Strategy

Roche’s $50Bn Bet On US Manufacturing: Tariff Shield But Cash Flow Strain

 
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New continuous glucose monitoring manufacturing site in Indiana is part of Roche’s plan to boost its US presence. Roche’s launch of Accu-Chek SmartGuide system last year with AI-powered prediction capabilities puts it as a key differentiator from competitors such as Abbott and Dexcom.

Analysts See Insulet’s Appointment Of Ashley McEvoy As CEO As A Positive Move

 
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Diabetes company Insulet announced that former longtime J&J executive Ashley McEvoy will succeed Jim Hollingshead as president and CEO effective today. Analysts applauded the appointment, noting McEvoy’s strong background in medtech and diabetes.

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.

OneCell Diagnostics – Now 1Cell.Ai - Launches Multi-Modal Cancer Diagnostic Panel OncoIncytes

 

OneCell Diagnostics, the Mumbai-based startup backed with $16m in series A funding, is rebranding to 1Cell.Ai to represent the firm's focus on combining deep science with AI-powered capabilities.


Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 

“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.

Diagnostics Are Essential, But How Can Companies Ensure A Fair Price?

 

Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?

Enovis Appoints Damien McDonald CEO, Reaffirms Q1 Guidance Amid Strategic Growth Push

 
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Enovis has named veteran medtech leader Damien McDonald as its new CEO effective 12 May as the orthopedic company reaffirms first-quarter 2025 revenue guidance of between $555m and $563m. Medtech Insight spoke with Tim Czartoski, Enovis’ president of US surgical and global product and enabling technologies, about the firm’s growth strategy and innovation plans.

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.


THENA Capital ‘Makes History’ As UK’s First All-Female Early-Stage Medtech Fund

 

Only 16% of venture capital general partners in Europe are women, and only 9% of those have actual investment power. Thena Capital is aiming to "redefine the image of a venture capitalist."

LSI 2025: Intuitive Surgical CEO Gary Guthart On da Vinci 5’s Force Feedback, Digital Coaching, ION Expansion, And Robotic Surgery’s Future

 
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Medtech Insight sat down with Intuitive Surgical CEO Gary Guthart at the recent LSI USA conference to discuss the full launch of the new da Vinci 5 robotic system and planned digital enhancements. Guthart also offered his views on health care interoperability, AI regulation, outpatient surgeries, autonomous robots, and how the company is harnessing technology to shape the future of robotic surgery.

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.

AAOS 2025: AcuityMD Study Finds Innovation Continues To Drive Outpatient Spinal Procedures

 
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A new study by AcuityMD, presented at AAOS 2025, highlights the continued shift of spinal surgeries to the outpatient setting, with state-by-state variability in ASC adoption. While hospitals still dominate spinal procedures, advancements in minimally invasive techniques and medical technologies are major drivers of spinal surgeries in the ASC setting.


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.

Libre 3 Sensors: With Second Plant Online, Abbott Aims For Under-Penetrated ‘Intensive Insulin’ Segment

 
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Abbott’s international sales could be a key driver as firm looks to partnerships with insulin pump companies.

Dexcom Eyes US FDA Clearance For 15-Day CGM, But Insurance Coverage Remains Uncertain

 
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Tempering expectations on the immediate market impact for the upgraded continuous glucose monitor, Dexcom notes insurance coverage and pump integrations will take time to finalize.

HIMSS 2025: Panel Discusses Interoperability In Health Care, Opportunities And Challenges

 
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During a panel discussion at HIMSS, experts highlighted the shift in digital health funding in 2024 with “mega funds” dominating the space and big tech companies developing foundational models that large health care customers use to address multiple use cases. They noted, however, there is ample room for smaller companies to develop technologies adjacent to incumbent systems.


Boston Scientific Targets Multi-Billion Hypertension Market With SoniVie Acquisition

 

Boston Scientific has entered the multi-billion hypertension treatment market with the acquisition of Israel-based startup SoniVie, developer of the TIVUS intravascular ultrasound system for the treatment of high blood pressure by artery nerve ablation.

Medtech M&A Is Thriving, Reports McKinsey

 

Only one year in the last decade involved more medtech acquisitions worth over $1bn than 2024, said McKinsey. A new report from the consulting firm found that despite an overall fall in activity for the life science sector, the economic and regulatory environment may support a strong rebound in dealmaking.

Seonix Bio’s Newly Launched Saliva-Based Genetic Test Aims To Shed Light On Glaucoma Risk Assessment

 
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Seonix launched SightScore, the first clinical polygenic risk score test for glaucoma available in the US, and plans to introduce more genetic-based tests for eye conditions such as macular degeneration.

PathAI Enters South American Market Partnering With Integrated Healthcare Network Rede D’or

 

PathAI, a Boston-based AI-pathology startup backed by $355m, partners with Brazil’s largest integrated healthcare network to support diagnosis and treatment of cancer patients using its AISight image management system.