Companies

Small sterilizers told Medtech Insight that they were ready for the EPA’s controversial EtO emissions rule, while community advocates expressed concerns.

Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.

The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.

A study of diabetes rates across the US over four years reveals significant increases in the disease in many states. Tobias Oerum, diabetes advocate and cofounder of the company that conducted the study, discussed the data and some of the factors contributing to this troubling trend with Medtech Insight.

The US FDA has cleared a novel software application to enhance the analysis of bone marrow smears. Using the AI-powered tool, hematopathologists may be able to better diagnose various blood and marrow diseases.

Theradaptive, which makes a device-biologic combination product to help speed bone healing, recently got authorization to start human trials from the US FDA. Medtech Insight spoke to CEO Luis Alvarez about the company’s past, present and future.

A consent decree agreed to in January between Royal Philips and the US government is now official. The decree stems from a recall in 2021 of millions of the company’s sleep therapy and breathing devices due to risks posed by the sound abatement foam inside the machines.

Abbott’s trial win for patent infringement by DexCom’s CGM systems still doesn’t have information on damages awarded due a hung jury.

J&J’s acquisition of IVL device maker Shockwave Medical for $13.1bn sets J&J’s medtech arm solidly in a leadership position in multiple cardiovascular markets.

The US FDA has cleared an AI tool from Eko Health that could help doctors detect heart failure during routine physical exams. Developed with the Mayo Clinic, the tool can pick up a key early indicator for heart failure, which can often go undiagnosed.

The US FDA has cleared the NeuroStar transcranial magnetic stimulation system to treat depression in adolescents 15 through 21, making it the first and only such treatment the agency has cleared for this age group.

The US FDA has approved Roche’s cobas Malaria test, which screens blood donors in the US for malaria. The cobas is the first such diagnostic to win agency approval.

Regulatory reliance was the theme on Day one of the 25^th Management Committee of the International Medical Device Regulators Forum in DC, with regulators from across the globe touching on the need for clarity, consistency, and trust among the world’s various regulatory bodies. The attendance for this year’s meeting was largest in the history, with some 1,200 guests representing more than 60 countries and 550 public and private sector organizations.

Medtech Insight's News We're Watching covers medtech industry and research news you may have missed. This week, the Advanced Technologies and Treatments for Diabetes (ATTD) conference in Florence, Italy, included new results from studies of Roche's continuous glucose monitor and Medtronic's 780G insulin pump, Medtronic moved closer to earning FDA approval for its Affera ablation mapping and ablation system, and Linus Health expanded its technology for finding signs of cognitive problems in speech data.

Abbott’s weaker rapid diagnostic sales see the erstwhile industry leader slip down the global 2023 medtech rankings, while Johnson & Johnson passes it on the way up on the back of strong external and internal growth.

Medtech Insight caught up with Sean Salmon, the president of Medtronic's cardiovascular business, to talk about the long-awaited FDA approval of the Symplicity Spyral renal denervation system, recent approvals of the PulseSelect pulsed field ablation system and extravascular ICD, and the company's plans for transcatheter aortic valve replacement.