Johnson & Johnson Vision announced today that it received FDA approval for its Acuvue Theravision with Ketotifen. The eye health business arm of Johnson & Johnson (NYSE: JNJ) designed Acuvue Theravision with ketotifen (etafilcon A drug-eluting contact lens with ketotifen) to provide a new wearing experience for contact lens wearers who have allergic eye itch […]
Senseonics up on Q4 earnings beat, upcoming U.S. launch of Eversense E3
Senseonics (NYSE:SENS) shares are up today on Q4 earnings ahead of the consensus forecast, with the company planning to launch its next-gen, implantable, 6-month CGM in the U.S next month. The Germantown, Maryland-based company posted revenues of $4 million for the three months ended Dec. 31, 2021, representing sales growth of 2.6% from the same […]
Dexcom wins FDA breakthrough nod for use of its CGM in hospitals
Dexcom (NSDQ:DXCM) announced that it received FDA breakthrough device designation for the use of its CGM in a hospital setting. The FDA early in the COVID-19 pandemic issued temporary guidance allowing increased remote monitoring of hospital patients in order to limit contact with hospital staff. The guidance included continuous glucose monitors. “What started as a […]
Ascensia launches Senseonics’ remote monitoring app for Android devices in Europe
Ascensia Diabetes Care announced today that it launched Senseonics‘ (NYSE:SENS) Eversense NOW remote monitoring app for Androids in Europe. The launch makes remote monitoring capabilities available for all of Senseonics Eversense and Eversense XL continuous glucose monitoring (CGM) users on Android and iOS operating systems in the U.S. and Europe, respectively. Senseonics developed the Eversense […]
Pear Therapeutics advances in efforts to get CMS to cover prescription digital therapeutics
Pear Therapeutics (NSDQ:PEAR) announced that the Centers for Medicare & Medicaid Services (CMS) established new coding relevant to its prescription digital therapeutics (PDTs). CMS established a new Level II Healthcare Common Procedure Coding System (HCPCS) code to describe prescription digital behavioral therapy — FDA-cleared — per course of treatment, which extends to PDTs including Pear’s […]
ICU Medical beats The Street in Q4, posts full-year guidance
ICU Medical (NASDAQ:ICUI) shares rose today on fourth-quarter results that came in ahead of the consensus forecast. The San Clemente, California-based company posted profits of $19.9 million, or 91¢ per share, on sales of $340.5 million for the three months ended Dec. 31, 2021, for a 23.8% bottom-line slide on sales growth of 6.3%. Get the […]
Insulet posts Street-beating Q4 with Omnipod revenues up nearly 20% from 2020
Insulet (NSDQ:PODD) this evening reported fourth-quarter results that came in ahead of the Wall Street consensus forecast amid strong sales growth. The Acton, Massachusetts–based maker of Omnipod insulin delivery systems posted profits of $29.2 million, or 42¢ per share, on sales of $307.7 million for the three months ended Dec. 31, 2021, for a massive […]
Tandem Diabetes Care beats Street on Q4 sales, posts EPS miss
Tandem Diabetes Care (NASDAQ:TNDM) shares were slightly up on fourth-quarter results that beat the consensus revenue forecast. The San Diego-based company posted profits of $10.8 million, or 16¢ per share, on sales of $210 million for the three months ended Dec. 31, 2021, for a 36.4% bottom-line slide on sales growth of 24.9%. Tandem Diabetes […]
Medtronic’s diabetes business dips but CEO says growth will come
Medtronic (NYSE:MDT) announced growth in three out of four segments for the third quarter, with diabetes the only one to slide year-over-year. The Fridley, Minnesota-based medtech giant saw third-quarter revenue growth in its cardiovascular segment (3.4%), medical-surgical segment (1.2%) and neuroscience segment (0.8). However, the company’s diabetes business dipped 7.3% year-over-year in sales. In December 2021, […]
Baxter warns of alarm malfunction on some infusion pumps
Baxter (NYSE:BAX) announced today that it has issued an urgent safety communication regarding upstream occlusion alarms for certain infusion pumps. Deerfield, Illinois–based Baxter warned that incorrect administration set setup and/or the incomplete resolution of upstream occlusion alarms may result in reduced delivery or non-delivery of medication. The problem might occur without the users receiving alerts […]
