Inside traders draw jail time in Stryker case
ReGen Biologics appeals loss to FDA
ReGen Biologics’ long battle against the FDA entered a new phase this year, with the medical device company’s appeal in a lawsuit it filed against the watchdog agency, its top regulator and the secretary of the U.S. Health & Human Services Dept. over the FDA’s decision to rescind the clearance granted to ReGen’s Menaflex knee implant.
Analogic wins FDA clearance for handheld Sonic Window vascular ultrasound
Medtronic wins CE Mark for Evera MRI SureScan ICD
Medtronic (NYSE:MDT) said it won CE Mark approval in the European Union for the world’s 1st market-cleared implantable cardiac defibrillator that’s safe for full-body magnetic resonance imaging scans, its Evera MRI SureScan ICD.
The Evera device is slated for an immediate launch in Europe, according to a press release.
Sequent Medical raises $20M Series D for brain aneurysm device
Sequent Medical said it raised a Series D round worth $20 million from its slate of previous investors, led again by Delphi Ventures.
Domain Associates, US Venture Partners and Versant Ventures also participated, Sequent said.
Abiomed wins CE Mark for Impella RP heart pump
Deerfield raises $1.6B healthcare fund
Deerfield Management Co. said it raised a fund aimed at healthcare investments that’s worth $1.6 billion.
Deerfield Private Design Fund III is "designed to provide flexible private financing to healthcare companies," according to a press release.
PAD: Medtronic’s In.Pact Admiral drug-eluting balloon bests Bard’s Lutonix at 6 months
Vital Therapies lowers the bar with 2nd IPO try
Bio-artificial liver maker Vital Therapies set the range for its initial public offering at $13 to $15 per share, below the $16 to $18 range it set last year before scuttling its 1st try at a U.S. IPO.
In March Vital Therapies filed updated registration statements signaling its intent to launch the IPO, wiping clean the pricing set in November 2013. Another filing today set the new price range for the 4.5-million-share offering at $58.5 million to $67.5 million.
Jury splits in $1.2M Ethicon pelvic mesh case
A Dallas jury split its decision in a product liability lawsuit filed over Ethicon’s TVT-O pelvic mesh yesterday, awarding $1.2 million in compensatory damages to plaintiff Linda Batiste.