AI

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.

Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.

Vendor exhaustion, insufficient clinical-grade evidence, and outdated risk management are some of the reasons the NHS is struggling to adopt AI.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.

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

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.

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.

Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.

Built on Click’s AI-enabled platform, CT-132 delivers a 12-week behavioral intervention program rooted in multiple evidence-based techniques, including cognitive behavioral therapy (CBT) and bio-behavioral approaches. The goal: reduce brain hypersensitivity and enhance patients’ resilience to migraine triggers.

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.

According to a survey of health care professionals by J&J, over 45% of surveyed respondents reported experiencing symptoms of burnout, including emotional exhaustion and reduced sense of personal accomplishment. This affects not just clinicians, but also the quality and safety of care they deliver. Most clinicians (72%) say that data and technology could significantly help alleviate this burden.

As it celebrates 75 years shaping the medtech industry, Medtronic invited Medtech Insight to its Minneapolis headquarters to get a closer look at the company’s past, what it’s working on now, and what’s on the horizon.

Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.

Reimagine Care teamed up with MedStar Health to support cancer patients at home via an AI assistant and clinical support. Reimagine Care’s data suggests its platform can save cancer centers up to $1m annually per full-time oncologist panel and reduce ED visits by 30%.

“Infectious disease should be treated in the community, not in hospitals,” Alex Batchelor, Pictura Bio CEO, told Medtech Insight at the Anglonordic Life Science Conference on 3 April in London.

AI systems used in healthcare are vulnerable to adversarial cyberattacks, which are a growing concern, said Atif Azad, a professor of AI at Birmingham City University. Azad’s research group has developed a method that trains AI to become more resilient to cyber threats through the use of random image adjustments.

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.

The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.

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.

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.

Beyond the US market, Monogram is actively pursuing regulatory approvals abroad, with India as a key target. The company has partnered with Shalby Hospitals, one of India’s largest orthopedic hospital networks, to conduct clinical trials and accelerate regulatory clearance in the region.