CMS proposes new pathway for reimbursing breakthrough devices
A long-awaited CMS effort could make the path to reimbursement easier for medical device makers, Lizzy writes. A new proposal outlines the Transitional Coverage for Emerging Technologies program, which would apply to FDA-designated "breakthrough devices." The goal is to streamline the process for securing Medicare coverage, potentially overcoming the "valley of death" device makers face between scoring approval and actually getting covered.
Under the voluntary pathway, device makers could access CMS officials before FDA market authorization. Officials would review early evidence, help manufacturers design studies and guide them on existing coverage areas. The goal is to finalize coverage within six months of FDA clearance, according to CMS. Read more from Lizzy, and to keep up on the space, check out our Breakthrough Device Tracker.
Muscle sensor company sees early promise in a pig
Phantom Neuro, a small startup working on a muscle sensor to allow better control of prosthetic limbs, has tested its device on a pig and found that could decode the pig's movements in real time, Lizzy tells us.
Lizzy spoke with founder Connor Glass about the company's proof of concept in the pig (also named Lizzy!), and his eventual goal of implanting the device under the skin at the site where a patient's body connected to the robotic prosthetic. The device would communicate the amputated limb's movements to the person's phone, and after that, to the prosthetic.
"We put it on top of the muscle in the shoulder of this pig, and in real-time recorded the muscle activity from the pig as it walked on a treadmill," Glass said. "Then we used that to drive control of a virtual robot pig leg." The company team will continue working on making the sensor communication more seamless, and eventually testing it on sophisticated robotic limbs. In the meantime, Phantom Neuro has built out its board with Thomas Oxley, CEO of brain-computer interface company Synchron, and Joshua Duyan, former Chief Strategy Officer of CTRL labs. The company has raised around $9 million, according to AlphaSense.
Babyscripts expands maternal health tech in South
A few months ago I wrote about the potential for maternal health tech — digital scales, connected blood pressure cuffs, and remote monitoring apps — to meaningfully address major health inequities across marginalized, medically underserved populations. But the technology's not always within reach for the cash-strapped health systems that want to help.
Babyscripts, a maternal health tech company with an app that health systems can customize for their patients, recently announced a partnership with Memorial Hermann in Southeast Texas. Memorial Hermann patients using the app will get educational content, appointment reminders, and suggestions for behavioral changes.
The health system wouldn't share how much the technology cost, nor how many patients it aims to sign up. But Victoria Regan, VP of women's and children's services at the health system, said its goals were to improve in-network utilization and patient experience scores.
Providers already like that they're able to customize the educational content for individual patients — including maps and lists of pediatricians — and also prepare them for appointments, she said.