Clinical Trials

TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
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The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.


Mirvie Launches Predictive Blood Test For Preeclampsia

 
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Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.

SpotitEarly Raised $20.3M In New Funding To Bring AI- And Dog-Sniffing-Powered Early Cancer Detection Test To US

 
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Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.

LSX Europe: Women’s Health Education Is The Key For Unlocking VC Investment

 

Flo Health was the first femtech unicorn to be valued at over $1bn. But the company faced 49 investment rejections before reaching that status, Anna Klepchukova, the company’s chief medical officer, told the LSX World Congress Europe. THENA Capital’s Esther Reynal de St Michel Richardot talked through the firm’s gender-smart investment strategy.

Synchron And Apple Team Up To Use ‘Mind-Thought Connection’ To Control iPhones, iPads

 
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Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.


Abbott’s FreeStyle Libre CGM Reduces Cardiovascular Disease-Related Hospitalization

 

The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.

Axoft Starts Commercializing Soft BCI-Enabling Materials For R&D Use, Aims To Rewrite BCI Playbook

 
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After publishing encouraging results from first-in-human trials of its brain-computer interface, Axoft announced plans to sell its BCI-enabling material Fleuron to researchers and private organizations for R&D use. The company sees this as a revenue stream and feedback loop to refine its BCI platform designed for safer, longer-lasting brain implants.

Peerbridge Bets On At-Home Heart Monitoring With Rechargeable, Longer-Lasting ECG Patch

 
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Peerbridge Health is preparing to submit its next-generation ECG patch, CorMDx, for US FDA clearance this quarter, with plans to launch in the second half of 2025. The rechargeable device is designed for continuous, real-time heart monitoring from the hospital to home, aiming to detect early signs of heart failure and reduce emergency room visits.

Subsense Develops Nonsurgical, Nanoparticle-Based Brain-Computer Interface For Neurological Disorders

 
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Neurotechnology start-up Subsense came out of stealth with $17m in seed funding to develop a nonsurgical, nanoparticle-based brain-computer interface. Medtech Insight spoke with the firm’s new neurotech lead Cyril Eleftheriou about the technology and its potentially wide applications for treating Parkinson’s, epilepsy, inner speech decoding, and more.


AAOS 2025 Orthopedic Roundup: J&J Velys UKA, Stryker Mako 4, Materialise, Canary Medical

 
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At AAOS, orthopedics players showcased their latest robotic-assisted platforms, power tools, 3D printed technologies and software offerings. This article brings you highlights from interviews Medtech Insight conducted on site with representatives from J&J, Stryker, Materialise and Canary Medical.

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.