LDT Oversight Gets Long-Awaited FDA Final Rule
The final rule is sure to shake up the diagnostic industry, for better or worse, depending on who you talk to.
The final rule is sure to shake up the diagnostic industry, for better or worse, depending on who you talk to.
The deal comes during a time when M&A is becoming more prevalent in the medtech industry.
In part 1 of MD+DI’s interview with Jim O’Connell, he highlights the integration process of Hillrom into Baxter as the acquisition marks two years.
First-of-its-kind, Esprit BTK Everolimus Eluting Resorbable Scaffold System is designed to keep treat chronic limb-threatening ischemia below the knee and deliver Everolimus to support vessel healing through a stent that dissolves over time.
The company said it would pay $1.1 billion to settle claims over its recalled Respironics devices.
The Burlington, NC-based company has been selected as the winning bidder to acquire Invitae’s assets for $239 million.
Upgrades to a recently acquired moldmaking shop in Denmark include 5-axis laser texturing and high-speed milling as well as automated handling systems.
The company is recalling the needles from one batch as it may contain microscopic stainless-steel debris on the inside of the needle.
Bethany Corbin details the importance of understanding these issues, citing femtech examples like reproductive health privacy post-Dobbs v. Jackson Women’s Health Organization and potential alienation of intended users.
The company addressed results from a clinical trial that pitted Medtronic’s Evolut platform against the Sapien valve.