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BioWorld - Thursday, December 18, 2025
Home » Newsletters » BioWorld MedTech

BioWorld MedTech

April 20, 2018

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Sientra looks to regain market share following approval of PMA supplement

Santa Barbara, Calif.-based Sientra Inc. (NASDAQ: SIEN) scored a big win this week, with the company reporting after the market closed Wednesday that the FDA had approved a final process enhancement for a manufacturing facility. As a result, Sientra is poising to regain market share with its Opus-branded breast implant products and ending an ordeal spawned by an inspection of a contract manufacturer in Brazil. Sientra closed at $11.98 Thursday after closing at $11.05 the previous day. Read More

Avita's Recell spray-on-skin device meets primary endpoints in two pivotal trials

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Speedx wins FDA clearance for M. genitalium, drug resistant STI, testing kit

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Picky trial designs may miss data needed for real-world application

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Pay-and-chase back in play in new OIG report on telehealth

Medicare coverage of telehealth, which is critical for many patients with implanted cardiac electrophysiology devices, has been slow in coming, but a new report on Medicare payments for telehealth recommends that the CMS review paid claims to claw back some instances of overpayment, which would constitute yet another example of the pay-and-chase paradigm that has drawn criticism in the past. Read More

Appointments and advancements

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Financings

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Regulatory front

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Product briefs

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Other news to note

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BioWorld MedTech's Diagnostics Extra

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