In another boost to its diabetes portfolio, Medtronic plc was granted CE mark approval for its Simplera continuous glucose monitor (CGM) sensor. The EU greenlight for Simplera follows the U.S. FDA approval for Medronic’s Minimed 780G insulin pump system earlier in the year. Simplera is an all-in-one disposable CGM sensor which features a two-step insertion process and will help patients who must have multiple daily injections (MDI) manage their diabetes. Read More
At its Investor Day on September 20, Boston Scientific Corp. unveiled an ambitious long-range plan to become “the highest performing med-tech large-cap company” in terms of financial performance, sales growth, EPS, execution and talent retention.” That’s a notable step up from its 2021 goal of being just one of the top performers. Read More
The U.S. Supreme Court has heard two cases this year regarding the False Claims Act (FCA), including the Shutte v. Supervalu case, which the court has remanded to the Court of Appeals for the Seventh Circuit. However, even though the case has not come to a close, Jay Stephens of Kirkland & Ellis LLP, believes that the Supreme Court’s handling of Supervalu creates an environment in which the process of discovery will become much more burdensome for all involved. Read More
Medtech Europe has on several occasions given voice to concerns about the drawn-out overhaul of the European Union’s medical device regulation but has come up with a new set of recommendations to break the regulatory logjam. Read More
The co-founders of Zero Candida Ltd. described, in the company’s first PCT filing, their development of a drug-free solution for treating vaginal fungal infections using an intravaginal light-based treatment device (ILTD) that projects light at predefined intervals and intensities to treat infection. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Enovis, Limacorporate, Orion Health, Pieces Technologies, Veradigm, Vicarious Surgical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Honeynaps. Read More
