Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

Salvia Bioelectronics Secures $60M In Series B To Advance Chronic Migraine Implant, Eyes US Trials

 
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Medtech Insight spoke with Hubert Martens, CEO of Netherlands-based neuromodulation company Salvia Bioelectronics, about the company’s innovative implant for treating chronic migraines, ongoing clinical trials and plans for US clinical trials and commercialization.

Bone Surgery Startup Surgify Medical Raises $7.9m

 

Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.

German Bionic Launches ‘Strongest Exoskeleton To Date’

 

German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.


FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
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The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

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.

Thousands Of Cardiac Digital Twins Reveal Novel Connections With Mental Health

 

King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.


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.