HeartWare's CEO strikes an optimistic tone regarding the acquisition of competitor Thoratec by cardiac company St. Jude Medical. 

Marie Thibault

As one of two major players in the left ventricular assist device (LVAD) market, HeartWare has been seen as an acquisition target in the past. In fact, LVAD pioneer and HeartWare competitor Thoratec tried to purchase the company once upon a time. But last week, it was Thoratec, not HeartWare, in the spotlight, when St. Jude Medical announced it plans to buy Thoratec for $3.4 billion, net of...

July 31st, 2015
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In this month alone, Edwards Lifesciences and Abbott have made deals with three mitral valve disease startups underscoring the possibility of a M&A flurry in this market. 

Arundhati Parmar

 

Now that the efficacy of transcatheter aortic valve replacement has been firmly established, companies are turning their focus on another structural heart procedure: transcatheter mitral valve repair or replacement.

And just as acquisitions consolidated the TAVR space - Edwards Lifesciences bought Percutaneous Valve Technologies, Medtronic bought CoreValve and Boston Scientific bought Sadra Medical - it appears as if the market is poised to see a few acquisitions in the TMVR space too.

Earlier this month Edwards Lifesciences announced it was...

July 31st, 2015
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Cognivue aims to catch cognitive decline early with a computer-based test that can be administered by primary care doctors.

Marie Thibault

Some memory loss and slower thinking is an inevitable part of aging—right? When does forgetting a face or misplacing the car keys every once in a while become a reason for concern?

Patients with worries about their cognitive function can visit a neurologist at a major medical center to undergo cognitive assessment. However, there are many patients who live in rural areas or don’t have the ability to travel to a specialist. Are they relegated to trying to self-test their cognition with the daily crossword?

Not anymore. In June, FDA granted de novo approval to the ...

July 30th, 2015
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If you’ll be in San Diego this September 1 and 2, be sure these events make your agenda.

Jamie Hartford

Sunny San Diego will be the hottest place in the medtech universe this September 1–2, when industry luminaries gather at the San Diego Marriot Marquis and Marina for the 2015 MEDevice San Diego Conference and Showcase.

Now in its fifth year, the show features a number of educational and networking opportunities you won’t want to miss. Here are a few we recommend checking out.

Conference Sessions
 

The MEDevice San Diego...

July 29th, 2015
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The new leader at NuVasive discusses the company's interest in potential M&A transactions, particularly outside the United States. 

Marie Thibault

NuVasive's headquarters in San Diego, CA.

NuVasive's new CEO, Gregory Lucier, made no bones about the spine company's interest in acquisitions and the possibility of entering new countries through "inorganic growth." 

On a July 28 earnings call with analysts, Lucier was asked a few times about the company's M&A outlook. According to a SeekingAlpha transcript, Lucier said, "I am indicating to investors that we will begin to be more...

July 29th, 2015
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A corporate investor at Johnson & Johnson shares the company's venture investment philosophy at a time of change in healthcare. 

Arundhati Parmar

Renee Ryan is the vice president of investments at JJDC, the venture arm of Johnson & Johnson. She will be a speaker on the funding panel at MEDevice San Diego, Sept. 2, an event hosted by UBM, which publishes MD+DI.

Recently, in a phone interview, she described JJDC's investing philosophy, what she looks for in device firms and her excitement when she comes across a promising device startup, with cool new technology and headed by a female CEO.

MD+DI: How has JJDC evolved...

July 28th, 2015
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An FDA official gives a concrete example of how the agency decided that clinical trials without a control arm could be used to assess a certain type of device.

Marie Thibault

 

Here's a message to those in the medical device industry who think the FDA regulatory process is too complicated: FDA is already streamlining requirements.

That was the word from Ben Fisher, PhD, director of the Division of Reproductive, Gastro-Renal, and Urological Devices in the Office of Device Evaluation at CDRH. Fisher wrote in a recent FDA Voice blog post that the agency recently determined that it would be possible to evaluate future global...

July 28th, 2015
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Understanding both commercial and on-chip graphics cards will help designers optimize long-term performance.

Martin Rudloff

Arenas like oncology, orthopedics, obstetrics, and cardiology are relying on enhanced imaging technology in all phases of the healthcare spectrum, from clinical research to real-time patient diagnosis and treatment.

Medical imaging is a volatile arena—changing rapidly, filling gaps in medical knowledge and becoming an essential factor in improving patient diagnosis and treatment. Quickly advancing from high-resolution imaging to 3-D volumetric scans, sophisticated graphics are at the core of many new...

July 27th, 2015
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Boston Scientific's Synergy

Boston Scientific's Synergy stent is made with thinner struts and a bioabsorbable polymer coating that dissolves about three months after implantation, with the intention of quicker healing.

Synergy gained CE Mark in October 2012 and has become a popular choice for with European physicians. On a recent earnings call, Boston Scientific executives noted that Synergy makes up 30% of company's drug-eluting stent sales in Europe.

Synergy was the subject of the EVOLVE II U.S. pivotal trial. U.S. patients won't have to wait long . . . the stent is...

July 27th, 2015
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NeoChord's DS1000

NeoChord has developed the DS1000 for minimally-invasive mitral valve repair in patients suffering from severe mitral valve regurgitation.

Transapical transcatheter mitral valve repair with the DS1000 reduces the necessary incision from 3–10 inches to 2–3 inches and allows the procedure to be done off pump, according to information on the NeoChord Web site. This means the patient's heart continues beating during the procedure, as opposed to being stopped and put on cardio-pulmonary bypass.

The DS1000 received CE Mark in December 2012 but does not have FDA approval.

...
July 27th, 2015
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