Advamed
Inspired by his son’s battle with cancer, Neal Piper founded Luminoah to modernize enteral feeding. Its smart, pocket-sized pump tracks nutrition in real time to prevent malnutrition and improve quality of life for patients and caregivers.
John Nugent, who heads the medtech division at Irish business development agency IDA Ireland, spoke to Medtech Insight about how the country’s 75-year focus on encouraging medtech innovation is shifting in the light of digital health, AI, tariffs, and other new challenges.
Google Cloud healthcare lead Shweta Maniar talked with Medtech Insight about improving health monitoring, boosting regulatory collaboration, and deepening integration of technology in medical practices.
Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.
Armor Medical’s wrist-worn wearable detected postpartum hemorrhage five times earlier than standard care in earlier studies. After surviving near-fatal hemorrhage herself, co-founder/CEO Kelsey Mayo aims to bring the device to market in 2028.
During a town hall session at AdvaMed’s MedTech Conference in San Diego, US FDA device center head Michelle Tarver discussed the center’s successes in product approvals, digital health, home healthcare and more amid a tumultuous year.
Family offices, impact funds, and public-private partnerships are among alternative approaches to financing that stress early-stage investment, collaboration, impact and health equity – but not, at least for family practices, AI.
At the MedTech Conference, the CEOs of Stryker, Hologic and Insulet said during a panel AI is now central to their business strategies, from creating new medical devices to streamlining workflows and administrative tasks. Stryker’s CEO Kevin Lobo plans a business unit focused on AI-enabled tech.
At AdvaMed’s MedTech Conference in San Diego, speakers brainstorm ways to bring devices to treat children to market more quickly through creative collaboration, better use of real-world data, and taking advantage of ‘low-hanging fruit’ like expanded size ranges.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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.
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.
During the Medtech Conference in Toronto, a panel of industry leaders discussed the gaps that remain in women’s healthcare and said innovation can help narrow them.
In her inaugural address to the medtech industry during the Medtech Conference, acting US CDRH director Michelle Tarver described her mission-driven approach.
As the 6 May deadline to implement the FDA’s final rule on lab-developed tests approaches, attempts to stop the rule from taking effect are set to play out in court. A panel of experts discussed the potential impact of these legal efforts, should they be successful, at the Medtech Conference in Toronto.
During the Medtech Conference in Toronto, three of the industry’s leading CEOs shared their insights into the rapidly changing landscape of health care and how the latest advancements have the potential to make life better for patients everywhere.
The AI/ML pre-determined change control plan final guidance will include plans for agency-wide training for the implementation of PCCPs, an FDA deputy director said at the Medtech Conference.
CDRH is on track to meet its MDUFA V goals, seeing a steady return to pre-pandemic levels of device authorizations and submissions.
Investors and business executives weighed in on the FDA’s proposed rule on LDTs during a panel at the Medtech Conference on 9 October.
As diagnostics have become more technologically advanced and are used more frequently in detecting diseases, uniform regulatory standards have become necessary, according to a panel of experts discussing testing reform at the MedTech Conference in Boston.