FDA approved Johnson & Johnson's drug-eluting contact lens designed to treat allergic eye itch for contact lens wearers and reduces the need for eyedrops. Each Acuvue Theravision with Ketotifen lens contains 19 mcg of ketotifen – a well-established antihistamine.use a well-established antihistamine.
The wheels for using continuous glucose monitoring (CGM) systems in the hospital setting were put in motion early on during the pandemic, as FDA allowed both Dexcom and Abbott to supply CGM systems to hospitals. The devices allowed frontline healthcare workers in hospitals to remotely monitor patients' glucose levels while minimizing exposure to the virus and preserving use of personal protective equipment. Dexcom quickly saw the decision as an opportunity to possibly expand the use of the technology down the road to include hospital use beyond COVID-19. That road led to a recent breakthrough device designation to allow Dexcom to do just that.
In response to Pear Therapeutics' application, the Centers for Medicare & Medicaid Services (CMS) established a new code to describe prescription digital behavioral therapy, FDA cleared, per course of treatment. The code includes prescription digital therapeutics such as Pear's reSET, reSET-O, and Somryst, which are FDA authorized for the treatment of substance use disorder, opioid user disorder, and chronic insomnia, respectively. The code is scheduled to become effective on April 1.
And in case you missed our last Medtech in a Minute report...
Medtronic CEO Geoff Martha said the management team will be looking at the company's portfolio with a more critical eye, with a focus on growth, and creating shareholder value.
"I'd be surprised if there weren't changes over the coming fiscal year, but I don't know yet if they will be smaller or more significant," he said.
Based on industry trends and analyst comments, however, there's a good chance that we'll see changes on the larger side. It's also fair to keep in mind that, because of Medtronic's size and scope, even a smaller change could be viewed as a big change from an outsider's perspective.
Abbott won a new indication for the CardioMems Sensor to be implanted in NYHA Class II patients. The newly cleared FDA indication will allow it to reach an additional 1.2 million people living with heart failure. The device, which is about the size of a paper clip and placed in the pulmonary artery during a minimally invasive procedure, first won approval from FDA nearly eight years.
In a strong show of support for the company's iLet Bionic Pancreas, Beta Bionics has raised $57 million in a series C round. The funds will help commercialize the insulin dosing iLet Bionic Pancreas system. This adds to the series B and B-2 financings in 2018 and 2019 that raised about $126 million.