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BioWorld - Monday, July 13, 2026
Home » Topics » Medical technology

Medical technology
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Regulatory actions for May 17, 2024

May 17, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, BD, Brainomix, Diasorin, Implicty.
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Other news to note for May 17, 2024

May 17, 2024
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adagio, Circle Cardiovascular, Cook, Enterasense, Inheart, Lifecore, Oxford Biodynamics, Siemens Healthineers, Varian.
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In the clinic for May 17, 2024

May 17, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angle, Caredx, Heartflow, Myriad.
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Appointments and advancements for May 17, 2024

May 17, 2024
New hires and promotions in the med-tech industry, including: Full-Life Technologies, Merit Medical Systems, Osteotec, Quest Diagnostics, Spectral AI.
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oragami-heart-monitor
Patents

Researchers develop origami-like device for heart monitoring

May 17, 2024
By Simon Kerton
Wubin Bai, assistant professor of applied physical sciences at UNC-Chapel Hill, is seeking protection for morphable 3D-folded microelectronic mesostructures, including epicardial bioelectronic probes, made using concepts borrowed from origami.
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Arcscan

China approves Arcscan’s ultrasound imaging device for myopia

May 17, 2024
By Marian (YoonJee) Chu
Denver-based Arcscan Inc. gained Chinese approval of its computer-controlled, ultra-high frequency ultrasound diagnostic imaging solution for myopia called Insight 100, expanding its reach beyond the U.S. and Europe.
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FDA website and logo
FDLI Annual Meeting

Recent FDA activity hints at impending commercial speech enforcement

May 17, 2024
By Mark McCarty
The U.S. FDA has several methods for signaling its enforcement intentions regarding medical devices and drugs, but there are times when warning letters are the vectors for communicating the agency’s current thinking.
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omniasecure defib lead
HRS 2024

Omniasecure defibrillation lead exceeds LEADR performance goals

May 17, 2024
By Holland Johnson
Medtronic plc said its investigational Omniasecure defibrillation lead met its primary safety and effectiveness endpoints and exceeded prespecified performance goals, in the global Lead Evaluation for Defibrillation and Reliability (LEADR) pivotal trial.
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Gloved hands holding a heart

Caredx Heartcare quickly IDs organ rejection, improves outcomes

May 17, 2024
By Annette Boyle
The Surveillance Heartcare Outcomes Registry trial demonstrated that Caredx Inc.’s Heartcare test identifies acute cellular rejection in heart transplant patients better than donor-derived cell-free DNA (dd-cfDNA) alone, while reducing biopsies and improving clinical outcomes. Heartcare combines two non-invasive tests, dd-cfDNA and Allomap Heart gene-expression profiling.
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U.S. flag and money

US FTC meets reality on budget request amid overreach concerns

May 16, 2024
By Mari Serebrov
The FTC’s request for a nearly 25% increase in funding for fiscal 2025 was splashed with cold water May 15 in a U.S. House Appropriations subcommittee hearing. That’s “a dramatic increase in funding for an agency whose work continues to raise concerns among many members of Congress and the public,” Rep. David Joyce (R-Ohio), chair of the Subcommittee on Financial Services and General Government, said as he opened the hearing.
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