FDA releases top 3 medical device regulation goals

FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today. The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices.

Is tax reform good or bad for medical device companies?

Medical device companies and others in the healthcare sector stand to benefit from the tax reform Congress passed at the end of 2017, but the picture isn’t entirely rosy, according to a new report from S&P Global Ratings. In many ways, the report offers a corrective to the bullish statements coming from corporate CEOs such

FDA needs to improve medical device regulation, GAO says

FDA is lacking performance metrics when it comes to tracking whether its medical device regulators are following a “least burdensome” approach toward asking applicants for additional information, according to a new report from the U.S. Government Accountability Office. The GAO says in the report highlights: “Until such measures are developed and used, FDA will not

Secant Group officials think they’ve cracked vascular regeneration: Here’s how

Secant Group today announced what it described as game-changing technology to advance vascular regeneration, solving problems that surgeons presently have when it comes to vascular harvesting and the non-resorbable synthetic graft compliance mismatching. The technology, which Secant (Telford, Pa.) developed in partnership with its sister company SanaVita Medical, involves a synthetic, small bore, vessel with a

Northwire expands biocompatibility compliance

Northwire (Osceola, Wis.) announced that it has finished additional testing to certify its BioCompatic material line to be in accordance with ISO 10993-10 irritation and skin sensitization requirements. The company’s BioCompatic material is designed to create optimized, safe and dependable medical cables while meeting biocompatibility standards under USP Class VI and compliance to ISO 10993-5 cytotoxicity.

Abbott, Nevro tout spinal cord stimulation tech

Abbott (NYSE:ABT) and Nevro (NYSE:NVRO) touted their spinal cord stimulation technologies at the annual North American Neurological Society meeting in Las Vegas. Two-year data from Abbott’s 42-patient Sunburst study revealed that a majority of patients chose its BurstDR therapy when given the choice during the long-term follow-up period and that stimulation from BurstDR provided pain relief […]

Light-based medical products: What you need to know

Photonics technologies are everywhere but need a deft touch to integrate into light-based medical products. Scott Wohlstein, The Photonics Group Much like electronics is the study of the electron, photonics is the study of the photon and includes its generation/emission, transmission, detection and analysis. Incandescent/fluorescent light sources, UV lamps, lasers, LEDs, lenses, fiber optics, detectors

How laser marking could solve the medical device industry’s UDI challenges

Here are five ways that laser marking could provide advantages to medical device companies when it comes to meeting permanent marking requirements under FDA’s Unique Device Identification program. Ashir Thakore, SABIC As the U.S. Food and Drug Administration (FDA) implements its phased Unique Device Identification (UDI) program across medical device classes, OEMs are considering methods

FDA warns BD over blood collection tubes used in Magellan’s lead testing kit

The FDA issued a warning letter to Becton Dickinson & Co. (NYSE:BDX) today, citing a number of violations of federal law that it identified in an inspection of the company’s New Jersey facility. The inspection, which was done as part of the agency’s ongoing investigation into the cause of inaccurate blood lead tests linked to Magellen […]

J&J chief Gorsky bullish on tax reform, plans $16B in repatriated overseas cash

Johnson & Johnson (NYSE:JNJ) chief executive Alex Gorsky is bullish on the newly passed US tax reform, according to a new interview with CNBC. Gorsky said that with the passing of the new tax reform bill last month, New Brunswick, N.J.-based Johnson & Johnson plans to repatriate $16 billion in overseas cash, according to the interview. […]

BioSig set to scale up operations

BioSig recently announced that it has partnered with Charles Austin and JK partners to start scaling up its operations to prepare for the commercial launch of its Pure EP system. Pure EP is meant to improve the quality of clinical information coming out of electrophysiology studies and cardiac catheter ablation. Austin has over 25 years

Bringing medical device manufacturing back to the U.S.: Here’s how it’s done

Here’s an inside look at one organization’s decision to bring medical device manufacturing back onshore. John Thomas, Bonifacio Consulting Services Deciding where and how to manufacture a product is without a doubt one of the most important decisions a medical device OEM faces. This decision has many implications, from the overall successful manufacture of the product

3 ways the medical device industry could evolve in 2018

Continued M&A, investment in long-term innovation, transforming business models – those are some of the ways the medical device industry could evolve this year, according to Jeff Greene, EY’s global life sciences transaction advisory services leader. EY today released its 2017 M&A Firepower Report: Life sciences deals and data, which analyzes three life sciences subsectors: biopharma, biotechnology

Medical device companies: These 15 performed the best in 2017

Updated Jan. 5, 2018 Among the most successful medical device companies of 2017, there were two themes: innovation and breadth of services. That was the major takeaway of an MDO analysis of the stock performance of the 100 largest publicly traded medtech companies in the world. What does innovation mean? Think Align Technology (Nasdaq:ALGN) and

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Stroke treatment: There’s a simple way to improve it in the U.S.

Technology is already available to greatly improve outcomes for people suffering from strokes, but the present healthcare system is standing in the way of people getting it, according to Stacey Pugh, VP and general manager of the neurovascular unit at Medtronic. The most important thing that could boost stroke treatment is passing proper legislation about