Michael Barbella, Managing Editor10.28.23
Product approvals and personnel news were the dominant favorites this past week on the MPO website.
Taking the top spot was the resignation of Ashley McEvoy, executive vice president and worldwide chairman of Johnson & Johnson MedTech, who joined the company 27 years ago in the Consumer Products Group. She is stepping down from her position to pursue other opportunities but will remain with the company into Q1 2024 to support her successor's transition. Tim Schmid has subsequently been appointed to her position.
Insulet, Sequel, and Medtronic, meanwhile, drove traffic with word of their respective product approvals/clearances. The FDA's clearance of Insulet's Omnipod 5 App for iPhone gives it the distinction of being the first and only company with a tubeless, automated insulin delivery (AID) system with full control from a compatible Android and iOS smartphone. The Omnipod 5 App for iPhone offers the same functionality as the app for Android—plus additional capabilities, Insulet said. Users will have access to a new custom foods feature to save carbohydrate data for favorite foods, snacks, or meals that are consumed frequently.
Sequel also achieved a first, receiving FDA approval as a medical device for its spiral tampon, which is designed to be more comfortable and less prone to leakage. The startup firm's first novel product, the Sequel Spiral Tampon, features a proprietary spiral design that is engineered to be more fluid mechanically efficient, meaning it is designed to absorb more evenly and not leak before it’s full.
Medtronic also scored a "first" with the FDA approval of its Aurora EV-ICD MRI SureScan (extravascular implantable cardioverter-defibrillator) and Epsila EV MRI SureScan defibrillation lead to treat dangerously fast heart rhythms that can cause sudden cardiac arrest. According to Medtronic, Aurora is the first of its kind to have the same benefits as traditional, transvenous ICDs with a lead placed under the breastbone, outside of the heart and veins.
Taking the top spot was the resignation of Ashley McEvoy, executive vice president and worldwide chairman of Johnson & Johnson MedTech, who joined the company 27 years ago in the Consumer Products Group. She is stepping down from her position to pursue other opportunities but will remain with the company into Q1 2024 to support her successor's transition. Tim Schmid has subsequently been appointed to her position.
Insulet, Sequel, and Medtronic, meanwhile, drove traffic with word of their respective product approvals/clearances. The FDA's clearance of Insulet's Omnipod 5 App for iPhone gives it the distinction of being the first and only company with a tubeless, automated insulin delivery (AID) system with full control from a compatible Android and iOS smartphone. The Omnipod 5 App for iPhone offers the same functionality as the app for Android—plus additional capabilities, Insulet said. Users will have access to a new custom foods feature to save carbohydrate data for favorite foods, snacks, or meals that are consumed frequently.
Sequel also achieved a first, receiving FDA approval as a medical device for its spiral tampon, which is designed to be more comfortable and less prone to leakage. The startup firm's first novel product, the Sequel Spiral Tampon, features a proprietary spiral design that is engineered to be more fluid mechanically efficient, meaning it is designed to absorb more evenly and not leak before it’s full.
Medtronic also scored a "first" with the FDA approval of its Aurora EV-ICD MRI SureScan (extravascular implantable cardioverter-defibrillator) and Epsila EV MRI SureScan defibrillation lead to treat dangerously fast heart rhythms that can cause sudden cardiac arrest. According to Medtronic, Aurora is the first of its kind to have the same benefits as traditional, transvenous ICDs with a lead placed under the breastbone, outside of the heart and veins.