Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sofwave Medical, Solo Pace.
Nearly three weeks into the job, U.S. FDA Commissioner Marty Makary provided a comprehensive overview of his vision for the much-reduced agency, even as he’s taking first steps to implement his agenda.
First quarter earnings reports from Johnson & Johnson and Abbott Laboratories provided some surprising insights into the likely hit med-tech companies will sustain with current tariffs. The main takeaway? The impact of the trade war with China is far greater than expected by most analysts.
The U.S. Centers for Medicare & Medicaid Services decided to peel back a series of local coverage determinations for skin substitute grafts that provoked a vigorous response from stakeholders.
The U.K. National Institute for Health and Care Excellence (NICE) gave the nod to a total of 11 robotic surgical systems for use in the U.K.’s trusts, but this is no free pass as the agency expects the manufacturers of these systems to gather data under this conditional coverage framework.
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