PHILADELPHIA – Questions about running clinical trials in U.K. and Horizon 2020 took center stage at the MedTech Conference Tuesday, with one audience member expressing doubt that a no-deal Brexit is unlikely. "It isn't nothing, but equally it's not everything," said Lord James Richard O'Shaughnessy, Parliamentary Under Secretary of State at the Department of Health, in a session that sought to emphasize that the U.K. will remain open for business, irrespective of Brexit. He attempted to explain what to expect ahead of the March 29, 2019, Brexit date.
PHILADELPHIA – What is one of the biggest risks to the med-tech industry's growth? According to Pulse of the industry, the 2018 EY medical technology industry report, it is ignoring R&D spend and underinvestment in digital capabilities. Instead, med-tech companies remain focused on near-term growth, ignoring what can boost them in the longer run. Additional findings were presented during the MedTech Conference 2018.
After remaining relatively quiet on the M&A front, Dublin-based Medtronic plc reported late Thursday that it had entered a deal to buy Mazor Robotics Ltd., of Caesarea, Israel, for about $1.64 billion in cash, with an eye toward enhancing its technologies for spine surgery. The transaction builds on a relationship initiated in May 2016 under a strategic and equity investment agreement between the two companies.
A new incubator cofounded by an executive from Edwards Lifesciences Corp. is looking to develop technologies for unmet needs. Deerfield Management reported this week that it had teamed up with Stan Rowe, who was chief scientific officer at Edwards Lifesciences Inc., to create Nxt Biomedical. The incubator is expected to invest up to $25 million, with Deerfield handing over an additional $250 million for the formation and development of five to eight startup companies that emerge from the incubator.
Ahead of the Transcatheter Cardiovascular Therapeutics (TCT) 2018 conference, Kirkland, Wash.-based Cardiac Dimensions Inc. reported the randomization of the first patient in the CARILLON pivotal trial for the treatment of functional mitral valve regurgitation (FMR) associated with heart failure. The multicenter, double-blinded, randomized controlled trial is expected to randomize 450 patients at up to 75 centers in North America and Europe.
Broncus Medical Inc., of San Jose, Calif., is highlighting data that it says shows that the Archimedes virtual bronchoscopy navigation system significantly improves access to solitary pulmonary nodules (SPN). The company noted that the system helps increase the diagnostic yield for nodules without a bronchus sign or an airway leading to the nodule. The data were unveiled at the European Respiratory Society (ERS) International Congress being held in Paris this week.
For the first time in nearly two decades, the FDA has approved a device intended to treat acute coronary artery perforations. The PK Papyrus covered coronary stent system, from Biotronik Inc., of Lake Oswego, Ore., won approval under a humanitarian device exemption for use in the emergency treatment of tears in the blood vessels of the heart.
The FDA emphasized the power of digital health and how it empowers consumers this week in the wake of a major unveiling by Apple Inc., namely, a feature that will allow the user to take an electrocardiogram (ECG) via Apple Watch. FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren emphasized that the agency is looking to move these products forward and noted its work with Cupertino, Calif.-based Apple.
