With recent changes to US patent laws, a landmark US Supreme Court decision, and the emergence of so-called “patent trolls” in the medical device community, it seems everyone is talking patents. Medical device patents and litigation are “booming,” according to industry experts, and medtech companies need to pay close attention.
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Cibiem Inc.’s catheter-based CBM system is designed to modulate the carotid body, a tiny group of chemoreceptors located at the fork of the carotid artery that helps regulate respiratory activity. The start-up believes its technology could mean new treatment possibilities for a broad range of diseases including heart failure, where it could address the remodeling that takes place as well as alleviate such symptoms as breathlessness.
Much of the innovation in spine over the past decade has aimed at replacing fusion, the standard of care. SpineGuard’s novel sensor technology is betting on fusion’s long-term prospects, helping patients and surgeons by making the procedure safer.
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August 26, 2013
CDRH’s Shuren Signals More Guidance, Enhanced Pre-Market Payer Role
In an interview, CDRH Director Jeffrey Shuren detailed plans for new guidance documents and process changes at the device center focused on IDE reviews, clinical testing requirements and pre-submission interactions with payers based on recommendations from the center’s entrepreneurs-in-residence program.
Studies suggest transcatheter aortic valve replacement is associated with a higher stroke risk than standard surgical valve replacement, presumably due to embolic debris released during the TAVR procedure. To address this concern, several companies are developing TAVR-specific embolic protection devices, and their success may prove to be a key driver of future growth in this $1+ billion market.
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LoneStar Heart's injectable biopolymer Algisyl-LVR represents a new advanced HF treatment strategy based on a medically accepted principle that a reduction in muscle tension and wall stress of the dilated heart will improve its function. The company, which originally envisioned Algisyl-LVR as a carrier for targeted delivery of biologics, drugs, or stem cells, discovered in animal studies that use of the biopolymer by itself had a profound effect on improving the mechanics of the heart.
GE’s healthymagination has evolved from an initiative focused on marketing, brand, and thought leadership activities into a significant, internally integrated corporate venture function around health care. But whether nimble, out-of-the-box thinking and a VC-like function can thrive inside a massive organization remains to be seen.
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August 19, 2013
Lawmakers Press OMB To Release Lab-Developed Test Draft Guidance
In a letter to Office of Management and Budget director Sylvia Mathews, nine Democratic representatives urged the release of a draft guidance establishing an FDA oversight structure for laboratory-developed tests. FDA said more than a year ago that the documents were under administrative review.
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While the PSA test is still widely recognized as a valuable prostate cancer screening tool, its dismal accuracy record has created an acute need for more effective and informative alternatives, and the field of molecular diagnostics, based on gene-based biomarkers, is leading the charge.
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Ventricular assist devices are a viable long-term treatment option for patients with advanced heart failure, but their exorbitant price tag and their propensity to damage blood has limited their use. Calon Cardio-Technology Ltd. hopes to avoid those problems with its MiniVAD, which is similar in size and weight to the smallest existing VADs, but is designed to be more efficient and process blood flow more gently.
