Waveguide Corp., of Cambridge, Mass., has launched the first portable, battery-powered nuclear magnetic resonance (NMR) device, Waveguide Formμla, offering rapid, on-site screening and diagnostics at an affordable price. The company maintains its new micro NMR performs as well or better than larger, benchtop NMRs and requires minimal training to operate.

Nevro shines following quarterly results, positive news on NSRBP study

Nevro Corp.’s stock was up following encouraging results detailed during its fourth-quarter earnings call. Management predicted a positive 2020, highlighting the potential of the U.S. spinal cord stimulation market. William Blair's Margaret Kaczor noted that one aspect of the call that surprised her was the commentary related to the company's nonsurgical refractory back pain (NSRBP) randomized controlled trial. “A third-party statistician determined that following an interim look the trial is already adequately powered,” she wrote. “The update potentially accelerates a path to improving reimbursement coverage for the 300,000 NSRBP patients domestically and adds another meaningful catalyst to 2021.”

Judge orders HHS to fill 10-year data gap on Clinicaltrials.gov

While the staff at the U.S. Department of Health and Human Services (HHS) is currently all hands-on-deck in responding to the COVID-19 outbreak, some of the agencies in the department may have to divert resources to get sponsors of drug and device clinical trials to fill in nearly a decade-long data gap on Clinicaltrials.gov. That’s if a judge’s decision handed down this week stands. The gap stems from HHS’ long delay in issuing a final rule to implement a provision in the 2007 FDA Amendments Act requiring basic data to be submitted to Clinicaltrials.gov for applicable clinical trials of drugs and devices, regardless of whether they were approved, licensed or cleared.

Speakers make case for home-use ultrasound with help of AI

The second day of the FDA workshop on artificial intelligence (AI)  in health care featured several interesting proposals, including the argument that AI will at some point be used in health care without the aid of a health care professional. John Martin, the chief medical officer at Butterfly Network Inc., of Guildford, Conn., said the time is ripe for AI-assisted ultrasound in the home, which he claimed could reduce rehospitalizations in heart failure, one of the holy grails in U.S. government efforts to restrain health care spending growth.

Vygon acquires APD, specialists in innovative monitoring systems for critical care

PARIS – Vygon SA, of Ecouen, France, has acquired Advanced Perfusion Diagnostics SA (APD), a startup company based in Lyon, France. APD is the develop of Ikorus, a device that detects changes in visceral microvascular blood flow in the most critically ill hospital patients.

Also in the news

Aidoc, Cardiac Dimensions, Concord Technologies, Allosure, Cryoport, Dana-Farber Cancer Institute, Fluidigm, Fresenius Medical Care North America, Inception Fertility, Iqvia, Instrunor, Iradimed, Jvion, Livanova, Lucidhealth, Neosync, Nuvasive, Rti Surgical, Sophia Genetics, Senseonics, Stryker, Swittons, Twist Bioscience, Veeva, Wave Neuroscience, Wright Medical