The impending implementation of the EU's new Medical Device and IVD Regulations will cause most firms to pull select legacy devices and in vitro diagnostics from the EU market, a survey of 169 quality and/or regulatory professionals finds. The survey also revealed that companies are in hiring mode as the compliance dates for both regulations approach. Quality and regulatory officials from Abbott Laboratories and Meridian Bioscience weigh in.
Most manufacturers plan to stop selling at least one legacy product in the European Union after the EU's new Medical Device and IVD Regulations go into effect, a recent industry survey finds.
The survey of 169 people who work in quality and/or regulatory roles in medical device and IVD firms showed that...
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
US Medicare has proposed national coverage of renal denervation for patients with uncontrolled hypertension. The treatment is seeing other advances as well, with Medtronic piloting a longer catheter and a multi-organ approach and a blood test to identify the best candidates fresh on the
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.
The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
