Phraxis Endoforce receives FDA approval for anastomosis
The U.S. FDA approved Phraxis Inc.’s Endoforce Connector for endovascular venous anastomosis, which eliminates the need for surgical dissection for individuals undergoing hemodialysis for kidney failure. The device is designed to reduce tissue trauma and improve long-term graft performance.

Edwards' data shows benefits of early intervention in aortic stenosis
Edwards Lifesciences Corp. released new economic and clinical data on severe aortic stenosis (AS) demonstrating intervening in a patient with the disease before symptoms develop can reduce costs to the health care system by $36,000. Data also shows earlier intervention can also lead to fewer follow-ups and hospitalizations for heart failure, after treatment.

Phraxis Endoforce receives FDA approval for anastomosis
The U.S. FDA approved Phraxis Inc.’s Endoforce Connector for endovascular venous anastomosis, which eliminates the need for surgical dissection for individuals undergoing hemodialysis for kidney failure. The device is designed to reduce tissue trauma and improve long-term graft performance.
Edwards' data shows benefits of early intervention in aortic stenosis
Edwards Lifesciences Corp. released new economic and clinical data on severe aortic stenosis (AS) demonstrating intervening in a patient with the disease before symptoms develop can reduce costs to the health care system by $36,000. Data also shows earlier intervention can also lead to fewer follow-ups and hospitalizations for heart failure, after treatment.
PTO director candidate Squires appears at Senate Judiciary
The Trump administration nominated John Squires of the firm of Dilworth Paxson to take the post of director of the Patent and Trademark Office, but the appointment faces a few hurdles.
Seeme helps measure, detect consciousness after TBI
In what represents their first patenting, researchers from New York’s Stony Brook University filed for protection for development of a system and method that uses computer vision to analyze microscale facial movements in order to objectively help diagnose, monitor, and treat disorders of consciousness.
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Today's news in brief
BioWorld MedTech briefs for May 23, 2025.

Digital health

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 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 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...
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.

Financings

Phase Scientific raises $34M series A to advance urine-based diagnostics
Cancer
Phase Scientific International Ltd. raised $34 million in a series A round to accelerate research and development of its early disease detection technology for multiple cancers, women's health issues, and infectious diseases.

Newco news

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.

Deals and M&A

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.
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.
Med-tech M&A value rebounds in April with $1.4B
Med-tech M&A activity rebounded in April, reaching $1.4 billion, a sharp increase from March’s $22.63 million, though still down from nearly $5 billion in January and $6 billion in February.
Sounds of relief as Masimo unloads audio division
U.S.
News of the sale of Masimo Corp.’s consumer audio unit may be music to the ears of investors, even at the steep discount from its original purchase price. Samsung Electronics Co. Ltd.’s Harman International Industries Inc. unit snapped up the Sound United business for about $350 million – roughly...

Europe

Tricares Topaz valve significantly reduces tricuspid regurgitation
Clinical
Data from the first-in-human study of Tricares SAS Topaz transcatheter tricuspid valve replacement (TTVR) system, showed it significantly reduced tricuspid regurgitation (TR) in patients treated with the device. The early clinical data at 30 days demonstrated that all patients implanted with Topaz...

Asia-Pacific

FDA shift from animal testing fuels organoid, organ-on-chip demand
Regulatory
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said.

Cynata’s MSC cells show positive results across variety of delivery systems
Clinical
The promise of mesenchymal stem cells (MSCs) to heal heart disease could be around the corner thanks to a new delivery method tested by regenerative medicine company Cynata Therapeutics Ltd.
Oncosil’s brachytherapy device outperforms SBRT in pancreatic cancer
Clinical
Oncosil Medical Ltd.’s brachytherapy device outperformed stereotactic body radiation therapy plus chemotherapy in patients with unresectable or borderline-resectable locally advanced pancreatic cancer, according to a comparative analysis.

Clinical

Sonomind’s TUS device reduces depressive symptoms
Neurology/psychiatric
A low-intensity transcranial ultrasound stimulation device, developed by Sonomind SAS, was proven to be safe and effective in treating patients suffering from drug-resistant depression. The results of a study published in Brain Stimulation showed...
PFA continues to set EP hearts aflutter
Cardiovascular
Pulsed field ablation dominated discussions and scientific sessions at Heart Rhythm 2025 in San Diego with researchers and manufacturers touting new applications in persistent atrial fibrillation, atrial flutter and addressing specific challenges...
HRA/ACC release same-day discharge guidance for cardiac ablation
Cardiovascular
The Heart Rhythm Society and American College of Cardiology published guidance for same-day discharge of cardiac ablation patients during Heart Rhythm 2025, the society’s annual meeting, which was held in San Diego April 26-27.
Sky Labs seeks global expansion of world’s first BP monitor ring
Regulatory
Sky Labs Inc. CEO and founder Jack Byunghwan Lee reported on plans to greatly expand the market for the company’s blood pressure monitor ring, including seeking regulatory approvals for the CART BP products in the U.S., Europe and Japan.
Telix’s brain cancer radiotherapy shows phase II survival benefit
Cancer
Telix Pharmaceuticals Ltd.’s glioblastoma theranostic, TLX-101, is showing promising overall survival in a phase II trial in recurrent high-grade glioma. The targeted radiation therapy, combined with external beam radiation therapy, demonstrated a...
J&J reports completion of first cases with Ottava robotic system
Regulatory
Johnson & Johnson’s Medtech division reported the completion of the first cases in the clinical trial for the Ottava robotic surgical system. The cases mark the first clinical experience with the Ottava system, which has been a long time in...

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