Ledger.

Startup · $32m raised

sunshineHeart

Sydney, NSW

Coverage

Stories naming sunshineHeart. Where several outlets covered the same round, they are bundled under whichever ran the fullest account.

News

Sunshine Heart - First Female Patients in US Implanted with C-Pulse

Sunshine Heart announces that two female patients at Louisville's Jewish Hospital are the first US women implanted with its C-Pulse heart assist system in an FDA-approved 20-patient feasibility trial.

News

Sunshine Heart - First U.S. C-Pulse Implants

Sunshine Heart reports the first two US implants of its C-Pulse heart assist device, performed at Ohio State under a 20-patient FDA-approved feasibility trial running across six American hospitals.

News

FDA Grants Full Approval of US Clinical Trial

Sunshine Heart won complete US regulator clearance to run its first American trial of the C-Pulse heart device, having satisfied conditions attached to September's conditional clearance; enrolment of trial participants was anticipated that year.

News

FDA Approves Reimbursement Category for C-Pulse

Sunshine Heart says the US FDA approved a reimbursement category for its C-Pulse heart assist trial, opening Medicare reimbursement; it retained Quorum Consulting and expects patient enrollment at six US institutions in late 2008.

News

FDA Approval for C-Pulse US Clinical Trial

Sunshine Heart says the US regulator has conditionally cleared its first American trial of the C-Pulse heart assist device, with about twenty patients to enrol across six US hospitals from late 2008.

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