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

These nanosponges remove sepsis-causing bacteria from the bloodstream

California researchers have created a nanosponge that is designed to absorb and remove molecules that are known to cause sepsis. Researchers from the University of California at San Diego created macrophage nanosponges that are wrapped in the cell membranes of macrophages and can safely absorb and remove sepsis-causing molecules from the bloodstream. So far, the

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

3D printing and cryogenics could create new potential for artificial organs

Researchers at Imperial College London have developed a technique to replicate biological structures using cryogenics and 3D printing. The research is a first from the university to create structure that are soft enough to replicate the mechanical properties of organs like the brain and lungs. The 3D printing technique could create replica organs and assist

CES 2018: Medical technologies you need to know

Updated Jan. 16, 2018 Mobile health devices and wearables have increasingly played a prominent role at the annual CES show in Las Vegas. Health and medical devices touted at CES 2018 sought to improve everything from heart health to posture. Here are 13 companies that exhibited digital health solutions at this year’s show. Next >>

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How medtech could stop the drug overdose crisis in the U.S.

The opioid epidemic is one of the deadliest problems facing the U.S. today. Through the development of new pain management devices, medtech could be a leader in solving the crisis. The prescription opioid overdose crisis in America didn’t start until the late 1990s, when pharmaceutical companies touted prescription painkillers that weren’t supposed to be addictive.

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

This startup is bringing vision care to developing countries

PlenOptika, an MIT startup, has developed a portable autorefractor device that measures refractive errors of the eye and is able to estimate prescriptions in 10 seconds, bringing vision care to less accessible areas. The device, known as QuickSee, is more cost-effective than current technology and is currently on the market in India. “People at the

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 […]

How startup Nanowear partnered with Secant: It took a year and a lot of meetings

Nanowear, which creates cloth-based diagnostic monitoring nanosensor technology, has entered into an exclusive, worldwide supply-chain partnership agreement with The Secant Group for scaled manufacturing and production of its medical-grade cloth-based nanosensor technology. Under the agreement, Nanowear and The Secant Group will have the collective obligation for marketing the technology and associated products. Nanowear received FDA 510(k) clearance for its remote congestive heart

Tiny hair-like fibers help create interconnections between brain regions

MIT researchers have used a single flexible fiber about the size of human hair to deliver optical, electrical and chemical signals back and forth into the brain to create an improved way of learning about the functions and interconnections of different brain regions. The fibers replicate the softness and flexibility of brain tissue which allows

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. […]