4+ day, 16+ hour ago   (1103+ words) The medtech industry is awaiting FDA guidance on generative AI. The agency has sought feedback in advisory meetings and a discussion paper as the technology becomes more prevalent. The Food and Drug Administration is working on guidance for use of…...

1+ week, 3+ day ago   (336+ words) A problem with the leads could cause inadequate stimulation, Boston Scientific said. In the worst case, leads may need to be removed or replaced. The lead is a component in spinal cord stimulation systems used to manage chronic pain. Leads…...

1+ week, 4+ day ago   (374+ words) The orthopedics specialist aims to launch a knee robot in late 2028, followed by a shoulder robot in 2029. Buying eCential will position Enovis to add robotics capabilities to its Astra enabling technology system, which currently includes an augmented reality headset and…...

1+ week, 5+ day ago   (449+ words) The diabetes tech firm is preparing for the launch of new devices, including a tubeless insulin pump and a fully closed loop automated insulin delivery system. Following the debut of its smallest insulin pump, diabetes tech firm MiniMed is planning…...

2+ week, 2+ day ago   (466+ words) The attack has affected the company’s ability to manufacture products and to process and ship customers’ orders, and there is still no timeline for restoration. Boston Scientific remains in a network outage, and operations like manufacturing and shipping products are…...

2+ week, 4+ day ago   (483+ words) The attack affected global operations, and its full scope is still being determined, the medical device maker said in a securities filing. Boston Scientific on Wednesday disclosed a cyberattack that has affected the company’s ability to process and ship customers…...

2+ week, 5+ day ago   (400+ words) Jonathan Pratt will take over the role on Sept. 1. The announcement ends Qiagen’s nearly 10-month search for a new chief executive. New title: CEO, Qiagen Previous title: CEO, Filtration Group Qiagen said Monday it has appointed Jonathan Pratt as CEO,…...

2+ week, 6+ day ago   (252+ words) Sondermind and Limbic are evaluating digital health devices intended to help with anxiety and depression. London-based Limbic will offer an AI mental health service called Unpacked as part of the program. The service provides cognitive behavioral therapy for people with…...

2+ week, 6+ day ago   (208+ words) The company has begun a major marketing campaign to support the launch of its MiniMed Flex insulin pump. The company received Food and Drug Administration clearance for MiniMed Flex in March and made the product available in the U.S. with the…...

3+ week, 2+ day ago   (697+ words) Stryker, Medtronic and Abbott are among the collection of medical device firms that have disclosed cyberattacks this year. Check out MedTech Dive’s roundup of coverage. The healthcare system has long been the target of cyberattacks — in recent years, hospitals and…...