The question of the U.S. FDA’s authority to regulate lab-developed tests (LDTs) has been percolating for more than a decade, but the recent failure of Congress to pass legislation granting the agency explicit authority to do so is seen in some quarters as a missed opportunity. The FDA’s Elizabeth Hillebrenner said that while the agency would prefer to regulate LDTs under new statutory authorities, the agency sees a public health problem with the current state of affairs, and thus, “we are moving forward with rulemaking.” Read More
Theranica Bio-Electronics Ltd. broadened its U.S. FDA clearances for the Nerivio prescription wearable to include migraine prevention in individuals with or without aura. The remote electrical neuromodulation (REN) device offers an alternative to the significant population of migraine patients who do not respond to or cannot tolerate prescription drugs that treat the condition. Read More
Eko Devices Inc. launched a new platform designed to easily identify heart and vascular problems. The artificial intelligence (AI)-driven Sensora cardiac disease detection platform currently features an algorithm that detects structural murmurs and another to guide patient care through the health care system. Read More
Europe has given device makers more time to meet requirements set out in the 2017 Medical Devices Regulation (MDR). The European Parliament approved in mid-February an extension of the transition periods for medical device and IVD manufacturers to comply with the new rules, which aim to enhance safety for patients and ensure the “smooth functioning of the internal market.” Read More
Hemerion Therapeutics SAS presented its newest Heliance diffuser, part of its technology to treat glioblastoma during neurosurgery procedures. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Konica Minolta Healthcare, Otsuka Medical, Recor Medical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Artiq, Clario, Devyser, Eresearchtechnology, GE Healthcare, Mprobe, Novocure, Paragon Genomics, Positron, Prophase Labs, Qiagen, Sophia Genetics, Surgalign, Xtant Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Spectrawave, Theranica. Read More
