Health care industry groups expressed support after the high court found that Texas and 17 other Republican-led states lacked standing to file suit because they hadn’t shown the act had directly harmed them.

Jeff Shuren, director of the US FDA’s device center, promised in a podcast interview with AdvaMed that the agency’s backlog of in vitro diagnostic submissions not related to COVID-19 will begin abating “in the next few weeks.”

With the UK on the cusp of a public consultation on the UKCA marking, directors at the ABHI stress the vital need for the MHRA to review all options in setting the right medtech regulatory framework.

The US agency is asking medtech companies to fund a program that would bring together external experts to advise on their products early on, but industry is skeptical about the program’s ability.

US President Joe Biden’s proposed budget for fiscal 2022 allocates $133.7bn for HHS, a 23% increase for the department from fiscal 2021; the administration is also asking for $6.5bn for the FDA, an 8% increase from the agency’s current budget.

With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.

With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.

Medtech quality expert Rob Becker says the COVID-19 pandemic has likely changed the structure of audits and inspections forever, possibly ending the use of on-site “front rooms” where inspectors would work and “back rooms” where company employees would fulfill requests for documents and other items.

Sound abatement foam used in particular bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices made by Royal Philips could degrade, posing a risk to patients.

The series F financing will allow the company to expand clinical research supporting its unique duodenal mucosal resurfacing approach to treating metabolic disease at its source.

Becton Dickinson claims Beckman Coulter has been knowingly violating several patents since at least 2015.

MedTech Innovator has announced the 50 companies competing in its annual Showcase and Accelerator program, which will culminate at The Medtech Conference in September, where the winners will be awarded a $350,000 prize.

To bolster its life sciences and diagnostics portfolios, Novo Holdings has made another major investment to acquire BBI Group.

In an interview with Medtech Insight, co-author of The Digital Pill, Elgar Fleisch proselytized the benefits of digital health, explaining how particular innovations could solve problems in health care.

Stephanie Kent is now CEO of Carbon Medical Technologies and DiFusion Technologies has appointed two new board members.

MedTech Innovator has announced the 50 companies competing in its annual Showcase and Accelerator program, which will culminate at The Medtech Conference in September, where the winners will be awarded a $350,000 prize.

US regulators say Verily’s Study Watch – meant to be used in Parkinson’s trials – doesn’t collect data needed to assess whether a patient is truly benefitting from a drug.

April and May were full of cardiovascular professional society conferences, yielding important new research results along with announcements of major new clinical trials. Here are a few of the highlights.

In this week’s podcast, Medtech Insight's UK-based reporter Barnaby Pickering provides an update on Medtronic’s MiniMed 780G insulin pump cost-savings study, presented at the Advances Technologies & Treatments for Diabetes (ATTD) conference. US Commercial and R&D manager, Reed Miller, highlights details on CVRx’s recent IPO.

The funds will support expanded commercialization of the company’s baroreflex activation stimulation technology to treat heart failure in patients with a low left-ventricular ejection fraction.

The 17 September session will home in on the details of spinal device regulation, including adverse event reporting and efforts to increase diversity in study populations.