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

Medical technology
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Regulatory actions for May 15, 2024

May 15, 2024
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acclaro, Oxehealth, Qiagen, Roche.
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Other news to note for May 15, 2024

May 15, 2024
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Corepath, GTC, IDT, Molecular Health, Neuronetics, Rapid Medical, Sevaro.
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In the clinic for May 15, 2024

May 15, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Enable Biosciences.
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Financings for May 15, 2024

May 15, 2024
Med-tech firms raising money in public or private financings, including: Aethlon Medical, T2 Biosystems.
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Appointments and advancements for May 15, 2024

May 15, 2024
New hires and promotions in the med-tech industry, including: Enhanc3D Genomics Ltd., Geneoscopy Inc.
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Cyber eye illustration
FDLI Annual Meeting

US legislation for AI described as ‘long-term process’

May 15, 2024
By Mark McCarty
Artificial intelligence recently roiled the regulatory world, but the U.S. Congress has yet to dive into the task of legislating on the concept. Barrett Tenbarge, general counsel for Sen. Bill Cassidy (R-La.) told an audience here in the nation’s capital that while the Senate is considering several legislative proposals, the desire to avoid legislation that will create as many problems as it solves suggest that legislative development “is a long-term process.”
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Stereotaxis robotic magnetic navigation (RMN) system

Stereotaxis to buy EP catheter maker Access Point Technologies

May 15, 2024
Stereotaxis Inc. said it is buying electrophysiology catheter maker Access Point Technologies EP Inc. to enhance its minimally invasive endovascular surgical robotics technology offerings.
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Chanelle Case Borden pipetting DNA samples into a tube for polymerase chain reaction.
FDLI Annual Meeting

FDA’s Califf calls on labs to ‘wake up and develop better tests’

May 15, 2024
By Mark McCarty
The U.S. FDA’s final rule for regulation of lab-developed tests promises to remain controversial for the foreseeable future, but FDA commissioner Robert Califf said that many of these tests have been shown to be less than adequately reliable. Califf said that one of the effects of the final rule is that it will force clinical labs to “wake up and develop better tests,” if only because compliance and enforcement regimes will soon be applied to clinical labs.
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Neural Ice

Brixton comforted by $33M series B for pain relief therapy

May 15, 2024
By Annette Boyle
Brixton Biosciences Inc. closed a $33 million series B funding round that it plans to immediately use to pursue two clinical trials to evaluate the use of its Neural Ice nerve block for knee pain. The injectable product received U.S. FDA breakthrough device designation in October.
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Recor Medicaal Paradise renal denervation catheter
EuroPCR 2024

Renal denervation, no more excuses to adoption

May 15, 2024
By Shani Alexander
There should be no more excuses to the adoption of renal denervation (RDN) as a treatment for hypertension given the recent approval by the U.S. FDA of two technologies and a range of guidelines recommending the therapy, delegates heard at the EuroPCR conference in Paris. In a discussion on the technology, panelists argued that on the back of solid evidence, RDN should be offered as a treatment given that the therapy is a safe method to reduce high blood pressure.
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