Global Device Approvals Snapshot: 25 June-1 July 2019
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 25 June to 1 July was another slow one for approvals, with no new PMAs, panel-track PMA supplements, or de novos. Japan’s MHLW approved Foundation Medicine’s companion diagnostic for Roche’s cancer drug Rozlytrek.
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Roche’s tumor-agnostic drug receives first approval globally in Japan following an expedited review, giving the Swiss group a lead over its rival in this market. But sales may be limited.
Investment firm Francisco Partners will acquire IBM’s Watson Health’s data and analytics assets – including Micromedex, MarketScan, and Clinical Development – for an undisclosed price.
The electrophysiology company announced it will reduce its workforce and take other cost-reduction measures to reduce its annual spending by $23m-$25m. Analysts suspect the company will need to raise more money from investors in 2022 or try to be acquired by a larger company.