Much-awaited draft guidance on quality expectations for EU marketing authorization applications for integral and other types of drug-device combination products is due to be published for public consultation shortly. See what the European Medicines Agency's Armin Ritzhaupt said about it here:

FDI in India's medtech sector has plunged to levels last seen before investment in the sector was liberalized and the Indian association representing global medical technology firms says government-imposed price controls are to blame.

TÜV SÜD, headquartered in Germany, is the second notified body to be officially designated under the EU MDR. Is this good news going to significantly lessen medtech industry’s concerns over delays in accessing the new, tougher regulatory system for medical technology, with time running seriously short?

To what extent would a no-deal Brexit from the EU threaten the future of clinical investigations being carried out in the UK? Sarah Sorrel and Sabine Koudsié of MedPass International explain.

The US FDA is warning diabetic patients that using unauthorized devices and unauthorized algorithms could have serious consequences. This comes after a patient who used such devices nearly died. See what the agency said about the serious adverse event here:

Industry has been hammering away the message that the medtech system is heading for crisis. A fallback plan is under review as authorities share industry’s concerns. Authorities are considering reviewing some products, among other solutions.

The US FDA will turn the lights out on its 22-year-old Alternative Summary Reporting Program for adverse events at the end of May, the agency tells Medtech Insight. But it's the FDA's upcoming online release of millions of summarized Medical Device Reports sent to the agency between 1998 and 2017 that could have the tongues of industry – and the public – wagging.

The US FDA has released a new batch of information from its ongoing postmarket surveillance of Bayer’s Essure birth control device. Last year saw the number of Medical Device Reports filed about the device revert to historic norms, while more progress was made in shaping the ongoing Sec. 522 postmarket study.

The US FDA's Office of Regulatory Affairs – which handles all of the agency's field activities – is "sitting on a lot of vacancies right now," FDA official Jan Welch said at MedCon 2019. Here's what ORA wants to do to nab and retain staff, and plan for the next generation of senior supervisors.

In this edition of Medtech Tips, Ilya Kazi, a partner at intellectual property firm Mathys & Squire LLP, provides top tips on what medtech businesses should do in order to help protect their IP and avoid risks to their inventions. 

The worldwide market for surgical heart valve products is expected to stay relatively flat, reaching $2bn in sales by 2023. The heart valve repair and replacement segments are expected to see small losses while the much smaller PBV systems market will grow at a CAGR of 12.7% by 2023, benefiting from a trend toward minimally invasive procedures.

Cloud-based software company Veeva wants to grow it business in medical devices to meet industry demand for better data management systems. The company is already a major provider of software services to the pharmaceutical industry.

Digital health technologies can help cardiology practices and departments and hospitals meet the growing demand of improving care quality and patient outcomes,according to Alexis Bernstein, Senior Director of Client of Strategy and Operations at Wellframe, a Boston-based health information technology company.

Acutus announced a deal to acquire Rhythm Xience, and new strategic partnerships with Peerbridge Health, Cardiac Designs and MedFact, to offer more electrophysiology products that complement its AcQMap multi-electrode electrophysiology mapping catheter system.

Alexander Weber, assistant professor of Sports Medicine in the USC Department of Orthopedic Surgery, told Medtech Insight that suture anchors have benefitted from technological advancements. Check out his comment here.

In this edition of Device Week, Medtech Insight's Catherine Longworth reports on her experience at the BIOMEDevice meeting in Boston, where she talked to CEO Scot Huennekens, the former CEO of Verb Surgical, the robotics start up formed by Google and Johnson & Johnson’s Ethicon. Verb is combining robotics, advanced instrumentation, advanced visualization, data analytics and machine learning to create a platform for digital surgery, rather than trying to compete with the existing surgery robotics companies like Intuitive Surgical.

In a 21-patient first in-human pilot trial, Medtronic’s Extravascular Implantable Cardioverter Defibrillator (EV ICD) system successfully terminated induced ventricular arrhythmias in 89.5% of patients and achieved pacing capture in 95% of patients.

The National Institute for Health and Care Excellence recommends that UK’s National Health Service adopt Smith & Nephew’s PICO negative wood dressings as an option for closed surgical incisions in high-risk patients.

Abbott has agreed to provide directional deep brain stimulation, spinal cord stimulation, and dorsal root ganglion therapy devices to help NIH study treatments for chronic pain and progressive movement disorders like Parkinson's disease.

Results of the TREAT AF trial showed low-level transcutaneous electrical stimulation of the auricular branch of the vagus nerve through the tragus of the patient’s ear reduced atrial fibrillation burden over six months.

There have been no adverse events reported from the first 30 laparoscopic surgeries performed with CMR Surgical's robotic platform Versius in a hospital in India.