St. Jude Medical expands its presence in the electrophysiology market after gaining European regulatory approval of FlexAbility, the company’s next-generation flexible ablation catheter, and expects to receive US FDA 510(k) clearance for the device by year-end.
After consulting with and receiving feedback from 22 outside physicians for nearly two years, the FlexAbility Ablation Catheter from St. Jude Medical Inc. is ready for its close-up. FDA 510(k) clearance is expected by year-end, preceded by CE mark this past July.
“The goal of FlexAbility was to bring the most advanced irrigated ablation solution to the electrophysiology market,” says Srijoy Mahapatra, MD, vice president of clinical, medical, and scientific affairs at...
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
Announced after three years of negotiation, the FTA eliminates tariffs on 99% of Indian product types, covering nearly all trade value, and reduces tariffs on 90% of UK products. Although not yet formally signed, the deal is being positioned by the Indian government as “transformative,” with an estimated economic impact of $6.4bn for the UK alone by 2040.
A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.
The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.
Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.
