BioSig Technologies (Nasdaq:BSGM) announced today that it terminated “a significant number of its employees.” Shares of BSGM were up 3.1% to 64¢ apiece in mid-morning trading today following the announcement. With this latest workforce reduction, the company says it expects to “substantially reduce business operations.” Today’s announcement marks the company’s second significant headcount cut in […]
Patient Monitoring
FDA clears first over-the-counter fingertip pulse oximeter from Masimo
Masimo announced today that it received FDA clearance for its MightySat Medical over-the-counter fingertip pulse oximeter. The company says that the regulatory nod makes MightySat Medical the first and only FDA-cleared medical fingertip pulse oximeter available over the counter (OTC), direct to consumers without a prescription. Irvine, California-based Masimo powers its OTC pulse oximeter with […]
Tandem Diabetes Care launches Mobi mini automated insulin patch pump
Tandem Diabetes Care (Nasdaq:TNDM) announced today that it kicked off the U.S. commercial launch of its Mobi insulin patch pump. The San Diego–based company says Mobi, which is fully controllable from a mobile app, is the world’s smallest durable automated insulin delivery (AID) system. It received FDA clearance for people with diabetes ages six and […]
Canary Medical has first-in-human implant of heart sound monitor
Canary Medical announced today that it completed the first-in-human limited feasibility trial of its cardiac auscultation monitoring device. Vancouver, British Columbia–based Canary is developing the device as a first-in-class implantable sensor. It provides daily adjunctive objective cardiac parameter measurements. The company believes it could enable patients and clinicians to better manage congestive heart failure symptoms. […]
Senseonics earns expanded Medicare coverage for long-term implantable CGM
Senseonics (NYSE:SENS) and Ascensia Diabetes Care today announced expanded Medicare coverage for the Eversense E3 CGM system. Medicare implemented Local Coverage Determinations (LCDs) providing access to implantable CGM for basal-only patients. It significantly expands access to Senseonics’ long-term (six months) implantable glucose monitor. The expansion for implantable CGMs includes all people with diabetes using insulin. […]
Study says Masimo pulse oximetry is accurate for different skin colors
Masimo today announced findings from a study evaluating its pulse oximetry technology across a variety of skin pigmentations. Dr. Vikrant Sharma, Dr. Steven Barker, Dr. William C. Wilson and colleagues at Masimo performed a focused analysis of previously published data evaluating the impact of low perfusion on the performance of Masimo SET pulse oximetry across […]
Dexcom says revenues could grow 20% in 2024
Dexcom shares dipped after hours on fourth-quarter results that came in ahead of the consensus forecast. Shares of DXCM fell 1.6% at $125 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day up 0.2%. The San Diego-based continuous glucose […]
Insulet integrates Abbott FreeStyle Libre 2 Plus, Omnipod 5 in Europe
Insulet announced today that it received CE mark approval for the integration of the Abbott FreeStyle Libre 2 Plus with Omnipod 5. European approval covers the compatibility of Abbott’s glucose sensor with the Insulet automated insulin delivery system for individuals aged two years and older with type 1 diabetes. Currently, Omnipod 5 works with Dexcom […]
Former Tandem CCO joins Ascensia as president of CGM
Ascensia Diabetes Care parent company PHC Holdings and Senseonics announced today that Ascensia named Brian Hansen its president of CGM. Hansen’s appointment to the newly created role at the global distributor of Senseonics’ Eversense CGM went into effect today, Feb. 6. Responsibilities for Hansen include the global commercialization and growth of the Eversense system. The fully […]
Philips wins FDA nod for latest IntelliVue patient monitor software including Sounds alarm package
Philips announced today that it received FDA 510(k) clearance for its latest IntelliVue patient monitor software. The latest IntelliVue technology includes several new solutions, including the Philips Sounds alarm package. This clearance means the alarm package now has availability in the U.S. and more than 200 countries worldwide. Philips worked with clinicians and sound experts […]
Dexcom launches new ONE+ CGM system in Europe
Dexcom announced today that it launched its latest continuous glucose monitor (CGM) system, the Dexcom ONE+. The San Diego-based company began rolling out the system in Spain, Belgium and Poland. It plans for a launch next week in the Netherlands, too. In some countries, the system replaces the previous-generation Dexcom One sensor. ONE+ uses Dexcom’s […]