Expert panels will play a vital role in the implementation of the EU’s Medical Device Regulation, including in the oversight of higher-risk medical devices. At last, there are signs that they could be set up in time.

The first certificates have now been granted to medical device-manufacturers under the EU’s new regulations coming into force next year. Is this a sign that the whole sector is going to be on time to meet the requirements of the new Regulations? Or is it already too late?

Once the MDR is in force, current standards harmonized under the Medical Device Directive cannot be used to claim a presumption of conformity with specific requirements under the new Regulation. But updating these standards so they are harmonized under the MDR has hit a roadblock.

Device-makers with less-than-stellar compliance history may soon be able to join a variation of the program by the US Food and Drug Administration that assesses a company's manufacturing maturity and quality. See what Jeff Shuren, who leads the FDA's Center for Devices and Radiological Health, said about it here.

The US agency has released four updated guidance documents aimed at providing more clarity on how it intends to review 510(k) applications. The FDA says the guidances are intended to reduce unnecessary burdens for its review staff and to help sponsors avoid wasting resources. We break down each of the docs and explain what your company needs to know.

Medical device regulators around the world have proposed new guidance for designating conformity assessment bodies because requirements in existing international standards are too generic.

Device-makers that are shut out of the US agency's Case for Quality Voluntary Improvement Program (CFQ VIP) because of poor compliance histories may soon be able to join an alternative initiative that would use an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework to assess manufacturing maturity and quality.

In the only device-related warning letter released by the US FDA this week, the maker of Bounder wheelchairs was cited for premarket and Medical Device Reporting violations.

There were 200 recalls initiated by device-makers in the second quarter of 2019, a 22% increase over Q1, when 164 were reported. Conversely, the number of recalled device units fell from 135 million in Q1 to 19.7 million in Q2 – a decrease of 85%. Check out our Q2 recalls infographic.

Tel-Aviv, Isreal-based DreaMed Diabetes received another US Food and Drug Administration clearance for its AI-powered Advisor Pro software, which helps providers manage and optimize treatment for patients with type 1 diabetes. See what DreaMed's CEO, Eran Atlas, said about it here.

Quest Diagnostics and SomaLogic, a protein biomarker discovery and diagnostics company, will each bring on a new chief commercial officer; Immunexpress, a sepsis diagnostics firm, hired a VP for market development and commercial operations; and more.

Interventional cardiologists can expect important updates on transcatheter valves and drug-eluting stents during this year's late-breaking trials presented at the annual Transcatheter Cardiovascular Therapeutics meeting next week. They include updates from Edwards Lifesciences, Medtronic, Boston Scientific and Abbott.

UK robotics firm CMR Surgical landed $240m in a Series C financing round, which will propel its Versius robotic surgery system onto the market. See what CMR Surgical's CEO, Martin Frost, said about it here.

UK robotics firm CMR Surgical has landed $240m from investors as it prepares to launch its robotic surgery system in Europe and India. The Series C raise is Europe’s largest private financing round in the medical technology sector to date.

Seqster developed a technology platform that integrates data from electronic medical records, DNA and genomic information and fitness wearables into one place. See what Seqster's CEO, Ardy Arianpour, said about it here.

The first large randomized trial of drug-coated balloons to treat hemodialysis arteriovenous access stenoses showed Medtronic's IN.Pact AV paclitaxel-coated angioplasty balloon produces superior outcomes compared to standard angioplasty balloons. See what one of the trial’s primary investigators, Andrew Holden, said about it here.

Results of a study in over 11,000 patients shows Abbott’s MI³ algorithm can risk-stratify patients with suspected myocardial infarction and help doctors decide which patients are most likely to benefit from earlier clinical decisions.

The US FDA cleared a smartphone-based urine test for diagnosing chronic kidney disease. Israeli company Healthy.io developed the digital testing kit that enables smartphone cameras to act as clinical grade medical devices.

The In.Pact AV paclitaxel-coated balloon outperformed plain angioplasty balloons in the IN.PACT AV Access trial, the first large, multi-center randomized trial comparing a drug-coated balloon to standard balloon angioplasty in the treatment of hemodialysis arteriovenous access stenoses.

A meta-analysis that seemed to show an increased mortality risk tied to paclitaxel-coated balloons and stents sent shockwaves through the device industry last year. But a more complete data review funded by nonprofit group VIVA Physicians may show that the issue has been overestimated.

Dreem 2 is a biofeedback headband with seven sensors that measure brain activity, heart rate, respiration and movement that works with a mobile app to help users improve the quality of their sleep.