Federal authorities doled out prison time and fines to former executives of spinal fixation firm Synthes, and sent a broader warning to everyone in the industry about the penalties of corporate non-compliance for individuals.
To gain some perspective on the current state of focused ultrasound research, Medtech Insight interviews Neal F. Kassell, MD, Chairman of the Focused Ultrasound Surgery Foundation and Distinguished Professor of Neurosurgery at the University of Virginia. Kassell outlines some of the successes and remaining challenges in this field, discusses research efforts supported by the Foundation, and provides his perspective on the wide-ranging impact this technology could have on future treatment paradigms across multiple specialties.
Intra-articular injections of hyaluronic acid, which mimics the lubricating properties of natural synovial fluid and lessens friction and pain in the osteoarthritic knee joint, has become increasingly popular for treating osteoarthritis. However, of the seven formulations available in the US, none have been proven clinically superior and they have only limited long-term benefit to the patient. Flex Biomedical Inc. is working to address these concerns with a single-injection synthetic polymer alternative to HA.
There has been a tendency in the health care products industries to design products that serve the maximum number of patients, in order to create the biggest markets. In pursuit of that all inclusive goal, medical device companies have often overengineered products, adding features - and costs - not necessary for the majority of patients. This has been the case in the field of arrhythmia monitoring. By challenging previous assumptions about arrhythmia monitoring, iRhythm believes it's developed a device that improves the diagnostic efficiency and ultimately the economics of arrhythmia care.
The Medicare agency plans to launch a demonstration project next year on prepayment review and prior authorization of power mobility devices, but it faces resistance from industry trade group AAHomecare.
Research into the use of image-guided focused ultrasound (IgFUS) as a noninvasive therapeutic modality is starting to achieve the kind of critical mass - in clinical outcomes data and R&D investment - necessary to win the interest and support of clinicians, payors, and regulators. Although there is still a good distance to travel before the technology achieves a routine place in the therapeutic toolkit, IgFUS is clearly an up-and-coming field in the medical device arena, and many believe it has the potential to revolutionize the treatment paradigm in a number of clinical areas.
Acute ischemic stroke used to be a device category that promised a slow but certain death for start-ups. But there's lots of life in the market, as evidenced by a recent wave of consolidation. Meanwhile, hemorrhagic stroke companies have been perfecting the treatment of cerebral aneurysms.
Despite the recent downturn in the national economy, Ireland's medical device community is on the verge of a major growth spurt. A lot of the credit goes to strong government support, particularly in the form of Enterprise Ireland, which serves as a major investor in medtech start-ups. Even with such support, Ireland's medtech start-up community faces many of the challenges that any start-up community faces. But the sector has high hopes and great ambitions. The second of a two-part series.
New FDA guidances aim to strike a balance by allowing firms to begin trials earlier through adaptive study designs, while ensuring that patients are adequately protected.
Although the spine market appears to be stabilizing to some extent, the vertebral compression fracture market continues to be challenged by reimbursement issues and lingering controversy stemming from the New England Journal of Medicine articles questioning the efficacy of vertebroplasty and vertebral augmentation as a treatment for VCFs.
