Aortyx secures €13.8M for aortic dissection solution
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 a deployer.

FDA approves Medtronic Omniasecure defib lead
Medtronic plc received U.S. FDA approval for its Omniasecure defibrillation lead for placement in the right ventricle to treat arrhythmias. Medtronic said the lead is the smallest made at 4.7 French or 1.6 mm, making it suitable for individuals as young as age 12 and others with smaller anatomies, particularly women.

Aortyx secures €13.8M for aortic dissection solution
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 a deployer.
FDA approves Medtronic Omniasecure defib lead
Medtronic plc received U.S. FDA approval for its Omniasecure defibrillation lead for placement in the right ventricle to treat arrhythmias. Medtronic said the lead is the smallest made at 4.7 French or 1.6 mm, making it suitable for individuals as young as age 12 and others with smaller anatomies, particularly women.
Gut microbiome leads to metabolic and immune changes after transplant
Is fecal microbiota transplant effective? Is it really safe? And is it really all the same? Scientists at the University of Chicago have investigated the regional differences in gut environments to question these interventions.
Pharmalytix files patent for insulin degradation home test
In what represents the company’s first filing, the co-founders of Pharmalytix Inc., Sierra Houang and Lee Grady, describe their creation of a simple, quick, low-cost at home lateral flow test for determining insulin quality.
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.
Today's news in brief
BioWorld MedTech briefs for June 13, 2025.

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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

Wandercraft secures $75M in series D funds for robotics portfolio
Orthopedics
Wandercraft SAS secured $75 million in funding in a series D round to grow its AI-powered robotics solutions. Funds will be spent on its exoskeletons, Atalante X and Eve, as well as on the industrial development and rollout of Calvin 40, its humanoid robot.

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

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...
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 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...
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.

Europe

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.

Asia-Pacific

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.

Alexandra Hospital team patents new AI robotic knee surgery
Artificial intelligence
A research team led by consultant and orthopedic surgeon Glen Liau Zi Qiang from Alexandra Hospital in Singapore developed a new AI algorithm to improve the accuracy and efficiency of robotic total knee arthroplasty (rTKA) surgery.
EBR Systems raises $36M to sell Wise CRT therapy
Financings
EBR Systems Inc. raised AU$55.9 million (US$36 million) to commercialize its Wise cardiac resynchronization therapy system following U.S. FDA approval in April of the wireless, endocardial pacing system to stimulate the heart’s left ventricle.

Clinical

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...
FDA greenlights Distalmotion’s Dexter for gallbladder removal
Regulatory
The U.S. FDA granted 510(k) clearance to Distalmotion SA's Dexter, its surgical robotic system, for use in cholecystectomy in adults. The greenlight from the regulatory body is the second nod Dexter has received following de novo clearance granted...
In TAVR setback, Boston Sci pulls plug on Acurate valves
Cardiovascular
Boston Scientific Corp. reported the latest setback in its transcatheter aortic valve replacement (TAVR) aspirations with the news that it is officially discontinuing worldwide sales of its Acurate neo2 and Acurate Prime systems

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