Mislabeled patient death reports can go missed by FDA, potentially leading to unsafe devices remaining on the market, a researcher noted. The analysis raises questions about the complex and often opaque reporting system.
Kevin Lobo said the uncertainty is "baked in" to the company's forecast, though some analysts noted coronavirus variants cloud the outlook for the rest of the year.
Second-quarter results from Abbott Laboratories, J&J and Intuitive Surgical offer encouragement for the rest of the medtech reporting season, according to BofA Securities analysts. They also expect a "small beat" for Dexcom.
CEO Frans van Houten downplayed the potential of a significant impact on Philips' business. But, Baird analysts contend the company could lose about $800 million in the 12-month repair/replace cycle, with ResMed benefiting.
Hillrom CEO John Groetelaars in a Friday earnings call highlighted the growing importance of connected care, the focus area of Baxter's current M&A strategy. A Baird analyst said it sounded like a non-specific defense of a deal.
Second-quarter results reflect the return of elective procedures to pre-pandemic levels. A standout was its pharmaceutical diagnostics business which saw orders grow nearly 50% organically year over year.
Medical device companies are poised to achieve clinical, regulatory, and commercial success with greater efficiencies and cost savings with help from new tech.
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