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.

The topical treatment is made from human skin cells and can be applied to speed the healing of deep thermal burns.

A petition submitted to the US FDA seeks to exempt class II powered patient-transport devices from premarket notification requirements.

Company CEO Michael Perry spoke with Medtech Insight about Avita Medical’s spray-on-skin system and his hopes for the product.

‘JAMS’ has been strengthening the European market surveillance network and helping lower-resourced member states develop skills and capacity. Coordinated pilot project work is next.

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.

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 US FDA’s updated regulatory agenda says the agency will release a draft of its revised QSR in June 2021. But industry has seen this song and dance before – so will the FDA finally deliver the goods this time?

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.

The company is commercializing technology developed at Dartmouth and Stanford universities, hoping that its technology will reduce the size and complication rates of implantable devices.

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.