Two top trade experts tell Medtech Insight that China’s recent decision to reduce tariffs is in response to the US government’s announcement that it, too, would reduce tariffs in an apparent bid to deescalate the seemingly never-ending trade war. Dropping tariffs will also help China meet its obligations under a so-called Phase 1 trade deal agreed to by the two countries.

While the Trump administration’s proposed fiscal year 2021 budget for the US FDA would give the agency’s device center a 5.3% increase for medtech product approvals and safety, the center’s lofty plans to become the world’s premier regulator of new AI-driven gadgets, next-gen diagnostics and other novel devices means it will have to tap about $2.8m dollars usually set aside for staff training and outreach to help meet its ambitious goals.

The US agency says its medical device program is in desperate need of an information technology upgrade, noting that its outdated IT systems, tools and approaches could leave it flat-footed when dealing with cybersecurity threats and ever-evolving medtech. That’s why the FDA is asking Congress for $18m to tackle the IT sore spot.

No device-related warning letters were released by the US FDA the week of 12 February.

In this second article of a two-part series, Eithne Lee of ISO Life Sciences global consultancy identifies some of the problems that medtech premarket innovators and SMEs are facing, with the EU MDR application date now less than four months away.

The second in command at the US Centers for Disease Control and Prevention said with the help of the Chinese government, the agency was quickly able to develop a diagnostic test for the new coronavirus – but now the private sector should use its resources to scale up production of the tests.

The US agency says it missed critical goals for evaluating product recalls and so-called Code Blue Medical Device Reports (MDRs) in fiscal year 2019 – and it’s pinning the blame squarely on a massive reorganization of its device center. This isn’t the first time the FDA has pointed to the “super office” shakeup as a disruptor.

A mere 21 quality-related warning letters were issued to device makers last year, the US agency tells Medtech Insight. It’s the third year in a row that the FDA has given out a record-low number of letters. In fact, 2019’s count of 21 represents a whopping 83% decrease from just five years ago, when 121 letters were sent to companies.

News that device giant Cardinal Health recalled millions of potentially unsafe, unsterile surgical gowns – and a message out of the US FDA for customers to “immediately discontinue” using the gowns – was of most interest to our online readers last month. Meanwhile, the FDA’s plans to hasten emergency-use approvals of coronavirus test kits and a set of 10 tips for dealing with agency investigators also garnered significant attention. Here are January’s 10 most popular US policy and regulation stories from Medtech Insight.

Two top trade experts tell Medtech Insight that China’s recent decision to reduce tariffs is in response to the US government’s announcement that it, too, would reduce tariffs in an apparent bid to deescalate the seemingly never-ending trade war. Dropping tariffs will also help China meet its obligations under a so-called Phase 1 trade deal agreed to by the two countries.

Digital Surgery, a London-based developer of surgical artificial intelligence, analytics, digital education and training solutions, will join Medtronic’s surgical robotics business within its minimally invasive therapies group.

In this edition of Device Week, Medtech Insight's managing editor Marion Webb talks with deputy editor Reed Miller about his recent story on Abiomed's plan to counter unfavorable studies of its Impella heart pump.

[Editor's note: This article was updated on 14 February 2020 to clarify that Abiomed has invested more than $100m over the past five years in clinical research on the Impella heart pump platform. Abiomed has not committed to spend another $100m on new physician education and communication programs.]

Midmark, a dental and hospital equipment manufacturer, has a new CFO; CardioFocus promoted its president and COO to CEO; Toxys, an in vitro toxicity solutions firm, promoted top executives; and more.

Israel start-up Serenno Medical is planning a US launch for the Sentinel continuous urine output monitor for automatic monitoring and detection of acute kidney injury in patients treated in an intensive care unit. See what Serenno's CEO, Tomer Lark, said about it here.

The second in command at the US Centers for Disease Control and Prevention said with the help of the Chinese government, the agency was quickly able to develop a diagnostic test for the new coronavirus – but now the private sector should use its resources to scale up production of the tests.

The US FDA cleared Caption Health's Caption Guidance software, an AI package that guides users through cardiac ultrasounds to help them capture the best images. See what Caption Health's co-founder and president, Charles Cadieu, said about it here. 

The 50-patient SPYRAL DYSTAL trial will evaluate the benefits of a new targeted renal denervation approach with the Symplicity Spyral renal denervation system in patients with uncontrolled hypertension.

The Italian medtech industry association Confindustria Dispositivi Medici has launched a major survey of the activities and investment strategies of the sector’s almost 4,000 domestic developers and manufacturers.

Tendyne is indicated for the treatment of significant mitral regurgitation in patients who are not candidates for surgery. It complements Abbott’s MitraClip mitral valve repair device and is an important part of the company’s strategy to be the leading structural heart device company.

US regulators have cleared a suite of cloud-based artificial intelligence software intended to be used with Eko’s digital stethoscopes to detect certain heart problems. The company says the AI algorithms are the first of its kind to be cleared by the US FDA.

New research links the use of stents and balloons coated with the drug paclitaxel to an increased risk of lower-leg amputation shortly following surgery. The study was conducted by Greek researcher Konstantinos Katsanos, who previously found an increased mortality risk in paclitaxel-treated patients.