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FDA OKs expanded label for InSightec's noninvasive ultrasound fibroid device

The FDA has signed off on Israeli devicemaker InSightec's ultrasound technology to treat women with uterine fibroids who want to conceive, a win for the company as it pushes for new indications of its product and reels in funding to spur R&D.

Harvard's Wyss launches Opsonix, backed by Baxter in $8M round to get sepsis device into clinic

The Wyss Institute for Biologically Inspired Engineering at Harvard University has launched startup Opsonix to develop its pathogen-extracting, extracorporeal sepsis device. Hansjörg Wyss, who founded the Institute with a $125 million gift in 2008, also participated in an $8 million Series A round that was led by Baxter Ventures.

Boston Scientific tests the waters with a remote patient monitoring innovation challenge

Remote patient monitoring isn't a core business for Boston Scientific, but it is looking to gain access to the most cutting-edge tech in the field. It's launched the Boston Scientific Connected Patient Challenge: an open innovation challenge to solicit ideas and collaborations for remote patient monitoring.

Feds reject whistleblower's complaint about unsafe imaging devices

The feds rejected a whistleblower's complaints that the FDA erred when it approved imaging devices for breast and colon cancer screening.

Boston Scientific gets the first (partially) bioabsorbable stent to FDA approval

The FDA just approved its first third-generation bioabsorbable stent, to the delight of Boston Scientific.