Medtronic plc guided investors’ expectations lower for the balance of its fiscal year, citing pummeling from foreign exchange rates, continued delays in elective procedures and ongoing supply chain issues. In response, the stock (NYSE:MDT) dropped from its close at $82.43 on Monday to open at $76.91 Tuesday. The company reported $7.59 billion in revenue for the first half of its fiscal 2023. That represented a 3% drop on a year-over-year basis, missing consensus expectations of $7.7 billion, in part because of a $457 million foreign currency hit. Read More
The companion diagnostic (CDx) has been a mainstay of oncology care for several years, but Richard Pazdur, director of the U.S. FDA’s Oncology Center of Excellence (OCE), said recently in a public forum recently that the notion of a single CDx for an investigational drug has not served patients well. Pazdur said OCE and the FDA’s Center for Devices and Radiological Health are working on a pilot program that would entail the publication of performance standards for the tests used in these trials, a development that would lead to more routine development of lab-developed tests (LDTs) for these studies and thus undercut any incentive to develop a patented in vitro diagnostic for that purpose. Read More
Jiangsu Bioda Life Science Co. Ltd.’s artificial blood vessel has gained class III medical devices approval from China’s NMPA, marking the first domestic artificial blood vessel to get such approval. Nantong, China-based Bioda’s vessel is used for aortic coarctation and aneurysms. Read More
Mdoloris Medical Systems SAS and Pprs SAS reported a joint venture to launch ANI Guardian, a connected medical device that continuously and non-invasively tracks pain levels and well-being in a range of non-verbal or cognitively impaired people. Read More
As IPOs have slowed significantly in 2022, so have the debuts of special purpose acquisition companies (SPACs) targeting the life sciences industry, primarily due to two looming threats. This time a year ago, BioWorld had tracked 60 IPOs of SPACs searching for biopharma or med-tech targets and nearly 30 SPACs that had secured acquisitions. For 2022, there are 21 SPACs currently searching, and only two of those went public this year. As for completed M&As involving SPACs, there have been 17 this year and another nine that are pending. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocare Medical, Eisai, Empire Genomics, GE Healthcare, Innerscope Hearing, Innovimed, Inspira, Shimadzu. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accure Acne. Read More
