An FDA advisory panel recommends that CryoLife's heart valve, the CryoValve allograft, be subject to its most-stringent pre-market approval protocol.
CryoLife names former Medtronic executive Pat Mackin as its new president & CEO.
CryoLife says it's in line for a $15 million payout due to its stake in Medafor, which C.R. Bard bought last week for some $280 million.
CryoLife Inc. (NYSE:CRY) said it's in line for a $15.1 million payout from the C.R. Bard (NYSE:BCR) acquisition of Minnesota-based Medafor for up to $280 million.
Hansen Medical inks an equity financing deal worth $93 million, sending share prices for the robotic surgery company up nearly 20% today.
Hansen Medical (NSDQ:HNSN) said it inked an equity financing deal for up to $93 million with a consortium of investors including Oracle Investment Management and private equity player Jack Schuler, a co-founder of Crabtree Partners.
The FDA grants pre-market approval for CryoLife's Sologrip laser fiber optic delivery handset, used during surgery for inoperable heart conditions.
Vascular surgical device maker CryoLife announced a regulatory green light today with the FDA's pre-market approval of its Sologrip laser fiber optic delivery system.
Sologrip is a disposable handset designed to be used during surgery to support a relatively new procedure called transmyocardial revascularization approved by the FDA to treat difficult heart conditions.
CryoLife announces a European regulatory win for its HeRo Graft and says the 1st patients will be treated next month.
Medical device maker CryoLife won European regulatory approval for its HeRo graft system, the win coming on the heels of a FDA clearance for HeRo's next generation adapter. Atlanta, Ga.-based CryoLife said a staged product roll-out in Europe will begin next month.
FDA regulators gave the green light to CryoLife’s next-generation HeRO hemodialysis access system.
The FDA granted 510(k) clearance for CryoLife's next-generation HeRO system in treatment of patients undergoing hemodialysis, the company announced.
The new HeRO device includes an adaptor so that it can connect CryoLife's proprietary venous outflow to other dialysis grafts, including early access grafts, the company reported.