Clinical Trials

LSX Roundup: Startups Elypta, QuantiLight And Plexaa Debut New Tech

 

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.

No Knife, No Burn, Just Bubbles: HistoSonics Hits 90% Tumor Control In #HOPE4Liver Trial, Eyes IPO Timing

 
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HistoSonics, which developed a noninvasive technology to destroy tumor cells, reports 90% local tumor control at 12-month follow-up in the #HOPE4Liver Trial. The Edison System, cleared by the US FDA in late 2023, is also being evaluated for kidney and pancreatic tumors. CEO Mike Blue said the medtech is financially secure but watching public markets as it considers an IPO.

Medtronic Presents Data To Boost Hugo’s Odds Of Getting FDA Nod

 

Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.

First Liver Cancer Surveillance Test In Five Years Receives FDA Breakthrough Status

 

Cambridge-based startup Mursla Bio's liquid biopsy test EvoLiver uses extracellular vesicles to detect hepatocellular carcinoma (HCC) in high-risk cirrhotic patients. Medtech Insight sat down with with Mursla Bio CEO Pierre Arsène.


Biolinq’s $100M In Series C Financing Supports Efforts To Bring Diabetic Glucose Monitoring With Needle-Free Patch To Market

 
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Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.

‘Preparing For Regulatory Milestones, Commercial Launch’ Are Priorities, Says New Freenome CEO Aaron Elliott

 
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Freenome plans to file for US FDA approval of its blood-based screening test for colorectal cancer mid-year. If cleared, the test would rival Guardant Health’s Shield, the first FDA-cleared blood test for primary screening of colorectal cancer. Exact Sciences is also in the race to bring a blood-based colorectal screening test to market.

CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

 

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.

Anglonordic 25: Women’s Health Needs Therapeutic Success To Encourage Wider Investment

 

Health tech is at the forefront of the women's health sector, securing 38% of venture capital in 2024. However, panelists at the Anglonordic Life Science Conference held 3 April asserted that a successful therapeutic breakthrough is key to gaining investor confidence and accelerating venture capital.


Abbott’s TriClip Reduces Severity Of Tricuspid Regurgitation Two-Year Results Confirm

 

Abbott presented late-breaking data at the 2025 American College of Cardiology conference demonstrating that TriClip transcatheter edge-to-edge repair offers prolonged patient benefits compared to medical treatment alone after two years, which were not evident at one year.

Exact Sciences Launches Cologuard Plus

 

The Cologuard Plus test has a sensitivity of 95% and a specificity of 94% for the detection of colorectal cancer; “unmatched accuracy,” according to Exact Sciences.

LSI 2025: Vektor Medical CEO Says ‘Arrhythmia Is The Biggest Health Care Crisis Nobody Talks About,’ vMap Treats It With 91.1% Accuracy

 
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Vektor Medical is ramping up efforts to bring its vMap technology used to identify arrhythmia sources to more US hospitals, start enrollment in a multinational trial, and commercialize in Europe, pending the CE mark. Medtech Insight sat down with CEO Rob Krummen at LSI 2025 to discuss their plans.

Owlstone Medical Develops P.aeruginosa Breath Test For Cystic Fibrosis Patients

 

Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.


Urine Test Could Halve Number Of CT Scans For Patients With Kidney Cancer

 

The urine-based GAGome test showed promise in the first clinical results from the international AURORAX-0087A, in the largest study conducted on clear cell renal cell carcinoma, the most common type of kidney cancer.

European Medicine Agency’s CHMP Qualifies First AI Tool For Use In Clinical Trials

 

With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.

Wired Health: One-Size-Fits-All Wearables Don’t Work For Women’s Health

 

Wearable technology must address women’s unique needs, said Anja Streicher, Women of Wearables chief marketing officer. Samphire Neuroscience and Amira Health demo wearable solutions for PMS and hot flashes at Wired Health.

Quibim Extends Into US Market With FDA Authorization Of QP-Prostate CAD

 

The US FDA's clearance of QP-Prostate CAD positions the company to support US health care providers and growing markets for fusion biopsy and focal therapy, said Quibim CEO and founder Angel Alberich-Bayarri.


Neuromod Raises $10.9M To Grow US Reach And Further Real-World Evidence

 

Dublin-based Neuromod has closed a €10m ($10.9m) series B funding round to bring a "new standard of care" to patients with tinnitus.

Prostate Cancer Research Urges UK To Implement Screening Program Without Delay

 

Implementing a reflex test alongside traditional prostate cancer screening is cost-effective for high-risk groups, claims Prostate Cancer Research. Oxford BioDynamics sheds light on UK market conditions influencing the adoption of its reflex test, EpiSwitch PSE.

Digostics At-Home Type 1 Diabetes Test Trialed In Children For Routine UK NHS Use

 

Researchers from the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Center are testing Digostics’ GTT@home test in children to assess if it offers a better alternative to the clinical gold-standard oral glucose tolerance test.

More Patients Free From Atrial Fibrillation With AI-Guided Pulmonary Vein Isolation Treatment

 

Volta Medical’s TAILORED-AF clinical trial demonstrates that AI can achieve "superior efficacy" in interventional cardiology. The study examined the use of AI-driven Volta AF-Xplorer in addition to pulmonary vein isolation in treating patient with persistent atrial fibrillation.