Deaths prompt Abbott recall of Thoratec HeartMate II controllers

Brad Perriello, Executive Editor Abbott (NYSE:ABT) is recalling nearly 29,000 controllers for the HeartMate II implantable heart pump made by its Thoratec subsidiary after 26 patients died trying to change out the controllers on their own. The March 29 recall of 28,882 controllers for the HeartMate II left ventricular assist device follows 70 reports of

Trump proposes deep cuts to Medicaid, NIH funding

President Donald Trump’s proposed budget would slash Medicaid funding and cut support for major biomedical research programs at the National Institutes of Health and the Centers for Disease Control & Prevention. The budget blueprint drew condemnation from healthcare advocates and lawmakers from both sides of the aisle. Senate majority whip Sen. John Cornyn (R-Texas) reportedly said earlier

Why adding device identifiers to insurance claims protects patients

The pushback to adopting unique device identifier into claims forms is that the added steps will be burdensome for hospitals. But documenting device identifiers in claims forms is actually “feasible” and “straightforward,” and requires only modest effort, according to a new whitepaper from Boston’s Brigham and Women’s Hospital. Of particular concern was that the device claims

Patient preferences increasingly affect FDA decision-making: Here’s how

Tobi Laczkowski, ZS Associates Patient empowerment is manifesting itself in many forms across the healthcare landscape, and the influence of patient preferences on medtech approvals is growing. As a primary stakeholder – the end user – for medical devices, the patient is playing an increasingly significant role in FDA approvals. Over the past several years,

China regulators formalize procedures for medical device expert panel meetings

By Stewart Eisenhart, Emergo Group Regulators at the China Food and Drug Administration (CFDA) have published formal procedures for expert panel meetings held to discuss medical device registration issues, clarifying the process for Chinese market applicants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the

Eurasian governments progress on unified device regulatory system

By Stewart Eisenhart, Emergo Group Regulators in five Eurasian countries report progress in efforts to establish a harmonized medical device market that would incorporate Russia, Armenia, Belarus, Kazakhstan and Kyrgyzstan. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily

European medical device and IVD regulations officially published

By Stewart Eisenhart, Emergo Group The European Commission has officially published the Medical Device Regulations (MDR) 2017/745 and In Vitro Diagnostic Regulations (IVDR) 2017/746 on May 5, 2017 in the Official Journal of the European Union (OJEU). The MDR will replace the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive

Common audit problems: Publishing audit reports

By Stewart Eisenhart, Emergo Group In the final installment of Emergo’s blog series on medical device quality management system audit problems, we examine the audit report publication process and related challenges. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not

Abbott lands French reimbursement win for FreeStyle Libre glucose monitor

Abbott (NYSE:ABT) said today it won national reimbursement from the French Health ministry for its FreeStyle Libre wearable glucose monitor. The FreeStyle Libre is designed to monitor glucose through a sensor worn on the back of the upper arm for 2 weeks, without the need for the finger prick calibration required by continuous glucose monitoring

China FDA clarifies device recall requirements

By Stewart Eisenhart, Emergo Group Chinese medical device market regulators have made reporting forms necessary for recall management available online. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

Brazilian INMETRO certifications compliance deadline stays

By Stewart Eisenhart, Emergo Group Brazilian regulators are leaving in place the latest deadline of May 1, 2017 for new INMETRO certification requirements for some medical devices, despite extending this deadline twice in the past. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s

New Brazilian sanitary licensing regulations for medical device companies

By Stewart Eisenhart, Emergo Group Brazilian medical device market regulator ANVISA has implemented new risk-based requirements for domestic companies to obtain sanitary licenses. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

Wading into parallel reviews as a reimbursement strategy

The process of gaining reimbursement is one of the most expensive and perilous activities a medical technology company will undergo. Some are exploring how (and whether) a strategy that encourages working with both FDA and CMS at the same time can help cut down the resource costs associated with reimbursement. Seth Goldenberg, director of product

UK medical device regulators replacing OBL with ‘virtual manufacturing’

By Stewart Eisenhart, Emergo Group Recent guidance from the Medicines & Healthcare Products Regulatory Agency (MHRA), the UK’s medical device market regulator, establishes the term “virtual manufacturing” to replace Own Brand Labeling (OBL) used by companies that place their names on devices made by other manufacturers. Get the full story here at the Emergo Group’s

Medtech stories we missed this week: April 28, 2017

From FDA and Health Canada approvals to joint ventures, here are medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Joimax Endovapor 2 Joimax announced in an April 26 press release that it has received FDA 510(k) clearance to market its Endovapor 2 Multi-Radio Frequency System. The device generates