New Technology

Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.

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.

Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.

Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and the addition of 14 AI-driven algorithms to enhance surgical workflow.

This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.

Voluson Signature 20 and 18 ultrasound provides clinicians with workflow efficiencies in detecting female reproductive health problems, especially those related to pregnancy.

The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.

Topline results from two studies in obstructive sleep apnea among obese adults showed efficacy crossing the 50% threshold that physicians have called clinically meaningful.

The US FDA has cleared a novel software application to enhance the analysis of bone marrow smears. Using the AI-powered tool, hematopathologists may be able to better diagnose various blood and marrow diseases.

Philips CEO Roy Jakobs talks to Medtech Insight about the medtech firm’s decade-long history of embedding AI into its products and what he expects from the newly released draft framework by the National Academy of Medicine, which he helped develop as co-chair of the Steering Committee.

Ekso Bionics’ exoskeleton received a final payment determination from the Centers for Medicare and Medicaid Services, paving the way to faster rehabilitation for more patients.

The National Academy of Medicine developed a code of conduct for health care AI development, as well as commitments for code implementation. 

At the recent Precision Med Tri-Con conference, health care leaders and AI enthusiasts Eric Topol and Doug Flora discussed how AI integration will change the way doctors practice medicine and patients receive care.

This week, Abbott, Click and Otsuka, Prenosis won the FDA nod respectively for an in vitro diagnostic to evaluate patients for concussion, the first prescription digital therapeutic to treat major depressive disorder and a software to predict sepsis. Also on the regulatory front, the FDA will now take 513(g)s forms via its eSTAR framework. In Europe, the debate of what personal information can be shared continues. 

Abbott wins FDA approval for TriClip regurgitation therapy, which will compete against Edwards Lifesciences’ recently approved Evoque transcatheter tricuspid valve replacement device. Two analysts expect Tricuspid will be eligible for a new technology add-on payment, which will be positive for Abbott.

The US FDA has cleared an AI tool from Eko Health that could help doctors detect heart failure during routine physical exams. Developed with the Mayo Clinic, the tool can pick up a key early indicator for heart failure, which can often go undiagnosed.