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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Nov. 26, 2012

View Archived Issues

FDA approves HeartWare VAS as a BTT for end-stage HF

It's been a long road for HeartWare International (Framingham, Massachusetts), but the company's patience and perseverance has finally paid off. The FDA has approved the company's premarket approval application (PMA) for its HeartWare ventricular assist system (VAS) as a bridge-to-transplantation (BTT) therapy for patients with end-stage heart failure. HeartWare submitted the PMA nearly two years ago (Medical Device Daily, Dec. 29, 2010). Read More

Washington roundup: FDA releases long-awaited artificial pancreas guidance

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Report from Europe: Imagine Eyes lands CE Mark for its rtx1 retinal camera

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Tomosynthesis increases diagnostic cancer accuracy

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Agreements/contracts: ARS to use IDS' clinical documentation platforms

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HIT roundup: Karolinska Institute study bolsters Sectra's online service

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RSNA notebook: 3D Systems displays healthcare solutions at RSNA conference

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Patent watch: Medgenics gets protection for Epodure Biopump tech

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Restructuring roundup: Bioventus in plan to launch $5 million expansion project

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Med-Tech Notes

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Product Briefs

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MDD's Neurology Extra

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