Here are some of the top stories at MedCity News this week:
— A mention this week by talk show host Rush Limbaugh of Envoy Medical Corp.’s implantable device for hearing loss helped resurrect this story from our archives: It took nearly 15 years, $105 million, a name change and countless technical hiccups for Envoy Medical investors to finally see an endgame. More accurately, they can hear an endgame. In December, a scientific panel advising the Food and Drug Administration unanimously recommended the agency approve the company’s Esteem technology, an implantable device designed to help patients with moderate to severe hearing loss. The decision paved the way for the FDA to formally approve Esteem in February, allowing Envoy to start selling the $30,000 system in March. Check out the patient testimonies at the bottom of the story. Maybe Limbaugh is the only one who can afford the device.
— David Anderson says the road to developing an artificial spinal disc nucleus is littered with “spectacular failures.” But that doesn’t deter Anderson or his company, Philadelphia-based Gentis, from trying to be the first to get a disc nucleus replacement device for the lower spine on the U.S. market. Earlier this year, Disc Dynamics became one of those spectacular flameouts that Anderson mentioned. Gentis hasn’t made it as far as Disc Dynamics did, but Anderson hopes to file early next year for European approval to begin selling its device, the DiscCell. The device has been implanted in fewer than 10 patients in an ongoing clinical trial in Europe.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
— Explorys Inc., the Cleveland, Ohio, startup that is putting healthcare data management, analytics and outcomes measurement on the Internet, has raised $2.55 million in Series B funding from Sante Ventures and Cleveland Clinic Innovations. Founded last year by data management veterans Stephen McHale and Charlie Lougheed in collaboration with the Cleveland Clinic, Explorys provides specialized data services and applications that empower healthcare providers to improve treatment, and biotech and pharmaceutical companies to accelerate research and product development at the same time as measuring performance and drug safety. Explorys will use its latest fundraise to continue developing platform technologies, such as drug-safety detection and third-party software development interfaces.
— What makes a good doctor in the United States? Certainly one that graduates from a prestigious American medical school. And one that’s also pretty good at the sciences, like physics and chemistry. But two recent studies suggest we should think more broadly — both figuratively and literally. A study published last week in Academic Medicine, the journal of the Association of American Medical Colleges, says students who majored in humanities and social sciences performed just as well in medical school as students who took traditional hard science classes. Another study published Tuesday in the journal Health Affairs says foreign-born doctors trained overseas actually achieved lower patient death rates than American-born, American medical school graduates.
— Thermedx LLC has received Food and Drug Administration market clearance for its surgical fluid management system. It’s the first market clearance for the Solon, Ohio, company since it started in 2007. Its 37-5 Fluid Management System enables users to manage and/or warm up to five fluids used to irrigate surgical sites during urologic, gynecologic, orthopedic and general surgeries, according to a Thermedx release. Millions of Americans suffer hypothermia during surgery each year, the company said.
