The US FDA released only one device-related close-out letters in January which went to a Michigan orthopedics firm.

The US Food and Drug Administration published three device-related warning letters in January – two that went to divisions of endoscope vendor Olympus, and one to a Maryland vision treatment firm.

ECRI says gaps in communication about recalls of medical devices used at homes pose a significant risk to patients. The nonprofit safety organization’s list of the top ten technology hazards for 2023 put lack of communication at the top.

Following Sterigenic’s $408m EtO settlement, a securities class action lawsuit has been filed against its parent company Sotera Health Company.

Products like laser pointers, gun sights and lasers used to align machinery fall under a new guidance document from the US FDA, which details the limits on how much radiation these products may emit.

One outcome of last year’s public consultation on UK MHRA fees is a hefty uplift in charges payable by medtech manufacturers in 2023, beyond which the agency is keen to pursue a new fees and charges plan.

After a lengthy inspection of a Philips facility that manufactured several recalled breathing and ventilator devices, the US Food and Drug Administration delivered a pointed report to the company highlighting multiple risk management and quality systems issues. In response, Philips wrote to the FDA outlining steps it plans to take to fix the problems.

A recent webinar ranking last year’s best and worst legal verdicts said that product liability cases involving pelvic mesh and artificial lenses were the very worst. 

Medtech Insight spoke to Sidley Austin LLP partner Jeff Senger about the challenges companies may face navigating the FTC’s updated health products guidance.

Sequana Medical is simultaneously developing both drug and device treatments for fluid overloads in the body. Medtech Insight spoke to the company’s CEO about their trials and the challenges of raising cash in 2023.

After an admittedly difficult 2022 for a variety of reasons, Philips Healthcare is ready to tackle 2023 and beyond by reducing business complexities, slimming staff numbers further and crucially implementing a new value creation strategy under recently appointed CEO Roy Jakobs.

After years of underfunding, stigmatization and lack of research, companies working on products and services that address women’s health care are gaining traction. But the sector also faces unique challenges, such as gaining approval for ads on major social media platforms.

There are fewer than a handful of prescription video game digital therapeutics with regulatory clearance, but gamification in patient care is proving its worth as a novel way of treating a range of conditions, from vision loss to dyslexia and ADHD. Now, the onus is on lawmakers and insurers to create a clear path towards reimbursement.

The company has developed a technology that uses engineered DNA to reprogram cancer cells, forcing them to produce substances that could be used to help image, detect or even destroy them.

Abbott said a major competitive benefit of the Proclaim XR SCS system is the battery life of up to 10 years at low settings.

After years of underfunding, stigmatization and lack of research, companies working on products and services that address women’s health care are gaining traction. But the sector also faces unique challenges, such as gaining approval for ads on major social media platforms.

Abbott said a major competitive benefit of the Proclaim XR SCS system is the battery life of up to 10 years at low settings.

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb provides highlights from the recent CES 2023 conference in Las Vegas. Reed Miller discusses Abbott’s VR partnership with the Blood Centers for America and Barnaby Pickering highlights Bayer’s jump into medtech with its buyout of Blackford Analysis.

In this final roundup of innovative health technologies showcased at CES 2023, Medtech Insight highlights three companies, Biobeat, Conneqt and Valencell, that are developing innovative technologies for cuffless blood pressure monitoring. Biobeat is the first company to receive US FDA clearance for a wearable to monitor blood pressure, but competition looms.

Shockwave, which markets lithotripsy technology to treat calcified vascular disease, will pay about $100m upfront and up to $47m more in potential milestones to buy Neovasc, the Vancouver, BC-based developer of the Reducer device to treat angina.

In this second roundup of innovative health solutions showcased at CES 2023, Medtech Insight highlights SK Biopharmaceuticals’ new wearables in development for early detection of seizures, Dassault Systèmes’ simulated 3D heart, and Lighthouse Tech’s eyewear to help the visually impaired detect obstacles.