Hong Kong Stock Exchange, increasing from the 30 applications in...

Newco news

Levron emerges with cardio-respiratory physiology assist tech
Clinical
Levron Medical Ltd. recently exited stealth mode to advance its cardio-respiratory physiology assist technology, designed to treat heart failure by synchronizing the heart and lungs. The approach harnesses the natural ‘respiratory pump’ to assist cardiac function and create what the company claims...

Tulyp emerges from stealth with pressure-driven perfusion system
Clinical
Tulyp Medical Inc. has emerged from stealth mode with a pressure-driven perfusion system designed to improve vascular procedures. The company, born out of Sofinnova Partners' medical device accelerator, has submitted the technology to the U.S. FDA for 510(k) clearance following initial clinical...
Symbyx light therapy shows sustained benefits in Parkinson’s
Gastrointestinal
The largest study ever conducted on light therapy for Parkinson’s disease has found that long-term use of Symbyx Biome Pty Ltd.’s non-invasive, at-home photobiomodulation (PBM) devices significantly improved mobility, anxiety, and overall symptom severity.

Deals and M&A

Alcon sweetens offer for Staar, major shareholders still unimpressed
Implantable ocular lenses
Alcon AG reported on Dec. 9 that it had sweetened its offer for intraocular lens maker Staar Surgical Co., raising its offer by roughly 10% to $30.75 a share from its prior bid of $28 a share. The revised offer comes on the heels of the expiration of Staar’s go-shop period on Dec. 8, in which Lake...
Teleflex selling 3 business units for $2.03B
Cardiovascular
Teleflex Inc. reported plans to sell its Acute Care, Interventional Urology and OEM businesses to two buyers for $2.03 billion. Intersurgical Ltd. will acquire the Acute Care and Interventional Urology units for $530 million. Additionally, private equity firms Montagu and Kohlberg are buying its...
Natera envisions cancer-testing future with $450M Foresight buy
Cancer
Natera Inc. completed the acquisition of Foresight Diagnostics Inc. in a deal structured as $275 million up front plus contingent payments of up to $175 million based on achieving certain milestones for revenue and reimbursement coverage. The companies expect to close the transaction in the second...
Med-tech deals rebound with a $1.37B surge in Q3
Med-tech dealmaking totaled $1.72 billion through the first three quarters of 2025, signaling a potential rebound in the works from the subdued activity seen in 2024, when publicly reported full-year deal value reached $2.12 billion. Q3 was the strongest quarter so far this year, contributing $1.37...
GE Healthcare expands imaging line with $2.3B Intelerad buy
Imaging
GE Healthcare Technologies Inc. agreed to purchase medical imaging company Intelerad Medical Systems Inc. for $2.3 billion in cash, boosting its capabilities in cardiology and radiology. The deal, expected to close in the first half of 2026, advances GE Healthcare's dual strategies of expanding...

Europe

New recombinant strain of mpox virus identified in the UK
Science
The UK Health Security Agency (UKHSA) has identified a new recombinant strain of mpox (formerly monkeypox) that contains elements of clade Ib and clade IIb of the virus, in a traveler who recently returned from Asia. In a paper describing the new strain, the researchers at UKHSA say it is not...

Asia-Pacific

Diag-nose.io develops respiratory disease precision diagnostics
Respiratory
A precision medicine diagnostic system developed by Diag-Nose Medical Pty. Ltd. could potentially transform the management of chronic respiratory diseases. Co-founders Eldin Rostrom, David Yen, Brian Wang and Josie Xu set out to explore why patients with similar respiratory symptoms respond so...

China’s Cornerstone Robotics raises $200M series D round
Financings
Cornerstone Robotics Ltd. raised an oversubscribed $200 million series D round to accelerate commercialization of its flagship product, the Sentire Endoscopic Surgical System.
TGA updates ad guidelines to include social media
Regulatory
Australia’s Therapeutic Goods Administration has made a few adjustments to its advertising guidelines for social media promotions, including the requirement that the manufacturer is responsible for anything posted by influencers who are acting on behalf of the manufacturer.

Clinical

Fractyl procedure sustains weight loss after GLP-1s
Diabetes
Glucagon-like peptide-1 (GLP-1) receptor agonists clearly help patients shed pounds, but many regain all - or more - of the weight once they discontinue the medications. Fractyl Health Inc. could offer an enduring solution with its Revita...
Xeltis secures $55M for vascular access conduit
Cardiovascular
Xeltis BV secured €47.5 million in financing to help bring Axess, its vascular access conduit for hemodialysis, to the market. The funds include a venture debt package of up to €37.5 million from the European Investment Bank and €10 million from...
Edwards shows benefits of early TAVR in asymptomatic severe AS
Cardiovascular
Edwards Lifesciences Corp. released data from a health economics study done across nine countries in Europe which showed that early transcatheter aortic valve replacement in patients with asymptomatic severe aortic stenosis can deliver significant...
Could restricting diversity efforts stall women’s health research?
Conferences
Recent progress in redressing the historical underfunding and neglect of women’s health could be undermined by the backlash against diversity, equity and inclusion (DEI) initiatives, according to executives participating in the FT Global Pharma...
Archeon’s Eolife increases survival rates after cardiac arrest
Cardiovascular
Archeon Medical SAS reported data from a study showing its real-time ventilation feedback device Eolife increased the survival rates of patients suffering out‑of‑hospital cardiac arrests. Furthermore, all the survivors in the Eolife group achieved...
Ocean Dx sepsis test matches gold standard in early study
Infection
A rapid diagnostic test from Ocean Dx SAS delivered gold standard performance in a clinical evaluation that points to a potential shift in how sepsis is identified and treated. The assay, which detects more than 1,000 bacterial species directly...

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