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BioWorld - Sunday, June 15, 2025
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
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Product recall concept image

FDA rapidly lists raft of class I device recalls

June 6, 2025
By Mark McCarty
The U.S. FDA posted notice of six class I device recalls between June 3 and June 5, 2025, four of which are for corrections.
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Appointments and advancements June 6, 2025

June 6, 2025
New hires and promotions in the med-tech industry, including: Angle.
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Financings for June 6, 2025

June 6, 2025
Med-tech firms raising money in public or private financings, including: Accuray, Nanalysis Scientific.
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In the clinic for June 6, 2025

June 6, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Autonomous Medical Devices, Avita Medical.
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Other news to note for June 6, 2025

June 6, 2025
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Histosonics, Lex Diagnostics, Paragon Renault, Treace Medical, Venus Concept, Wandercraft, Zimmer Biomet.
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Regulatory actions for June 6, 2025

June 6, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BTL Industries, Telix, Zeiss Medical.
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Knee pain illustration

Allay’s $57.5M extends postsurgical pain relief with ATX-101

June 6, 2025
By Karen Carey
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As it advances its nonopioid analgesic ATX-101 breakthrough therapy through a phase IIb registration trial, Allay Therapeutics secured $57.5 million in a series D round, which included an investment from the company’s Japanese partner. ATX-101, a configuration of sodium ion channel blocker bupivacaine and a biopolymer, which is in a phase IIb registration study, is designed to offer pain relief following total knee arthroplasty.
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White puzzle pieces on blue background

Highridge sells bone healing business to Avista

June 5, 2025
By Annette Boyle
In the midst of June’s peak wedding season, Highridge Medical LLC called it splitsville – selling its bone healing division to Avista Healthcare Partners. The latest separation continues the sundering of what Zimmer Biomet Holdings Inc. so carefully joined together a decade ago.
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ETH Zurich Menstruai

Menstrual blood-based device detects disease biomarkers

June 5, 2025
By Shani Alexander
Researchers at ETH Zürich developed Menstruai, a device that detects in menstruation blood biomarkers associated with certain diseases. Menstruai uses a sensor built into a sanitary pad and changes color if certain biomarkers are present. The first of its kind technology has the potential to enable the early detection of diseases and transform women’s health care.
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Laptop displaying FDA logo

FDA’s device center playing guidance catch-up

June 5, 2025
By Mark McCarty
The U.S. FDA’s Center for Devices and Radiological Health is recovering from a guidance drought that spanned several months in the first part of calendar year 2025, starting with a guidance on the Q-sub process.
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