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PAD: FDA clears new orbital atherectomy device from Cardiovascular Systems

April 21, 2015 by Mark Hollmer

Cardiovascular Systems wins FDA clearance for another iteration of its Diamondback 360 orbital atherectomy device for treating peripheral artery disease.

FDA clears new orbital atherectomy device from Cardiovascular Systems

Cardiovascular Systems closes enrollment in Japan arm of atherectomy trial

December 1, 2014 by Brad Perriello

Cardiovascular Systems says it closed enrollment in the Japanese arm of its coronary orbital atherectomy system trial.

Cardiovascular Systems closes enrollment in Japan arm of atherectomy trial

FDA approves 'artificial pancreas' algorithm for continuous glucose monitor | Regulatory news for the week of November 10, 2014

November 11, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: Diabetes: FDA OKs new 'artificial pancreas' software for DexCom glucose meter; FDA: Edap's Ablatherm prostate cancer device 'not approvable'; Cardiovascular Systems wins CE Mark for Stealth 360 peripheral artery device

Diabetes: FDA OKs new 'artificial pancreas' software for DexCom glucose meter

November 6, 2014 by Brad Perriello

Cardiovascular Systems wins CE Mark for Stealth 360 peripheral artery device

November 5, 2014 by Val Kennedy

Cardiovascular Systems says it won CE Mark approval in the European Union for its Stealth 360 orbital atherectomy system for treating severe peripheral artery disease.

Cardiovascular Systems wins CE Mark for Stealth 360 peripheral artery device

FDA grants Philips clearance for 3D TAVI software | Regulatory news for the week of August 25, 2014

August 26, 2014 by MassDevice

Here's a look at some of the top regulatory stories for medical device companies this week: Philips wins FDA nod for 3D TAVI planning software; Direct Flow wins CE Marks for TAVI device; FDA OKs return of Covidien's Pipeline embolism device; FDA delays UDI rule for contacts, intraocular lenses; Cardiovascular Systems recalls some Diamondback devices on embolism risk

Philips wins FDA nod for 3D TAVI planning software

August 21, 2014 by Brad Perriello

Cardiovascular Systems recalls some Diamondback devices on embolism risk

August 19, 2014 by Brad Perriello

Cardiovascular Systems recalls some of its Diamondback 360 orbital atherectomy devices on the risk that a component could fracture during the procedure, possibly causing an embolism.

Cardiovascular Systems recalls some Diamondback devices on embolism risk

Cardiovascular Systems launches COAST heart disease study

June 12, 2014 by Arezu Sarvestani

Cardiovascular Systems begins enrollment in its COAST trial, evaluating the micro crown Orbital Atherectomy System in patients with hard-to-treat coronary artery disease.

Cardiovascular Systems launches COAST heart disease study