The US Food and Drug Administration has designated a recall of Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps from Datascope/Getinge as class I due to the potential for the pumps to shut down during use.

The European Commission’s newly-launched Cancer Imaging Initiative will see sophisticated digital technologies based on artificial intelligence used to speed up medical innovations as part of its wider Beating Cancer Plan.

In an event hosted by the Medical Device Innovation Consortium, cybersecurity experts discussed a benchmark report on the state of cybersecurity in the device industry. The director of digital health product security policy at Medtronic previewed the updated Joint Security Plan.

A review of expert panel opinions related to high-risk medical devices shows no challenges yet by notified bodies to their findings.

Digital medical products pose challenges beyond the scope of existing evaluation frameworks for medical devices, triggering proactive responses at both a national and EU-level. A report by Belgian researchers shows just how complex the situation is.

DePuy Synthes reportedly provided a Massachusetts surgeon with more than $100,000 in free implants and tools.

The FTC has updated its guidance on health products advertising for the first time in 25 years with an expanded version that includes devices.

There had been handful of warning signals against well-known notified bodies designated against the MDR. Why were they there and why have they just been removed?

Damage to SMEs and innovation, overly high notified body costs and concerns over lack of surveillance for critical devices are all topics addressed among responses to the European Commission’s latest MDR proposal.

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 the first episode of Medtech Insight’s new podcast series focused on cardiovascular technology, editor Reed Miller talks to Steven Mickelsen, one of the founders of Farapulse and Field Medical, about pulsed field ablation, an emerging technology that is changing electrophysiology.

Listen up! In this episode of Medtech Monthly, Eargo CEO Christian Gormsen discusses the newly created OTC category for hearing aids. 

The FTC has updated its guidance on health products advertising for the first time in 25 years with an expanded version that includes devices.

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.

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.

The annual J.P. Morgan Healthcare Conference includes presentations from major medtech companies; Some use the conference as a platform for major announcements while some just take the opportunity to explain their 2023 outlook to investors. Here are some of the highlights from the presentations on the third day of the meeting.