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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BTL Industries, Telix, Zeiss Medical.
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.
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.
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.
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.