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Medical Device industry news

Management Recruiters of Gastonia North help keep medical device professionals tuned to the latest industry news by providing access to the latest in technologies and breakthroughs, as well as resources for both clients and candidates.

Preparing for MDR: Don’t Forget about Class I Reusable Devices

Class III medical devices are getting a lot of airtime in the discussion about the EU Medical Device Regulation (MDR) preparation, but we can’t forget about reusable devices. Under MDR, there’s a new subclass for Class I reusable devices (Class Ir), such as surgical instruments and endoscopes, putting such devices under a higher level of…

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Insight Feb: Success in the Interview

Recently we had an engineer interview for a position he was highly qualified for because of his unique skill-set.  We worked with the client to help them quickly get from the candidate what they needed to ensure the technical criteria and let them focus on the cultural needs.  We prepared the candidate on the process…

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Long-term stroke risk cut by carotid surgery or stenting

An international research team who compared the long-term effects of carotid artery surgery and stenting found the risk of stroke “remarkably low” even 10 years later, regardless of the type of procedure. Short-term stroke prevention was found to be better among surgery patients, but stenting technology has improved since these patients were implanted, said the study’s…

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FDA details spike in reports of breast implant-associated lymphomas

The FDA has seen a jump in the number of cases of a rare type of lymphoma linked to breast implants, which the agency says results from its efforts to educate stakeholders of the risks, as well as its work to encourage patients and providers to file reports. The cases are related to breast implant-associated anaplastic…

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Swedish patient receives ‘dexterous, sentient’ prosthetic hand

A Swedish woman with a hand amputation has become the first recipient of an osseo-neuromuscular implant to control a dexterous hand prosthesis, according to Chalmers University of Technology in Gothenburg, Sweden. Surgeons placed titanium implants in the two forearm bones (radius and ulna), and extended electrodes to nerves and muscle to extract signals to control a…

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An oral insulin delivery system inspired by tortoises

Despite nearly a century of research, researchers have so far failed to develop an oral form of insulin that would allow patients with diabetes to avoid multiple daily injections. Now researchers from the Massachusetts Institute of Technology, Brigham and Women’s Hospital and Novo Nordisk say they have come up with an insulin pill, and it’s inspired by…

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Could this device replace pacemaker batteries?

The heart’s motion is so powerful that it can recharge lifesaving cardiac devices, according to new research from Dartmouth College. Engineers at Dartmouth’s Thayer School of Engineering developed a dime-sized device to convert the heart’s kinetic energy into electricity to power a wide range of implantable devices, according to the Hanover, N.H.-based college. Pacemaker and defibrillator…

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First Friday Preview: February

How leveraging training programs can attract and retain star employees of all ages The While many employees may be comfortable in their current roles, it’s probably safe to say that most top talent want to continually advance in their career. Regardless of whether the goal is to be promoted within a company, or simply stay up-to-date on new…

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A New Way to Model the Heart Valve

University of Texas Engineers have developed a noninvasive way to simulate repairs to the heart’s mitral valve allowing surgeons to provide patient-specific treatments. The mitral valve repair space just got a little less complicated due to research from a team of engineers from The University of Texas at Austin. The group has developed a new…

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FDA sets novel device approval record for 2018, outlines new criteria for 510(k) clearances

Last year set a new record for FDA approvals of novel medical devices, continuing the upward trend seen over the past few years, according to the agency. In 2018, the FDA greenlit 106 new devices—including premarket approvals and panel-track supplements; de novo and breakthrough 510(k) clearances; and humanitarian device exemptions—beating out 2017’s 40-year record of…

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Healing heart tissue by coaxing small arteries to grow

Some patients with blockages in the heart’s major arteries can still lead normal lives, basically performing all their everyday activities with no major limitations posed by their disease. But how? Joseph Woo, a professor of cardiothoracic surgery at Stanford University, figured it may be because those people have tiny arteries that bypass blood clots to reach…

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FDA Moves Closer to Modernizing 510(k) Program

FDA took the next steps this week toward establishing the framework that is now being called the Safety and Performance Based Pathway. The agency also is seeking input from the industry on its plan to promote the use of more modern predicate devices in the 510(k) program. FDA issued final guidance this week establishing the…

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Protein-Eluting Implant May Curb Seizures and Improve Cognition

Approach reduced seizures by 93 percent in three months in rats. A protein-secreting device implanted into the hippocampus of epileptic rats reduces seizures by 93 percent in three months, finds preclinical research published in JNeurosci. These results support ongoing development of this technology and its potential translation into a new treatment for epilepsy. Motivated by an unmet…

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Can a Polymer Help Reduce Deaths from Sepsis?

Sepsis is one of the leading causes of death in hospitals, and incidences are on the rise, according to the National Institute of General Medical Sciences (NIGMS). Two independent cohort studies published in JAMA found that sepsis contributed to 1 in every 2 to 3 deaths.1 Harshu Musunuri wants to help prevent such deaths. Majoring in Chemical Engineering at Stanford,…

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Scientists Develop Self-Dissolvable Antibacterial Bandages

An international team of scientists from the National University of Science and Technology “MISIS”, the Central European Institute of Technology and several other universities have developed a biocompatible material with antibacterial properties. The material is planned to be used for bandaging of wound skin, for example, burns and cuts. Such bandages will have a prolonged effect, act locally and, most importantly, will not require changing. The material…

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Sugary Stent Eases Suturing of Blood Vessels

Reconstructive procedures and organ transplants demand nimble fingers that can restore blood flow by stitching together millimeter-scale arteries. It’s a tough ask and time-consuming task for even the most skilled surgeon. But a stent full of sugar may help the surgeries go down—in a 3D-printed way. Designed by Nebraska engineer Ali Tamayol and nationwide colleagues,…

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AdvaMed Approves Updated Code of Ethics

The Advanced Medical Technology Association (AdvaMed) announced that its Board of Directors has approved an update of its longstanding Code of Ethics on Interactions with Health Care Professionals (HCPs) in the U.S. “The updates reflect evolving legal standards, care delivery models and best practices over the last decade—since AdvaMed’s last Code update in 2008—and are designed…

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Osteoporosis breakthrough: Bone mass increased by 800 percent

A groundbreaking set of studies has found that blocking certain receptors in the brain leads to the growth of remarkably strong bones. Could a new osteoporosis treatment be on the horizon? Osteoporosis most commonly affects older women. Primarily a disease of old age, osteoporosis can cause bones to become gradually weaker. Over time, bones become so porous…

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M&A, IPOs and VC raises: Biotech and medtech executives look to their crystal balls for 2019

SAN FRANCISCO—What can you expect from M&A, IPOs and venture capital raises in 2019? We spoke to a plethora of biotech and medtech execs at the J.P. Morgan Healthcare Conference this week to find out. At the start of the conference, we saw two major multibillion-dollar deals from Bristol-Myers Squibb and Eli Lilly for Celgene…

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Poop research might get a more polite name

No matter how you slice it, it’s still poop Photo: Lewis Ronald/Wikimedia Commons A poop by any other name is still a poop, but scientists are proposing a new name to describe the science of stool: in fimo. If it sticks, we might need to get used to hearing the phrase more often. The proposal, recently published in…

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