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Samsung Acquires AI-Powered Prenatal Ultrasound Startup

MedCity News

The startup’s AI platform, which was cleared by the FDA last year, automates ultrasound reporting so that healthcare providers can conduct these exams with greater accuracy and efficiency. Samsung announced its plans to acquire French medtech startup Sonio.

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Takeda yanks FDA filing for dengue vaccine, citing data disagreement with regulator

Fierce Pharma

travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting. | U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting.

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FDA drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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What Pear Therapeutics’ Bankruptcy Has Left the DTX Industry to Ponder

MedCity News

Bringing the very first prescription digital therapeutic (PDT) to market in 2017, Pear Therapeutics went above and beyond to follow suggested regulatory guidelines, obtained Food & Drug Administration (FDA) clearance, and provided solid clinical study evidence.

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US FDA approves Blueprint Medicines’ indolent systemic mastocytosis therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The precision therapy has been designed for potently and selectively inhibiting KIT D816V, which is the main underlying driver of the disease.

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Our healthcare has failed us

World of DTC Marketing

IN SUMMARY: American healthcare is failing. Not only has the FDA become a political pawn but almost half the population is now obese. While there are lots of reasons for this the silence of healthcare providers is a huge reason.

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America’s healthcare costs are in deep crisis

World of DTC Marketing

Healthcare providers make more money treating poor health than preventing it. The FDA could require all pharma product websites to add general health prevention information and links to credible online health information. The explanation of why is actually quite simple. Aye, that’s the question!