New research findings presented at a joint meeting of FDA’s gastroenterology and radiological devices panels persuaded experts that CT colonography is safe and works well for screening adults over 50 for colorectal cancer.
Intermountain Healthcare, a Utah-based nonprofit hospital system, has teamed up with six leading information technology companies to launch the Healthcare Transformation Lab, a project aimed at helping foster the development and commercialization of innovative new technologies with the potential to improve patient care and provider efficiency.
A $50 million venture fund set up by pharmaceutical giant GlaxoSmithKline has chosen vagus nerve stimulation device start-up SetPoint Medical, a company currently focused on treatments for autoimmune diseases, as its first investment. The move highlights the growing importance of device-mediated therapies for a wide range of common, chronic conditions.
Deep brain stimulation (DBS) currently comprises only about a quarter of the worldwide neuromodulation device market, but growth in this segment is strong. Both large and small competitors have targeted DBS, which has the potential to address a number of highly prevalent and underserved diseases and disorders.
The market for insulin delivery devices is positioned to change significantly with several manufacturers gearing their products toward type 2 diabetics, who make up 90% to 95% of the diabetes patient pool in the US. These new, “pump-like” devices could offer the type 2 diabetes population better control in managing glucose levels, a solution the medical community has been seeking for a while.
The spine device firm LDR filed to raise up to $69 million in an initial public offering just as it gained FDA approval for its Mobi-C cervical disc for one- and two-level indications. Device investors will keep a close watch on the IPO, as one has not been staged by a venture-backed spine start-up since 2007.
An estimated 15 million Americans have obstructive sleep apnea severe enough to warrant treatment, but this field has been chronically underserved by traditional continuous positive airway pressure systems that are inconvenient and uncomfortable to use. To address this problem, CPAP manufacturers are making design improvements to optimize comfort and compliance; at the same time, promising new technologies are emerging – including neurostimulation devices for OSA – that could help reshape the future management of this often overlooked, but serious disorder.
Advances in imaging and interventional endoscopy are improving cancer detection and enabling less invasive approaches to diagnose and treat disorders in the gastrointestinal tract. These emerging procedures are poised to fuel growth in the $7 billion global market for GI endoscopy.
Novel arrhythmia mapping technologies, once they are clinically proven and validated, could change practice paradigms in the atrial fibrillation ablation space but in the meantime work continues on nearer-term advances that could make AF ablation more effective and durable. Three of the most promising – contact force sensing, endoscopic laser ablation, and atrial fibrosis imaging, from such companies as Endosense, Biosense Webster, CardioFocus, and Marrek – have recently achieved some important milestones in their journeys toward US market approval.
Groundbreaking new mapping technologies could shift the future direction of the $2.5 billion AF ablation market, as evidenced by presentations at this year’s HRS and EUROPACE meetings; with some compelling clinical data now on the books, the electrophysiologists who perform AF ablation are taking notice, as are investors and strategics operating in this space. Emerging companies at the heart of this shift include Topera Medical, CardioInsight Technologies, and Acutus Medical.