Better Therapeutics (Nasdaq:BTTX) announced today that it hit multiple key research milestones as it validates its digital therapeutics. San Francisco-based Better Therapeutics develops prescription digital therapeutics designed to deliver a novel form of cognitive-behavioral therapy for treating cardiometabolic diseases, potentially improving key measures related to type 2 diabetes, hypertension and more. Better Therapeutics’ platform aims […]
How Embecta is ‘uniquely positioned’ in diabetes space following spinoff from BD
Unlike most “new” companies, Embecta enters the playing field with nearly a century of history in diabetes. Nearly one year after BD (NYSE:BDX) announced its intent to spinoff its diabetes business, Embecta (Nasdaq:EMBC) now stands on its own. On April 1, the spinoff was made official, and Embecta became a standalone, publicly-traded company aiming to […]
GE Healthcare wins FDA premarket approval for software used in anesthesia delivery system
GE Healthcare (NYSE:GE) announced today that the FDA granted premarket approval for its End-tidal (Et) control software in anesthesia delivery. Approval covers the use of the Et control software for general anesthesia delivery on GE Healthcare’s Aisys CS2 anesthesia delivery system. The technology was released in Europe in 2010 and today can be used to […]
FDA approves IDE trial for Fractyl Health’s diabetes reversal tech in type 2 diabetes patients
Fractyl Health announced today that it received FDA approval for an investigational device exemption (IDE) trial of its diabetes reversal platform. Lexington, Massachusetts-based Fractyl Health will evaluate its Revita treatment in patients with type 2 diabetes whose disease is inadequately controlled despite treatment with at least two antidiabetic agents (ADAs) and who are not yet […]
Pear Therapeutics launches program to offer digital therapeutics through telehealth platforms
Pear Therapeutics (Nasdaq:PEAR) announced today that it launched a program to offer digital therapeutic users access to a telehealth provider. Boston-based Pear’s program offers patients seeking treatment for substance use disorder (SUD) or opioid use disorder (OUD) access to a telehealth provider through its “find a provider tool,” as well as in-person care options. According […]
Ascensia launches Senseonics’ next-gen 180-day Eversense E3 CGM in U.S.
Ascensia Diabetes Care announced today that it launched the Senseonics (NYSE:SENS) Eversense E3 system in the U.S. The next-generation Eversense E3 continuous glucose monitoring (CGM) system, developed by Germantown, Maryland-based Senseonics, received FDA approval in February for use lasting up to six months (180 days), making it the longest-lasting CGM sensor available in the U.S. Parsippany, […]
Dexcom launches Dexcom One CGM in the UK
Dexcom (NSDQ:DXCM) announced today that it launched the new Dexcom One continuous glucose monitoring (CGM) system in the United Kingdom. San Diego-based Dexcom designed the Dexcom One system as an easy-to-use, real-time CGM (rt-CGM) that it aims to make more affordable and accessible for people with diabetes in the UK. According to a news release, […]
BD completes spinoff of Embecta diabetes company
BD (NYSE:BDX) announced today that the planned spinoff of its diabetes business — named Embecta (Nasdaq:EMBC)— has been made official. Franklin Lakes, New Jersey-based BD announced its intention to spinoff the diabetes business in May 2021. Near the end of 2021, it unveiled the soon-to-be independent, publicly-traded company’s name as “Embecta,” with plans to complete the spinoff during […]
Medtronic issues voluntary recall for certain In.Pact drug-coated balloon catheters
Medtronic (NYSE:MDT) announced today that it voluntarily recalled a subset of its In.Pact Admiral and In.Pact AV balloon catheters. The company initiated the recent recall of the paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility. According to the company, approximately 6,000 In.Pact Admiral […]
Fresenius Kabi to acquire Ivenix and its smart infusion system for $240M upfront
Fresenius Kabi announced today that it will acquire Ivenix with plans to bring a comprehensive infusion product portfolio to the U.S. The acquisition, which has a purchase price of $240 million upfront, also includes potential milestone payments linked to achievements of commercial and operating targets. According to a news release, the companies expect the acquisition […]