The US FDA has designated GE Healthcare’s recall of its CARESCAPE R860 ventilator as Class I, the agency’s most serious category.

EURLs have been a critical missing element of the IVDR for assessing the higher-risk class D IVDs. Two new implementing regulations, on fees and tasks, bring them closer to designation.

In its just-released real-world evidence framework, NICE assesses the role and value of data collected outside highly-controlled clinical studies in driving more innovation towards health care professionals.

Ukraine’s medical supply needs have evolved since Russia launched its military invasion of the country on 24 February. EU healthcare decision makers and the medical technology industry have since stood firm in their support of the besieged country, said MedTech Europe’s Jesús Rueda.

The recent COVID-19 lockdown in Shanghai caused widespread disruption locally and an economic slowdown for China. But it did not interrupt the ongoing digitization of health care, the value of which was once again thrown into sharp relief, writes news and analysis portal Omdia.

The devaluation of the Turkish Lira since May is making imports of medical devices more expensive and putting hospital procurement under renewed pressure. The local medtech industry associations TUMDEF and ARTED describe the problems  ̶  and the solutions  ̶  to Medtech Insight.

The US FDA has designated GE Healthcare’s recall of its CARESCAPE R860 ventilator as Class I, the agency’s most serious category.

EURLs have been a critical missing element of the IVDR for assessing the higher-risk class D IVDs. Two new implementing regulations, on fees and tasks, bring them closer to designation.

The US FDA has published its final guidance for premarket submissions of radiological devices that use quantitative imaging – technology which offers clinicians a more accurate picture of a disease.

COVID-test maker Cue Health said it laid off 170 people in its manufacturing facility but remains “confident in its long-term strategy.”

The US FDA has designated GE Healthcare’s recall of its CARESCAPE R860 ventilator as Class I, the agency’s most serious category.

SonALAsense has received Safe to Proceed letters from the FDA to begin trials of its ultrasound-activated cancer killing drug.

Local newspapers in Chicago confirm that Abbott is leasing space in Chicago’s most famous building in an attempt to better serve employees who live closer to the city than its Lake County, IL, campus.

Nothing except a name, but Creo Medical says its Speedboat Inject device can turn some surgeries from prolonged hospital stays into one-day visits.

In this episode of Report Digest, UK-based reporter Barnaby Pickering speaks to analyst Mike Carmody about Meddevicetracker’s recent report on deep brain and Vagus nerve stimulation. The two discuss market players, recent tech developments and future potential for the market.

In this month’s Digital Health roundup, Medtech Insight’s Marion Webb discusses her deep-dive article on menopause with leading experts in this rising industry and Barnaby Pickering highlights UK-based Proximie, which developed a web-based platform that allows surgeons and other clinical experts to collaborate virtually in the operating suite. The company recently raised $80m in a series C round.

This edition of Medtech Insight’s Cardiovascular Catch-Up features highlights from recent interviews with leaders of some not-so-famous companies addressing cardiovascular health from a variety of angles – from improving the traditional stethoscope to non-invasive 3D mapping of arrhythmias and more.

Epic Sciences spoke to Medtech Insight to discuss the development of its DefineMBC test for metastatic breast cancer.

Sensonics received the CE mark for its next-generation E3 CGM with plans to launch in the third quarter. It will be facing stiff competition from CGM makers Dexcom and Abbott in the European market. 

Medtech Insight’s Cardiovascular Catch-Up highlights recent news on cardiovascular tech innovations in the last two months. Part II of this month’s update includes innovative research and development news from smaller companies and research labs that you may have missed.

Medtech Insight’s Cardiovascular Catch-Up highlights some of the recent news on cardiovascular tech innovations in the last two months. This edition focuses on news from conferences, held over the last two months, including the Heart Rhythm Society and the TVT Structural Heart Summit.