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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Healthcare IT funding hits record $5.1 billion

Global funding for healthcare information technology and digital health companies hit record levels last year, according to the latest annual report from Austin, Texas–based Mercom Capital Group. There were a record 622 deals worth $5.1 billion in 2016, up from 574 deals worth $4.6 billion in 2015, according to Mercom Capital Group. The amounts involve

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

Medtec Report: China increases focus on med device development

Regulators in China are looking to promote and increase the localization and development of medical devices in the region and grow the market significantly, according to a report from industry group Medtec. China released its 13th 5-year health strategy plan, drawing a bead on medical devices as a “main breakthrough area” for the country, according to

FDA introduces IMEDS, a public-private resource for evidence generation

Dr. Robert M. Califf FDA has been working to establish a national resource for FDA-approved medical products that can be used by public and private-sector entities, including regulated industry, to conduct large scale evaluations of safety issues in an environment that is secure and protects patient privacy. These evaluations include epidemiologic studies of medical products

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

Whale Imaging launches G-Arm Duo imaging system

Whale Imaging, leading designer and manufacturer of the  G-Arm and Sigma Series ultrasound medical imaging systems, announced FDA 510(k) clearance of the G-Arm B6 Duo. The B6 Duo is the next generation of the G-Arm with major improvements including axial tilt and greater table access. “We’re thrilled to be launching this sooner than our original

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.

Eyewear giants Essilor, Luxottica to merge

Italian eyewear maker Luxottica (NYSE:LUX) and France’s leading lens manufacturer, Essilor (EPA:EI), have reached a €46 billion ($49 billion) agreement to merge and create a global eyewear company with annual revenue of more than €15 billion. “Finally … two products which are naturally complementary—namely frames and lenses—will be designed, manufactured and distributed under the same

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