Years after a setback to its clinical program, Medtronic plc‘s Symplicity brand renal denervation (RDN) system appears to be firing on all pistons. The Dublin-based company said this week that it will begin enrolling patients in a pilot study to assess the safety and efficacy of its newer-generation Symplicity Spyral using a targeted procedural approach with fewer radiofrequency (RF) ablations. Read More
With an eye toward expanding the reach of its Febridx rapid point-of-care (POC) test, Lumos Diagnostics Holdings Pty. Ltd. has seen the closing of a $15 million series A round from Australia’s Planet Innovation. The funds will back a U.S. FDA pivotal clinical trial, as well as additional development and manufacturing resources for the company’s expanding full-service POC business. Read More
Medicare coverage of ventricular assist devices assumes the patient is either in end-stage heart failure or could become a candidate for transplant, but that approach may soon change. Abbott Laboratories, of Abbott Park, Ill., has asked that Medicare coverage assume the patient can recover myocardial function, a paradigm shift that is backed by clinical evidence. Read More
The drug screens prompted by the SARS and MERS outbreaks have been useful for quickly identifying drug candidates. But in terms of their epidemiology, “SARS and MERS were different from this coronavirus,” Allison McGeer explained at a Feb. 3 webinar by Evercore ISI. Read More
Touting the efforts his administration already has taken to lower U.S. prescription drug prices through increased competition, President Donald Trump placed the burden for further action squarely on Congress during his State of the Union address Tuesday, Feb. 4. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Accuray, Cytosorbents, Htg Molecular Diagnostics, Tela Bio. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CHF Solutions, Eyeyon Medical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advantage Choice Care, Cardinal Health, Ethicon, Tele Medcare. Read More
Keeping you up to date on recent developments in orthopedics, including: After a bone injury, shape-shifting cells rush to the rescue; Machine-learning tool identified predictive factors associated with worse patient outcomes after arthroscopic hip surgery; New injection technique may boost spinal cord injury repair efforts; Does tramadol increase hip fracture risk? Read More
