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HeartWare Pipeline Update: HVAD On Track For 2012 PMA Approval

Firm notes that it has not yet heard from FDA on whether an advisory committee review will be required for its left ventricular assist device, intended as a bridge to transplant.

HeartWare International Inc. is aiming for PMA approval of its first left ventricular assist device by later this year, the company told analysts during a Jan. 9 session of the JP Morgan Healthcare Conference in San Francisco.

HeartWare had previously anticipated an FDA advisory panel review of its flagship HVAD pump by the end of 2011, and...

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Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
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BD Sees $90M Tariff Hit In Q4; 2026 Impact Reduced To $275M

 
• By Shubham Singh

BD raised its adjusted earnings per share guidance midpoint by $0.18 to a range of $14.30 to $14.45, representing growth of about 9.4% at the midpoint – an increase of approximately 1.4% over prior guidance.

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Brazil’s Medtechs Look To Solutions After 50% US Tariff Hit Amid ‘Scenario Of Uncertainty’

 
• By Bernard Murphy

Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.