Health Canada has published a guide for manufacturers planning to import medical devices into the country. New procedures and advance notice are required under the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), which Canada ratified in 2018.

Australia is proposing to introduce new medical device software rules that would result in a number of changes for industry. Health Canada, meanwhile, has developed a draft guidance for software as a medical device to better define the regulatory compliance requirements for emerging technologies.

Despite a recent report that Sen. Amy Klobuchar, D-Minn., is backing away from leading efforts to repeal the medical device tax due to her presidential ambitions, sources say she is working with Sen. Pat Toomey, R-Pa., to cosponsor a repeal bill this year. Similarly, on the US House-side, Rep. Ron Kind, D-Wisc., is calling on his colleagues to support a full repeal bill as well.

The EU Medical Device Regulation is 15 months away from being implemented in full, and a new German survey about its potential impact on the medtech innovation and patient-care landscape makes for sobering reading.

India is now allowing medical device companies to submit their instructions for use (IFU) in electronic format. See what Pavan Choudary from the Medical Technology Association of India said about it here.

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

A clear, succinct problem statement is the backbone of a winning device failure investigation, Karl Vahey says. He notes that a well-developed statement is also useful to have on hand when regulators conduct a facility audit and review corrective and preventive action (CAPA) activities.

The upcoming voluntary global standard F3306 aims to improve the safety of surgically implanted medical devices. F3306 describes a novel test method that assesses metal and other ions released from single-use, metallic, implantable devices, and their components.

While the number of recalled products fell 1% in the fourth quarter of 2018, the number of recalled device units spiked dramatically. Machine failure was the top recall cause based on units, while software was blamed for causing the most recalled products for the 11^th consecutive quarter. Check out our Q4 recalls infographic.

Frost & Sullivan expects the "Femtech" market to reach $50bn by 2025. Reproductive health and menstrual health trackers rank among the fastest-growing sectors. See what Portfolia's Trish Costello said about it here.

Thoratec has agreed with plaintiffs to pay $12m to settle a lawsuit alleging the company hid negative information about the company’s heart pump, thus keeping share prices artificially high. A hearing is scheduled on the settlement for next month.

US FDA recently granted Cognoa’s autism diagnostic device a Breakthrough Device designation to accelerate its efforts to get the first FDA-cleared medical device for the early diagnosis of autistic spectrum disorder (ASD) to market. The average age of ASD diagnosis is about four years old, but extensive clinical research has shown that earlier diagnosis of ASD can improve outcomes over the child’s lifetime. Cognoa’s system is intended to allow primary care physicians to diagnosis ASD in the children as young as 18 months.

An experienced board member steps up to fill the CEO slot at neurostim firm Nuvectra; a new CFO is taken on board at osteobiological products company Biogennix; and Microbot Medical's chief operating officer resigns.

Femtech, which describes digital technologies that aim to improve women's health, is expected to reach $50bn in market size by 2025, according to Frost & Sullivan. Reproductive health and menstrual health trackers are two of the fastest-growing sectors in femtech. We've highlighted some of the biggest players in both segments, their innovative business models, plans and also looked at barriers such as privacy issues, accuracy of mobile applications and funding challenges.

Edwards Lifesciences has made its first acquisition since 2017, inking a $100m deal to buy monitoring technology company CAS Medical Systems.

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, two spine device approvals from US FDA, and a CE mark for a new drug-eluting stent.

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering Feb. 1 through Feb. 10, includes published results from trials of Global Kinetics’ Personal KinetiGraph movement recording system for Parkinson’s disease patients, Milestone Scientific’s CompuFlo Epidural System for epidural-block anesthesia, and Leviticus Cardio’s wireless Coplanar Energy Transfer system for left-ventricular assist devices.

Results of a study published in December found that left-side circulatory support with an Impella pump was not associated with lower 30-day mortality compared with matched cardiogenic shock patients treated with an intraaortic balloon pump (IABP) or medical therapy.

FDA sent a letter to physicians alerting them to interim results from the post-approval study of Abiomed’s Impella RP right-heart pump system that suggest a higher mortality rate for patients than what was observed in pre-market studies. FDA believes the benefits of the Impella RP system continue to outweigh the risks for patients covered by the currently approved indication; it emphasizes to physicians the importance of early placement of Impella RP, and the importance of following proper inclusion and exclusion criteria when selecting patients. The results cited by FDA were announced about two months after results of a non-randomized study in Germany cast doubt on the benefits of Impella for left-sided support in cardiogenic shock patients.

An Alzheimer’s treatment device from Israeli firm Neuronix Ltd has landed a date with US FDA’s Neurological Devices Panel. The committee will discuss the neuroAD Therapy System on March 21.

This week's edition of Medtech Insight's Results Recap, the weekly roundup of major device trial results from MedDeviceTracker, includes medical device trial results announced from Jan. 25 through Jan. 31. After a flood of data last week from the Leipzig Interventional Course (LINC), this week’s list has just two entries: Medtronic announced new results supporting the long-term durability, safety, and efficacy of its Valiant Captivia thoracic stent graft system for the treatment of blunt thoracic aortic injury and Levita Magnetics announced the publication of a retrospective review of 73 bariatric procedures with its Levita magnetic surgical system.