Donald Trump: 5 questions medtech needs to ask

From tax breaks to Obamacare repeal, medtech companies are likely due to experience major changes under President Donald Trump. The situation, though, remains unpredictable. “I don’t think that there has been a scenario, not since I’ve been a professional and in politics, where we really know so little about exactly what the key priorities are

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FDA Advisory Committees: Independent, Informed, Essential, and Evolving

By: Robert M. Califf, M.D. One of the most common concerns raised when I meet with medical leaders is the need to improve the function of FDA’s Advisory Committees (ACs). ACs play a key role in FDA’s decision-making process by providing independent expert advice on extraordinarily complex issues. Just as importantly, they offer a forum

Trump’s HHS pick defends ACA repeal and replacement

President-elect Donald Trump’s nominee for Health and Human Services Department secretary—Rep. Tom Price (R-Ga.)—maintained during a Senate committee hearing on Wednesday that the incoming administration wants to make sure everyone still has access to health insurance after an ACA repeal. But Price also presented a radically different version from the Obama administration when it comes to

Intact Vascular wins CE Mark for Tack blood vessel repair device

Intact Vascular said today that it won CE Mark approval in the European Union for its Tack endovascular system to repair arterial dissections after percutaneous transluminal angioplasty below the knee. The indication extends the system’s use in the EU to the tibial arteries between the knee and the ankle. The Tack implant can be used in arteries ranging from

U.S. medical device approvals: Pitfalls you need to avoid

Companies that are strapped for time and cash would do well to understand exactly what the agency wants and avoid unnecessary pitfalls, says Michael Lynch, managing consultant at Intertek. (Lynch will be presenting a straightforward webinar on Jan. 31, at 2 p.m. Eastern time: “5 Steps to Medical Device Commercialization in the U.S.”) “FDA is

Physio-Control has a battery problem with its LifePak 1000 AED

Physio-Control said last week that it is launching a voluntary field action for its LifePak 1000 defibrillator, after reports that the device can shut down unexpectedly during treatment. The Redmond, Washington–based company has received 34 reports describing instances when customers have attempted to use the LifePak device and it has shut down due to an

FDA warns again on Pentax duodenoscopes

The FDA issued a statement today warning that Hoya (TYO:7741) subsidiary Pentax Medical’s ED-3490TK video duodenoscopes have a potential risk associated with the design and manufacturing of the device. Cracks in the adhesive that seals the scope’s distal cap and tip can lead to microbial and fluid ingress, according to information provided to the FDA by Pentax.

South Korean medical device regulatory changes updates

By Stewart Eisenhart, Emergo Group Enforcement dates for various new and updated medical device regulations in South Korea have now gone into effect, according to Emergo consultants in Seoul. 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

The ACA is going to die: Why is medtech so quiet?

Some major medical device industry lobbying groups are staying mum for now about the expected repeal of the U.S. Affordable Care Act—even though an extensive overhaul of the national healthcare system would have a serious impact on medtech. With so much unpredictability around how the incoming Trump administration and the new Republican Congress will replace

Medical device reporting: your burning adverse event questions answered

Tom Middleton, Solutions Architect, Sparta Systems In November 2016, FDA released its final guidance on medical device reporting (MDR). MDR has been an intrinsic part of the medical device regulatory process for many years. There’s no specific change or new information in this document, but it does answer some fundamental questions about when and how

FDA: St. Jude Medical devices really do have a cybersecurity problem

FDA issued a safety communication on January 9, 2017, detailing St. Jude Medical products that could be vulnerable to cyber threats. These threats could result in rapid battery depletion or administration of inappropriate pacing or shocks—potentially lethal outcomes. FDA noted that there have been no reports of patient harm related to the cybersecurity risks. The news comes

FDA’s CDRH reveals guidance plans for FY2017

CDRH is setting its goals along with the rest of us for the new year. The agency has published and prioritized its intentions for FY2017, starting with a list of new documents it intends to release in FY2017 (A-list). It has also shared a B-list of previously-issued final guidances for which CDRH would like feedback,

Regulatory and Quality Solutions certified by Women’s Business Enterprise National Council

Regulatory and Quality Solutions (R&Q), provider of industry-leading regulatory and quality consulting and engineering services to medical device companies, is proud to announce national certification as a Women’s Business Enterprise by the Women’s Business Enterprise Council-PA-DE-sNJ, a regional certifying partner of the Women’s Business Enterprise National Council (WBENC). The designation signals a competitive advantage for

TransPerfect: Here’s how device manufacturers can leverage UDI

TransPerfect Medical Device Solutions and 121nexus announced an update to the EnCompass system for content automation and distribution. The updated system is designed to cut labeling cost, risk, and turnaround by 50%, identify and eliminate mislabeled products and provide device users with easy access to digital information and direct product ordering. In September 2016, the

Mobile medical carts could have battery fire problems

U.S. FDA is warning health providers that battery-powered mobile medical carts could be a fire hazard. The agency has received reports of explosions, fires, smoking and overheating related to the carts, FDA said in its Dec. 27 letter to healthcare professionals. From January 2013 to July 2016, FDA received a dozen reports, an agency spokesperson