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.
| Experts in digital health and IVD discuss how medtech is evolving through wearables, AI and regulation.
| 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. | | From Our Library Playbook PA Consulting Group |
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