The new EU Medical Device Regulation sets a high bar for medtech companies. Kaushal Solanki, founder of US-based Eyenuk, tells Medtech Insight how the firm navigated the new regulation and gained two extra indication approvals for its class IIb eye screening device.

The ENT specialist reportedly purchased only 36 single-use sinus devices but performed at least 1,400 procedures. She could land up to 40 years in prison after being convicted on 20 counts including device adulteration, conspiracy, and fabricating medical records. 

Widespread implementation of rapid diagnostic tests is critical for decreasing antimicrobial resistance. 

Recalls on a life-support device used during heart surgery and dialysis tubing were announced this week, as were approvals for a breast cancer companion diagnostic and two cardiac ablation catheters. Additionally, the US FDA has grants available for groups that assist in pediatric device development.

The omnibus spending bill passed at the end of 2022 requires clinical trial sponsors to submit a diversity action plan to the US Food and Drug Administration. Attorney Faraz Siddiqui, who coauthored a blog post on the new regulation, spoke to Medtech Insight about the requirement and the push to increase diversity.

The UK MedTech Directorate has issued its much-awaited medical technology strategy for improving supply resilience and encouraging innovative and dynamic markets and sector diversity.

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.

The new EU Medical Device Regulation sets a high bar for medtech companies. Kaushal Solanki, founder of US-based Eyenuk, tells Medtech Insight how the firm navigated the new regulation and gained two extra indication approvals for its class IIb eye screening device.

Widespread implementation of rapid diagnostic tests is critical for decreasing antimicrobial resistance. 

An interactive view of medtech executive changes from the month of January 2023, including GE Healthcare's new leadership as a standalone company.

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.

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.

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.