Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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Pre-market approval from the FDA in hand, CardioFocus is readying for a coming-out ball of sorts for its HeartLight cardiac visualization and ablation device at this week’s annual meeting of the Heart Rhythm Society in San Francisco.
Chairman Paul LaViolette told MassDevice.com that Marlborough, Mass.-based CardioFocus is planning a selective U.S. launch for HeartLight starting in July. The device combines a balloon dilation catheter with a laser-based micro-endoscope and ablation device to allow electrophysiologists to see the tissue they’re targeting for ablation. Read more
Valeritas said today it raised $25 million through an “alternative public offering” via a reverse merger and the private placement of 5 million shares of unregistered stock at $5 per share.
Through the reverse merger, Valeritas will trade on the OTC market under the symbol “VLRX” and will continue to operate business as usual, the Bridgewater, N.J.-based company said. Read more
Shares prices for HeartWare International plunged this morning after the implantable heart pump maker posted 1st-quarter earnings that badly missed expectations on Wall Street.
Framingham, Mass.-based HeartWare reported that losses widened 20.1% to -$17.5 million, or -$1 per share, on a -21.3% revenue slide to $55.1 million. Adjusted to exclude 1-time items, losses per share were -95¢, -16¢ off the forecast on The Street, where analysts were looking for sales of $59.9 million. Read more
Boston Scientific said today that it won pre-market approval from the FDA for a pair of ablation catheters that use the 3D cardiac mapping technology it bought from Rhythmia Medical back in 2012.
Marlborough, Mass.-based Boston Scientific said the federal safety watchdog gave the green light to its IntellaNav XP and IntellaNav MiFi XP mapping and ablation catheters for treating Type I atrial flutter. Read more
Medtronic today confirmed that it’s hiring a new finance chief from financial services company Comerica after the upcoming retirement of longtime CFO Gary Ellis.
The Fridley, Minn.-based medical device leviathan said it tapped Karen Parkhill, Comerica’s CFO, to replace Ellis, as initially reported this morning by the Wall Street Journal. Medtronic said Ellis is slated to step down as CFO June 20 after a 27-year run with the company, but will retain oversight of the company’s global operations, IT and facilities & real estate doings. Ellis, who served as CFO for 11 years, is also slated to keep his seat on Medtronic’s executive committee. Read more