AdvaMed CEO Scott Whitaker shared a letter he sent to member companies voicing support for the ongoing protests around the US against police brutality that were sparked after the killing of George Floyd. “While we continue our single-minded pursuit of medical breakthroughs to treat and cure disease, we must also have a single-minded focus on eradicating the disease of racism in this country and around the world,” Whitaker wrote.
For an organization that tends to stay out of the political fray, the medtech lobby group AdvaMed took the unusual step of voicing support for protesters who’ve been carrying out nationwide demonstrations calling for law enforcement reforms after a black man was killed by a police officer in Minneapolis, MN.
AdvaMed CEO Scott Whitaker on 3 June published a letter on LinkedIn that was sent to all the group’s...
Volta Medical received a labeling expansion for its AF-Xplorer mapping software to treat A-fib, which provides the clinical evidence needed to broaden US access. The company hopes for FDA clearance for its improved second-gen AF-Xplorer II software.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
In this in-depth interview with Medtech Insight, Pavan Choudary unpacks the implications of recent free trade agreements (FTAs) such as India’s with the UK, the potential fallout from new US tariffs on Indian device exports, and the pressing need for regulatory harmonization.
SS Innovations reported its first SSi Mantra 3 robotic cardiac surgery in South America as it prepares to file for US FDA de novo clearance and a CE mark. The firm aims to challenge Intuitive Surgical with a lower-cost, flexible system targeting US and European markets.
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Ahead of the ADA conference, Abbott announced Tandem as the fourth partner to integrate Abbott’s dual glucose-ketone sensor with automated insulin delivery. Expanded Medicare CGM coverage, FDA label expansions and new ADA guidelines position Abbott to grow its CGM footprint in a competitive market.
"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.
