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BioWorld - Friday, December 26, 2025
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Dec. 12, 2017

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FDA eyes formal use of standards for 510(k) filings

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Indian regulators report plan to review and revise coronary stent price caps

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U.S. startup wins Canadian kudos for device to treat MR

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Appointments and advancements

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Financings

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Product briefs

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Regulatory front

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BioWorld Medtech's Cardiology Extra

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Intersect's Sinuva implant earns approval, will be regulated as pharmaceutical product

Intersect Ent Inc. has received approval from the FDA for its Sinuva sinus implant, a targeted approach to treating recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery. Upon news of the approval, shares of the Menlo Park, Calif.-based company (NASDAQ:XENT) jumped 15 percent, closing at $32.75. The implant is being regulated as a drug, marking Intersect's first full-fledge foray into the pharma industry. Read More

Setpoint wins IDE for RA study of VNS device

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