In this episode of Medtech Connect, Medtech Insight spoke to three decentralized clinical trial experts at Hogan Lovells: partner Kristin Zielinski Duggan, partner Blake Wilson and associate Stephanie Agu. We discussed the ins and outs of the draft FDA guidance document, what pieces of the guidance still might need clarification and how they expect to see the industry change as DCTs become mainstream.
Decentralized Clinical Trial Guidance Fulfills Promise, Underlies Digitization Of Healthcare
FDA Seeks Feedback On Attempt To Modernize Clinical Trials
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Medtronic beat first-quarter revenue and EPS estimates, raised guidance, and added two board members and special committees as Elliott takes a stake.
AI-driven medtech M&A slowed slightly in volume but tripled in value in early 2025, with buyers focusing on AI-driven diagnostics, surgical tech and analytics. Industry experts expect continued high-value deals as firms defend market share and pursue workflow-enhancing AI.
Philips says the expansion of its facility in Reedsville, PA, will not only boost its capacity to produce AI-enabled ultrasounds that are used in hospitals across the US but will also create 120 well-paying jobs.
Freespira’s device has been FDA-approved to treat panic disorders and PTSD. CEO Joe Perekupka told Medtech Insight the company’s innovative approach includes patient coaching, insurance partnerships to identify potential users, and lobbying for broader insurance coverage for digital therapeutics.
Medtronic beat first-quarter revenue and EPS estimates, raised guidance, and added two board members and special committees as Elliott takes a stake.
Entrepreneurialism is in the blood of Israel’s medtech innovators, but in a changing medtech world, the local ecosystem must address funding gaps and manufacturing and infrastructure needs. So says Ruti Alon, experienced Israeli medtech leader, investor and co-chair of the Biomed Israel conference.
A Japanese study of Watchman LAA closure devices found that leaks of any size after implantation raise the risk of stroke. The study comes shortly after the US FDA issued an early alert for the Watchman access systems.
