From Hepa Wash’s new collaboration to Stimwave’s FDA clearance, here are five medtech stories we missed this week but thought were still worth mentioning. 1. Hepa Wash collaborates with GALS program Hepa Wash announced in a Dec. 7 press release that it has collaborated with the German Accelerator Life Sciences (GALS) program to expand its
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Registrar Corp. Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury. An adverse event is when a device has a malfunction that could cause death or serious injury. Importers report this information to the manufacturer. The FDA has announced
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Today’s Federal Register includes a new FDA proposal that is meant to streamline voluntary malfunction summary reporting for medical device companies. The proposal – which is now under a comment period until Feb. 26, 2018 – would allow a medtech company to provide certain malfunction medical device reports (MDRs) in a summary format on a
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Nanobiotix (EMA:NANO) said today that the FDA has approved its IND application for a cancer trial combining its radiotherapy-activated nanoparticle tech with an anti-PD1 antibody. The Phase I/II trial is slated to evaluate the safety and efficacy of Nanobiotix’s NBTXR3 product administered with checkpoint inhibitors in three groups of patients with recurrent or metastatic head and neck […]
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Charlotte Morello, Novasyte Health This is never as simple as it sounds, and it may even sound obvious. That said, it is one of the critically important steps to ensuring a recall is executed accurately and timely. At the end of the day, bad data costs money. It costs to acquire, compile, store and (mis)manage/maintain. It
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Charlotte Morella, Novasyte Health Prior to launching a field team to address the product need, it is critically important to assess the effectiveness of the field strategy as it could result in a significant, potentially unnecessary, budgetary hit. 1. What is the goal? Start by understanding and having internal alignment on the target metrics and/or
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University of Pittsburgh research has recently shown that smartphone sensors coupled with a specifically-developed algorithm could detect worsening symptoms in chemotherapy patients. The sensors offer a way for cancer patients to be remotely monitored. The sensors and algorithm can detect objective changes in patient behavior to determine if symptoms are getting worse. Indications of worsening
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Part design, material selection, mold design and processing all play a role when it comes to injection molding cooling time. Jeremy Williams, RJG Here’s a value that probably sticks out in your mind if you’ve been to an RJG training event: 80%. That’s how much of the molding cycle is spent cooling the plastic part
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Beta Bionics has raised $2.4 million in a new round of equity and securities financing, according to an SEC filing posted this week. A total of 11 anonymous investors have participated in the round, though the company has not yet stated who has joined or how it plans to spend funds raised. Read the whole […]
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South Korea’s regulatory bodies have agreed to adopt a “fast-track” approval process for next-generation medical devices, according to a new report from the Korea Herald. The policies are being enacted to promote medical devices whose success is dependent upon entering the market ahead of their competitors, and would allow devices to be certified on a […]
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Charlotte Morello, Novasyte Health It is easy to fall into the rhythm of receiving multiple spreadsheets from various sources – be it sales, regulatory, marketing or quality – and by having them in one place, feeling like the recall is “under control.” In working with more than half of the largest med-tech companies globally, Novasyte
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Comsol recently announced that it has updated its Multiphysics and Comsol server products to its new version 5.3a. The new version gives simulation specialists new modeling tools and increased solver performance. The update also offers shape memory alloy (SMA) material models, a method for capacitively couple plasma (CCP) simulations and a hybrid boundary element-finite element
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Morgan Advanced Materials’s Technical Ceramics business announced that it is launching a charge dissipative (CD) coating for ceramic parts to support the development of compact medical equipment. Reduced size and improved resolution and imaging performance is in high demand for medical diagnostic imaging equipment like CT scanners and mobile X-ray machines. Morgan’s CD coating of
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There are eight major steps you need to know in order to successfully get a medical device to market, according to Jim Medsker, president of Keystone Solutions Group. The steps provide a “general overview of the important issues to think about as an early stage company,” Medsker explained in a recent whitepaper. The eight steps
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The FDA announced today that it has cleared the Dermapace System diabetic foot ulcer treatment device for market. Dermapace System is the first shockwave device to treat foot ulcers caused by diabetes, according to the device’s creator Sanuwave. “Diabetes is the leading cause of lower limb amputations,” Binita Ashar, director of the division of surgical
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From NanoVibronix’s new Indian regulatory and distribution agreement to Guided Therapeutics’s Turkish distribution deal, here are five medtech stories we missed this week but thought were still worth mentioning. 1. NanoVibronix inks deal with Indian regulatory and distribution consultant NanoVibronix announced in a Dec. 20 press release that it has signed Morulaa HealthTech as its regulatory
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A test that measures the RNA or protein molecules in human cells is also able to detect when your body is fighting a viral infection from respiratory symptoms, according to Yale researchers. The test involves a nasal swab and could be a faster and cheaper way to diagnose respiratory viral illnesses. “It’s a simpler test
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The ringing in of the new year also rang in the return of the medical device tax, a 2.3% levy on medtech sales that went back into effect after a two-year pause. The U.S. Congress closed out 2017 without taking action to delay or repeal the medtech tax, despite broad support from both sides of the […]
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Stewart Eisenhart, Emergo Group Medical device regulators at the Food and Drug Administration have updated guidance clarifying what Least Burdensome Provisions mean for US market registrants. 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 of MedicalDesignandOutsourcing.com
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The development of the product development plan is an evolutionary effort that continues through the life of the medical device project. Bill Betten, Betten Systems Solutions, and Tom Waddell, Waddell Group This is the second in a series of articles that will discuss the design of innovative products in the highly regulated medical environment. The
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