With health care becoming increasingly data driven, third-party payors are requiring a higher level of evidence before making a positive coverage determination for a new technology or procedure. This has made the road to reimbursement much longer and tougher for device companies in general, and manufacturers of transoral devices for GERD are a prime example.
Even with all of the advances and options in heart failure therapy, there remain no real options for a large number of patients who are seriously ill but not yet at the end-stage of the disease. CircuLite hopes to change that with a partial support device for patients who don’t need a VAD.
Topera Medical questions the assumptions underlying current therapies for atrial fibrillation. Sanjiv Narayan, MD, PhD, the electrophysiologist who founded Topera, has developed a means of identifying focal sources of aberrant electrical activity called rotors, and in late breaking clinical trials at the 2013 annual meeting of the Heart Rhythm Society, was able to show a definitive link between their ablation and treatment success.
The agency issued a draft guidance and safety communication last week in response to a recent emergence of cybersecurity breaches occurring in wirelessly connected medical devices in hospitals.
The current technologies for diagnosing spinal disease don’t consistently deliver what’s required of any medical diagnostic: good predictive value, high specificity, sensitivity, validity, reproducibility, and safety. This is a gap that several young, innovative companies have set out to fill.
Robotic-controlled surgical tools – led by market leader MAKO Surgical Inc. – are beginning to take root in the knee surgery market, at least in partial knees. Perhaps the truest measure of the potential of this market is the growing competition that MAKO is facing: just over the past five months, Blue Belt Technologies and Stanmore Implants Worldwide received FDA approval for rival robotic surgical systems.
Large numbers of patients with chronic wounds haven’t responded to existing treatments, and their open wounds can have dire consequences. The suffering of patients, the failures of past remedy attempts, and new financial pressures on hospitals have medtech entrepreneurs and venture investors focused on finding better solutions to wound care.
Medtronic says it reached the necessary trial enrollment to support PMA approval for its IN.PACT Admiral drug-eluting balloon catheter to treat atherosclerosis in the superficial femoral artery. On the same day, CR Bard said it was prepared to submit its final PMA module for its Lutonix drug-eluting balloon by year’s end.
Bioresorbable coronary scaffolds could transform the coronary stenting market once they become widely available. But although there are more than a dozen companies developing these promising devices, there are still a number of unanswered questions – chief among them, how effectively they will compete against existing and upcoming next-generation durable stents, and how much of a price premium bioresorbable devices will be able to command.
Smith & Nephew’s recent purchases of two trauma businesses in Brazil and India (Pró Cirurgia Especializada and Adler Mediequip Pvt. Ltd.) reflect its broader strategy to find growth in emerging markets, an attempt to offset the losses and disappointing quarters the company is seeing in established markets like Europe.
