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Endologix Inc. is on a path to expanding its Ovation platform through its ELEVATE IDE clinical study. The Irvine, Calif.-based company said the 75-patient trial will evaluate the safety and effectiveness of its Ovation Alto abdominal stent graft system for the repair of infrarenal abdominal aortic aneurysms (AAA). The company said the first patients have already been treated in the trial. Ovation Alto broadens Endologix's reach into the endovascular aortic repair (EVAR) market and provides treatment options for patients with complex AAAs. The device is specifically targeted toward patients with very short or otherwise challenging...
Boston Scientific Corp. will acquire Symetis SA for $435 million in cash in an effort to broaden its transcatheter aortic valve replacement (TAVR) portfolio. The Ecublens, Switzerland-based company had been expected to list publicly at the end of this month on the Euronext Paris market in an offering slated to raise €55.8 million (US$59.9 million). Instead, the Marlborough, Mass., cardiovascular giant has scooped up Symetis, which has two EU marketed TAVRs with a next-gen iteration in the clinic. Wall Street evinced some concern that the addition of Symetis' Acurate platform to Boston Scientific's existing Lotus...
New research published in the BMJ finds that total knee replacement may be most useful in osteoarthritis patients with the most severe symptoms, with little quality of life or economic benefit from the use of the procedure in the less severe patient population. The researchers suggested that a more rigorous assessment for individual patients of the potential risks and benefits of knee replacement, as well as better optimization of more conservative interventions, could help to improve population-level outcomes and the economic utility of the procedure. The study authors call for further research to advance these...
Organogenesis Inc. is set to acquire Nutech Medical Inc. a private company and supplier of tissue products used in spinal and orthopedic surgeries. Financial details surrounding the deal were not disclosed. Canton, Mass.-based Organogenesis has been waiting to enter the amniotic tissue market, which led to it picking up Nutech Medical. "The acquisition expands Organogenesis' product profile into the surgical, orthopedic, spine and amniotic wound care markets and unites two pioneering companies, each with decades of experience in bringing quality biologics products to patients around the world," Gary Gillheeney, president and CEO of Organogenesis, told...
iCAD Inc. has secured a PMA approval from the FDA for the computer-aided detection product for digital breast 3-D tomosynthesis that is based on deep learning. The product is already available via Chicago-based partner GE Healthcare; the Nashua, N.H., start up is working now to make it available to other major tomosynthesis providers. Known as Powerlook Tomo Detection, it received a CE mark and Health Canada approval last year. In Europe, it's already in use at multiple high-volume breast imaging centers. APPLYING DEEP LEARNING "The way the product works is that we have developed a...
Newly published guidelines from the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) support cardiac monitoring devices in evaluating syncope patients. The "2017 ACC/AHA/HRS guideline for the evaluation and management of patients with syncope" was recently published online in the Journal of the American College of Cardiology, Circulation and Heartrhythm. American College of Emergency Physicians and the Society for Academic Emergency Medicine also helped draft the guidelines. The new measures point out the choice of a specific cardiac monitor should be determined on the basis of the...
Biostable Science & Engineering Inc. received FDA clearance for its Haart 300 product, an annuloplasty device designed for aortic valve repair. The Austin, Texas-based company said it will launch the device in select heart centers this summer. The company has had CE mark for the Haart 300 since March 2016. (See Medical Device Daily, March 9, 2016.) Heart valve repair is a procedure to repair native valve function instead of replacing it with a mechanical or biological replacement device. Valve repair may be more durable than biological valve replacement and avoids the complications associated with...
Treatment has begun on the first patients in Origin Inc.'s U.S. dose-ranging GENESIS trial. The Princeton, N.J.-based company has developed a technology to produce and deliver plasma-generated nitric oxide for the treatment of chronic diabetic foot ulcers (DFU). Origin, which was formed in 2010 and was formerly called Advanced Plasma Therapies Inc., has developed a device with a hand-held, computer-guided system that generates nitric oxide from ambient room air within a defined plasma stream. From there, nitric oxide is generated and targeted toward the patients wound for about six to 12 minutes. "From an external...
WASHINGTON – Payers are quite interested in technologies that determine whether a patient really needs an expensive treatment, but fractional flow reserve (FFR) might have to take a back seat to instantaneous wave-free ratio (iFR) for determining the need to revascularize the coronary arteries, according to two presentations at ACC 2017. Among the companies whose fortunes might be affected by any conclusions drawn from these studies is Heartflow, which reported at the 2016 edition of the American College of Cardiology annual meeting that it had wrapped up a study intended to nudge payers off the...
WASHINGTON – The FDA broke an embargoed release of data for Abbott Laboratories' Absorb GT1 scaffold, advising clinicians that the rates of major adverse cardiac events in a large study were higher than seen with the comparator, but leading cardiologists at ACC 2017 were nonetheless unwilling to recommend that clinicians abandon the device. The FDA's safety alert preceded the embargo placed on the news from the Absorb III study – sponsored by the Abbott Park, Ill.-based company – by nearly 50 minutes, but contained no information that was not included in the presentation by Stephen...
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines...
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s...
Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS...
After being in the doldrums for the majority of the year, public biopharmaceutical companies, it appears, have turned the corner and are now on a major upswing.
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