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.

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

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 >>

Pages: 1 2 3 4 5 6 7 8 9 10 11 12 13 14

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

Teleflex Medical launches new suture technology to reduce tissue strangulation

Teleflex Medical has created a new suture technology that may reduce tissue strangulation and a cutting effect in situations where tissue pull-through is a risk. The technology, called Force Fiber Fusion, is a two-in-one construct that goes from a round suture to a flat braid center segment and back to round suture. It is made

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

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

Solar Atmospheres of Western PA expands with in-house tensile tests

Solar Atmospheres of Western PA recently announced that it has added another type of mechanical testing to its in-house repertoire: tensile testing. Tensile tests are essential in determining and understanding the ultimate strengths of materials. Solar Atmospheres has traditionally outsourced all tensile testing through locally accredited independent laboratories, but shipping and transportation of test specimens could

Qosina promotes Scott Herskovitz to CEO spot

Qosina (Ronkonkoma, N.Y.) has promoted Scott Herskovitz to president and CEO of the company – a global supplier of single-use components to the medical and pharmaceutical industries. Herskovitz was previously VP of sales and marketing at the company. Scott Herskovitz takes over Qosina from his dad Stuart Herskovitz, who remains board chairman. “I am very excited about

Abbott nabs CMS reimbursement for FreeStyle Libre continuous glucose monitor

Abbott (NYSE:ABT) said today that its FreeStyle Libre continuous glucose monitor is now available to Medicare patients, after the Centers for Medicare & Medicaid Services determined that the device can be classified as a therapeutic CGM. The FreeStyle Libre is designed to read glucose levels through a sensor worn on the back of a person’s upper […]

Zimmer Biomet wins FDA nod for Sidus stem-free shoulder system

Zimmer Biomet (NYSE:ZBH) said today it won FDA clearance for its Sidus stem-free shoulder system. The newly cleared Sidus system is designed as a total shoulder arthroplasty solution for patients with good bone stock with either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or those who’ve had previous surgeries of the shoulder that […]

Report slams European Union’s high-risk medical device approvals rate

A health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the December 2017 issue of Value in Health by ISPOR. The authors looked at 1,376 health technology assessment (HTA) reports filed between 2010 and 2015.