The US agency has published a list of more than 300 artificial intelligence/machine learning devices it has allowed on the market, highlighting the work it has done to review these new and complicated products.

Vasum Peiris, an MD and the US agency’s chief medical officer for pediatrics and special populations, is worried about the lack of innovative devices for young people. But he’s hopeful that real-world evidence could turn that around.

On this week’s podcast: One of the more interesting and important trends in medtech in recent years is the emergence of robotic assisted surgery. But as RAS procedures increase, so do the chances of something going wrong. And when it does, who’s to blame? The robot or the surgeon?

The Washington Legal Foundation says California’s appeals court should see Ethicon’s statements about pelvic mesh as protected scientific speech.

The regulation of medicines and medical devices have long worked along parallel, but very different, lines. Now there is increasing pressure for them to also be jointly improved to support innovation.

The Paige Prostate is a first-of-its-kind digital prostate imaging analysis software that can act as an extra pair of eyes to help pathologists spot cancer cells.

A May recall of 25,000 Super Torque MB Angiographic Catheters with Radiopaque Marker Bands was given the high-risk classification by the US agency on 22 September.

The medtech giant yanked from shelves in July its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology. The recall was labeled high-risk class I by the US FDA on 20 September. It’s the company’s ninth class I this year.

The US agency has warned health care providers that certain devices used to warm fluids for bodily circulation could leach dangerous levels of aluminum.

The US agency has published a list of more than 300 artificial intelligence/machine learning devices it has allowed on the market, highlighting the work it has done to review these new and complicated products.

The Paige Prostate is a first-of-its-kind digital prostate imaging analysis software that can act as an extra pair of eyes to help pathologists spot cancer cells.

Boston Scientific will pay $269m for the 84% of Devoro that it does not already own and up to $67m upon achievement of certain clinical and regulatory milestones.

Results showed that patients were less likely to exhibit disease progression, or die, following treatment with beta-emitted microspheres.

Caresyntax raised $130m in total funding to expand commercialization of its software that seeks to reduce variability and improve outcomes in the operating room.

The mixture in some faulty Abbott PCR tests could cause COVID-19 positive samples to flow into neighboring negative samples, resulting in false-positive results.

Vasum Peiris, an MD and the US agency’s chief medical officer for pediatrics and special populations, is worried about the lack of innovative devices for young people. But he’s hopeful that real-world evidence could turn that around.

A pilot study of the augmented reality system suggests it improves the precision of knee arthroplasty surgery.

Portico with the FlexNav delivery system earned FDA approval for people with symptomatic, severe aortic stenosis who would be at high or extreme risk in open-heart surgery.

Caresyntax raised $130m in total funding to expand commercialization of its software that seeks to reduce variability and improve outcomes in the operating room.

Illumina selected seven start-ups to join the third funding cycle of its Accelerator in the US and UK.

In an interview with Medtech Insight, Stereotaxis CEO David Fischel explained how the company intends to continue its recovery after a troubled near decade of decline.