Category: Cardiovascular Systems Inc.Syndicate content

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

Boston Scientific's peripherals buy bad news for Cardiovascular Systems? | Medtech Wall Street news for the week of May 19, 2014

May 22, 2014 by MassDevice

Here's a look at some of the top Wall Street stories for medical device companies this week: Is Boston Scientific's peripherals buy bad news for Cardiovascular Systems?; M&A: Medtech makers use acquisitions to fill niches; Report: Deals in the medical device sector rose 200% in Q1; CareFusion plans $1B debt offering; Activist investor Oracle revives proxy war at Biolase.

Is Boston Scientific's peripherals buy bad news for Cardiovascular Systems?

May 15, 2014 by Arezu Sarvestani

Is Boston Scientific's peripherals buy bad news for Cardiovascular Systems?

MDT owes $15.4 million to bone cement maker Pabban Development | Medtech legal news for the week of May 19, 2014

May 19, 2014 by MassDevice

Here's a look at some of the top legal news stories for medical device companies this week: Jury: Medtronic owes bone cement acquisition $15M; North Carolina DA probes Cardiovascular Devices; Negligence claims stand in Medtronic Infuse lawsuits; Judge slaps sanction on J&J's lawyers in Ethicon pelvic mesh case; Stryker must face class action employment claims.

Jury: Medtronic owes bone cement acquisition $15M

May 12, 2014 by Brad Perriello

Jury: Medtronic owes bone cement acquisition $15M

Is Boston Scientific's peripherals buy bad news for Cardiovascular Systems?

May 15, 2014 by Arezu Sarvestani

Cardiovascular Systems' shares drop as Boston Scientific positions itself as a peripherals market rival with the $415 million acquisition of Bayer AG's interventional business.

Is Boston Scientific's peripherals buy bad news for Cardiovascular Systems?

Boston Scientific's (NYSE:BSX) $415 million acquisition of Bayer AG's interventional unit is a strong move for the company, but it may bode ill for other peripheral players.

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North Carolina DA probes Cardiovascular Devices

May 12, 2014 by Brad Perriello

The district attorney for western North Carolina investigates Cardiovascular Systems for possible violations of the False Claims Act.

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Cardiovascular Systems (NSDQ:CSII) late last week became the latest medical device company to reveal a federal probe into possible marketing or False Claims Act violations.

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