Diagnostic Imaging

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.

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.

ECRI Ranks Lack Of AI Governance, Cyberattacks Among Top Patient Concerns For 2025

 

Artificial intelligence could compromise patient safety if not properly governed, ECRI said in its new top 10 list of patient concerns for 2025. Other potential hazards include cybersecurity breaches, diagnostic errors, and misinformation.

China Strikes Back After Trump Ups Tariffs; Administration Further Delays Tariffs On Canada And Mexico

 

In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.


ACLA: Clinical Labs Hold ‘The Power Of Knowing’ For Patients

 

ACLA wants policymakers to see the vital role clinical labs play in delivering better health outcomes for patients and improving public health, especially in their potential for catching diseases early.

New AI Tool Spots ‘Invisible’ Epilepsy Brain Lesions Missed By Radiologists

 

MELD Graph could help speed up the diagnosis and treatment of people with epilepsy by spotting "invisible" brain lesions often missed by radiologists. The new open-source AI tool developed by UK researchers could save the NHS up to $70,000 per patient, said researchers.

China Volatility Drags On Outlook For GE HealthCare But CAPEX More Buoyant

 
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The US market’s largest imaging manufacturer marked two years as an independent company with plans to invest in more M&A and PDx production capacity, but reported a modest 2025 revenues outlook.

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.


Avandra CEO Expects White House AI Czar David Sacks Will Usher In ‘Golden Age Of Innovation And Medicine’

 
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Avandra CEO says the company has created the world’s largest federated network for de-identified imaging data, providing researchers access to medical images that will accelerate the advancement of clinical trials, precision medicine and AI applications.

CES 2025: Scouting Digital Health Floor With Deloitte Analysts To Discover Emerging Trends

 
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During CES 2025, Medtech Insight accompanied Deloitte analysts Neal Batra and Andrew Davis to identify the biggest trends in digital health and solutions poised to transform the future of health care. Key trends included empowering consumers with actionable health data, the rising investment in specialized areas such as women’s health, and more companies pursuing regulatory clearance for health products.

Quibim $50m Series A To Fund High-Performance Computing And US Expansion

 

Quibim announces $50m in an oversubscribed series A funding round. Quibim CEO Ángel Alberich-Bayarri discusses his plans for the new financing and the company’s competitive edge in training AI with multimodal data.

Two Deaths Linked To Philips Recall of Heart Monitoring Software

 

A failure to properly route cardiac events has led Philips to recall its heart monitoring software that interprets ECG data. Multiple injuries and two deaths are associated with the problem.


Digital Health Roundup: 2025 Will See More AI/GenAI Adoption In Medtech, FDA’s Digital Health Push, UK Pilots

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.

FDA Flags High-Risk Recall: Hologic’s BioZorb Markers Under Scrutiny

 
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The US FDA has labeled Hologic’s BioZorb Markers recall as Class I high-risk, highlighting safety concerns about devices cleared via the 510(k) pathway. The recall is due to reports of adverse events tied to the radiographic markers.

News We’re Watching: Schwarzenegger ZB’s Chief Movement Officer; J&J Ottava Enters Clinical Trials; Dassault, FDA Develop First Guide For Virtual Twins

 

This week, Zimmer Biomet announced a new role of chief movement officer for Arnold Schwarzenegger, J&J MedTech receives IDE approval for Ottava, Dassault Systèmes with US FDA develop first guide for virtual twins, Mainz Biomed and Thermo Fisher team up to fight colorectal cancer.

La French Touch: How France Has Built a Reputation for Excellence In Medtech

 

France’s medtech sector is strong, growing and innovative. Medtech Insight spoke to several French medtech leaders about the unique features and pitfalls their industry may face.


Digital Health Roundup: GE HealthCare On AI At HLTH; Medtech Conference Panel; Graphene Brain Implant; Unicorns & More

 

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia about his vision for AI in health care and other highlights from HLTH. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.

Cover Supplemental Breast Screenings, AdvaMed Urges Medicare

 

AdvaMed is calling on Medicare to provide coverage for supplemental screenings for women with dense breasts, an anatomical characteristic that puts them at a higher risk for cancer. The trade group says the lack of coverage for additional imaging results in many women not receiving potentially lifesaving follow-up.

HLTH 2024: GE HealthCare’s Chief AI Officer Says Future Of AI No Longer A Black Box

 
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Medtech Insight talked with GE HealthCare’s chief AI officer Parminder “Parry” Bhatia at HLTH about the firm’s new CareIntellect for Oncology offering to help clinicians make efficient use of multimodal patient data, his vision for projects within AI Innovation Lab, and the future of AI in health care.

7 Start-Ups At HLTH 2024: Shaking Up Medtech’s Business Model, ‘AI’ For Cancer Detection, MCI Assessment, Validation, Monitoring

 
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Medtech Insight was on the ground at HLTH looking for innovative companies. Learn about seven start-ups using AI to help physicians detect conditions including prostate and breast cancers, seizures and heart failure; assess patients for cognitive decline validate and deploy algorithms, and monitor patients in and out of the hospital.