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 don't 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...

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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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.

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July 27th, 2015
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St. Jude Medical's Portico

St. Jude Medical's Portico transcatheter aortic valve is a repositionable, retrievable implant that has had CE Mark since .

Portico received CE Mark for its 23 mm size in November 2012 and for its 25 mm size in December 2013. The valve is being studied in a U.S. pivotal trial for FDA approval.

In September 2014, both commercial and trial implants were halted to investigate what was thought to be unusual reduced mobility of the...

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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Abbott's FreeStyle Libre Flash Glucose Monitoring System

Abbott's FreeStyle Libre Flash Glucose Monitoring System allows patients to measure their blood glucose levels without fingerpricks or test strips. The system consists of a small sensor that is worn on the back of the arm for as long as 14 days and a reader.

The sensor has what the company describes as a "small filament" that is inserted into the arm and measures blood glucose levels in the interstitial fluid. A reader is passed over the sensor to give the patient a real-time glucose reading in less than a second. 

The Libre Flash...

July 27th, 2015
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Endologix's Nellix

Endologix developed the Nellix endovascular aneurysm sealing system to give a minimally invasive option to patients who cannot receive conventional endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs). These patients may have challenging aortic anatomy that does not fit traditional EVAR devices. 

The Nellix system uses polymer-filled endobags to seal off the aortic aneurysm and prevent further aneurysm expansion or rupture.

Nellix received CE Mark in January 2013 and has been much buzzed about at vascular medical meetings ever since. Analysts expect Nellix to gain FDA approval...

July 27th, 2015
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Thoratec's HeartMate PHP

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Thoratec's HeartMate PHP is a heart pump intended for hemodynamic support in high-risk percutaneous coronary intervention (PCI) patients. HeartMate PHP received CE Mark in July 2015 but does not yet have FDA approval.

The SHIELD II U.S. pivotal trial is to be conducted in patients undergoing high-risk PCI to support an FDA approval. The randomized trial pits HeartMate PHP against Abiomed's Impella 2.5, which has FDA approval and is the only direct competitor.

Analysts expect HeartMate PHP could receive FDA approval in 2018. 

July 27th, 2015
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Abbott's Absorb

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Abbott's Absorb Bioresorbable Vascular Scaffold (BVS) is a drug-eluting device that is used in angioplasty to open a narrowed coronary artery. The scaffold dissolves after about two years, so patients no longer have a foreign device in their arteries.

When it received CE Mark back in January 2011, Absorb was the first drug-eluting BVS to be approved. Since then, iterations on the platform have been approved—most recently, the Absorb GT1 with the GlideTrack catheter received CE Mark in May 2015. Abbott recently filed a U.S. submission for FDA approval of Absorb.

July 27th, 2015
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