Advamed


Supreme Court Rebuke Of Trump Tariffs A Win For Medtech

 

The US Supreme Court struck a blow to the Trump administration’s efforts to impose sweeping tariffs, ruling the president exceeded his authority. Limiting tariffs has been a priority for the medtech industry.

Luminoah Aims To Deliver Personalized, Data-Driven Nutrition And Dignity For Tube-Fed Patients

 
• By 

Inspired by his son’s battle with cancer, Neal Piper founded Luminoah to modernize enteral feeding. Its smart, pocket-sized pump tracks nutrition in real time to prevent malnutrition and improve quality of life for patients and caregivers.

Adapting to Tariffs and Tech: Ireland’s Strategy to Keep Medtech Thriving

 
• By 

John Nugent, who heads the medtech division at Irish business development agency IDA Ireland, spoke to Medtech Insight about how the country’s 75-year focus on encouraging medtech innovation is shifting in the light of digital health, AI, tariffs, and other new challenges.

‘From Diagnostics To Prognostics’: Google Cloud Healthcare Director Sees AI As Healthcare’s Future

 
• By 

Google Cloud healthcare lead Shweta Maniar talked with Medtech Insight about improving health monitoring, boosting regulatory collaboration, and deepening integration of technology in medical practices.

CES


Women’s Health Investment Poised For Rebound In 2026

 
• By 

After a steep drop in 2025, women’s health investment is expected to rebound in 2026, driven by renewed focus on menopause, certain chronic conditions and mental health, as well as a shift toward clinically validated products.

Abbott Says Plans To Launch Dual Diabetes Sensor Unimpeded By Latest Warning Letter

 

A warning letter from the US FDA citing concerns of some Abbott continuous glucose monitors will not stop the company from launching a novel diabetes sensor later this year as planned.

ces 2026

Among The Razzle-Dazzle, Surgical Science Quietly Pitched Simulator For Robotic Surgical Training

 
• By 

Amid the spectacle of humanoid robots at CES 2026, Swedish medical simulation company Surgical Science opted for a quieter pitch for its suitcase-sized robotic surgery simulator aimed at taking training out of the OR.

Industry Says FDA Loosening Regs On Wearable And Digital Products Is Good For Innovation

 

The US FDA has updated a pair of guidance documents relaxing the agency’s posture on how it regulates general wellness devices and clinical support software. Industry has mostly welcomed the changes, agreeing with the agency’s view that lighter regulation will help spur innovation.

Digital Therapeutics Alliance


DTX Companies Find New Niche As Complement To Standard Of Care

 
• By 

Digital therapeutics aren’t going away anytime soon, but they are positioning themselves as a complement to traditional therapies.

At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use

 
• By 

At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.

‘It’s Not Going To Happen Overnight’: Payors On Pear Fallout And Digital Therapeutic Coverage Prospects

 

Public and private payors at the Digital Therapeutics Alliance’s 2023 Inaugural Summit weighed in on the coverage environment for prescription digital therapeutics post-Pear Therapeutics and strategic moves companies can make to position themselves advantageously.

DTA Panel Discusses Future Of Digital Therapeutics, Obstacles To Wider Adoption

 
• By 

A panel discussion between health professionals, industry groups and digital therapeutics innovators at the DTA Summit highlighted opportunities and barriers for the development and adoption of digital therapeutics.

HIMSS


Numares Targets Kidney Transplantation ‘Blind Spot’ With Metabolomics-Based Urine Test

 
• By 

Numares Health bets on a metabolomics-based urine test to help doctors detect kidney transplantation rejection earlier than current biomarkers, which would allow doctors to intervene earlier in trying to save the transplanted organ.

HIMSS 2026: Hospital Tech Leaders Discuss AI Integration, ROI And Clinical Pain Points

 
• By 

During panel discussions at HIMSS 26 focusing on AI-based tech integration at health systems, tech leaders from Mass General Brigham, City of Hope, Vanderbilt University, and Philips, stressed that start-ups need to solve clinical problems that integrate into workflows and deliver ROIs quickly.

Digital Health Roundup: Intuitive Surgical CEO Exec Chat, AI Alert System, FDA, Roche New NGS Prototype

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights her conference coverage from CES, HIMSS, AAOS and LSI including Exec Chats with Gary Guthart, CEO of Intuitive Surgical, and Arcadia’s chief strategy officer Aneesh Chopra. Brian Bossetta highlights a recently FDA-cleared alert system that sends vital signs to clinicians. Elizabeth Orr discusses FDA warning letters sent to Exer Labs for exceeding marketing claims under what is allowed under the device’s 510(k) clearance. Shubham Singh discusses how Roche's unveiling of its next-generation sequencing (NGS) prototype challenges Illumina. The SBX technology is set to compete directly with Illumina’s NovaSeq and NextSeq platforms.

HIMSS 2025: Interview with Aneesh Chopra, Arcadia’s Chief Strategy Officer, About The Future Of Health Data, Interoperability, AI

 
• By 

Medtech Insight sat down with Arcadia's chief strategy officer Aneesh Chopra to discuss interoperability, industry standards and the future of health care data and AI.

HLTH


Viome’s CEO To Expand Into Clinical Diagnostics ‘For Which There Are No Solutions’ With AI, RNA Test

 
• By 

Viome Life Sciences accelerates its push into clinical diagnostics with studies in colorectal cancer and a major partnership with Microsoft to scale its molecular data analysis platform. Viome leverages RNA analysis and AI to detect disease at the molecular level and personalize preventive health.

Delfi Diagnostics Fragmentomics Lung Cancer Test Nears Key Milestone For FDA Path, Reimbursement

 
• By 

Delfi Diagnostics is preparing for pivotal trial results that could support FDA approval and reimbursement for its fragmentomics-based lung cancer screening test. Early data suggest strong potential to improve screening uptake and expand access to early detection.

LinusBio Extends Hair-Based Diagnostic Beyond Autism, Expands Into Japan

 
• By 

After rolling out its hair-based autism diagnostic across the US, LinusBio is expanding into Japan and testing its “molecular movie” technology for ALS and other neurological disorders, aiming to deliver the first objective biomarkers in pediatric and neuropsychiatric care.

Astrin Biosciences To Launch First Blood-Based Test For Early Breast Cancer Detection, Dense Breasts

 
• By 

Astrin Biosciences will debut Certitude, a proteomics-based blood test for women with dense breasts, aiming to detect early breast cancer with MRI-like accuracy and outperform current supplemental imaging.

J.P. Morgan


Illumina Pins 2026 Growth On Clinical Sequencing As Research Spending Stays Constrained

 
• By 

Illumina CEO Jacob Thaysen told JPMorgan analysts that clinical consumables, NovaSeq X adoption will anchor company’s near-term outlook amid muted academic demand.

GE HealthCare Sets Long-Cycle Expectations For Photon-Counting CT, PET Tracer Flyrcado

 
• By 

GE HealthCare CEO Arduini believes the imaging market is large enough to accommodate multiple players as adoption progresses, describing photon-counting CT as a long-cycle transition rather than a near-term shift.

Insulet Leans On Manufacturing Scale And Omnipod Launches As Patch Pump Competition Broadens

 
• By 

While several competitors are developing or launching patch pumps, Insulet CEO McEvoy described Omnipod as differentiated by both technology and manufacturing scale. She said the company has invested roughly $3bn across R&D and manufacturing.

Siemens Healthineers Targets 5–6% Growth, Rules Out Large M&A As Tariff Mitigation Takes Shape

 
• By 

Siemens Healthineers expects to grow revenue by mid-single digits in fiscal 2026, assuming no contribution from China for a second consecutive year.