Diagnostic Imaging

Vendor exhaustion, insufficient clinical-grade evidence, and outdated risk management are some of the reasons the NHS is struggling to adopt AI. Haris Shuaib, CEO of Newton's Tree, shared his insights with the audience at the “Next Frontier of Medical AI” event held at DAC Beachcroft's London office on 23 April.

Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.

The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.

ChestView, Gleamer’s newly FDA-cleared solution, is designed for chest X-ray interpretation and is the latest addition to its Gleamer Copilot suite. ChestView, which operates as a computer-aided detection system that can simultaneously detect multiple pathologies on images to support radiologists, is being rolled out in the US.

Egg Medical is ramping up efforts to expand international sales of its EggNest scatter radiation protection system to shield X-ray procedure room staff without disrupting workflow. Medtech Insight sat down with Bob Wilson, Egg Medical’s CEO, to discuss the various EggNest systems, marketing opportunities and the competitive landscape.

Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?

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.

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.

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.

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 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.

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.

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, 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 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.

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 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.

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.

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.

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.