Spotlight On... Materialise CEO calls for industry standards for 3-D printed medical devices; Akili starts pivotal trial for ADHD video game; FDA clears updated a-fib device Lariat XT;

Major medical device makers--and hospitals themselves--are busily rolling out 3-D printed medical devices and products. But now a major player in the effort has called for a bit of a timeout to agree on a common standard for the clinical, economical and patient outcomes of medical 3-D printing. The CEO of Materialise ($MTLS), Fried Vancraen, which sells 3-D printing software and printing solutions to hospitals, is calling for "a set of globally accepted guidelines adopted by the major medical 3D printing industry players." He argues this is necessary to facilitate the next leg of adoption by physicians and hospitals--as well as to encourage regulators and payers to add 3-D printed medical devices and products to their approved lists. "There have been several initiatives aimed at properly measuring and validating the clinical benefits of medical 3-D printing, but all have suffered from a lack of coordination and agreed-upon research methodologies," Vancraen said in a statement. "With the proper scientific rigor, our ambition of gaining widespread acceptance of medical 3-D printing will be realized more swiftly, and the patients whom we aim to serve will benefit the most." More

> PureTech Health ($PRTC) company Akili Interactive is starting enrollment in a pivotal trial of a treatment for attention deficit hyperactivity disorder (ADHD). Dubbed a "digital medicine," the technology is delivered via an action video game interface. It aims to improve problem-solving, memory and self-regulation. More

> The FDA has cleared Lariat XT, a soft tissue closure device from SentreHeart. This is an improvement on an atrial fibrillation device. More

> St. Jude Medical ($STJ) has presented positive pivotal trial data at the Heart Rhythm Society conference in San Francisco, CA, for its MultiPoint Pacing tech in its recently CRT-D and CRT-P devices. More