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A Multinational Effort to Reduce Neonatal Mortality: Interview with Dr. Maria Oden, Co-director of Rice 360° Institute for Global Health

According to the World Health Organization, 47% of childhood deaths worldwide occur in the first four weeks of life. This neonatal mortality rate is particularly prevalent in sub-Saharan Africa, where nearly one million newborns die every year. Many of these deaths can be prevented with medical devices that more developed countries often take for granted, […]




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Cleanbox Uses UVC to Decontaminate 100 Surgical Masks Per Hour

In the era of COVID-19, surgical masks are a necessity for all healthcare workers and an effective way to curtail the spread of the virus within the general public. Since surgical masks are still in relatively short supply, companies and researchers have been working on ways to make available masks last longer. Cleanbox Technology, based […]




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LifeSignals Receives CE Mark for ECG Remote Monitoring Patch

LifeSignals, based in Fremont, California, announced that it received the CE Mark for its LifeSignals ECG Remote Monitoring Patch. The patch, integrated with a remote monitoring platform, is designed as a continuous electrocardiography (ECG) and heart rate monitor. The ECG Remote Monitoring Patch is disposable and captures data for up to three days. The device […]




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VitalPatch Wins FDA Emergency Use Authorization for Cardiac Monitoring in COVID Patients

VitalConnect announced that it has received FDA Emergency Use Authorization status for use of its VitalPatch to detect changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19. Hydroxychloroquine and chloroquine, used to treat some COVID-19 patients, are associated with risk of prolonged QT interval that can lead to life-threatening arrhythmias. VitalPatch allows […]




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Intertronics launches device capable of mixing two-part materials

Adhesives specialist Intertronics has launched the preeflow eco-DUOMIX, a system that mixes and dispenses two-part materials.




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EU MDR is likely to be postponed due to Covid-19, but what about IVDR?

MedTech Europe has issued a statement welcoming the delay for enforcing the European Medical Devices Regulation (EU MDR), and asking for similar action for the In Vitro Diagnostic Regulation (IVDR).




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How Compounding Solutions are meeting the demand for medical materials during Covid-19

Since early February, custom material solutions provider, Compounding Solutions, has been working hard to meet material demands related to Covid-19.




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Elastomers 2020 US Summits to be delivered in a virtual format

In light of Covid-19, Smithers Thermoplastic and Silicone Elastomers US Summits will now take place in a virtual format.




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Teknor Apex develops new series of TPEs

Advanced chemistry developed by Teknor Apex has yielded a new series of ThermoPlastic Elastomers (TPEs) for over-moulding that exhibit adhesion to engineering plastic substrates while meeting the requirements for use in medical devices.




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The force: How to improve ultrasonic plastic welding

Tom Hoover, senior medical business development manager – Americas, assembly technologies, at global technology and manufacturing company, Emerson, explains how ultrasonic plastic welding is improved through improved force control.




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Q and A: How Protolabs and Essentium are helping fight Covid-19

MPN editor Laura Hughes reached out to Blake Teipel (BT), CEO and co-founder of Essentium, and Gurvinder Singh (GS), global product director, injection moulding at Protolabs, to find out how the companies were helping with the pandemic.




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How to ensure high quality plastics are delivered on time

During Covid-19, magnetic separation, metal detection, and conveying products are essential because they support the plastics processing industry and protect plastic from metal contamination.




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Choosing a fitting for your medical device: What to consider

Ashley Philipp, marketing director, Injectech, explains the importance of considering barb styles when choosing a fitting for your medical device.




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Ventilators from Dyson are 'no longer required' in UK

The Dyson CoVent ventilators are no longer required in the UK, according to a statement from Sir James Dyson.




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Packaging company ships over three million face shields to help with pandemic

Thermoformed packaging company Lacerta has managed to ship over three million Personal Protective Equipment (PPE) face shields to healthcare and frontline workers, in response to the coronavirus pandemic.




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How a custom plastic injection moulder is coping with the rise in demand due to Covid-19

Diversified Plastics (DPI), a custom plastic injection moulder and additive manufacturer of high-precision components, has increased the capacity of its Acceleration Station to meet the rise in demand associated with the Covid-19 pandemic.




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‘Instant’ validated labelling platform available for ventilator manufacturers

Prisym ID, a provider of data-led label and artwork management solutions, is offering instant access to its Prisym 360 SaaS medical devices labelling solution, to support medtech manufacturers’ response to Covid-19.




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Greenlight Guru announces partnership to simplify global market access for medical device companies

Greenlight Guru, a Medical Device Quality Management Software (MDQMS) platform, has teamed up with Emergo by UL, a consulting firm specialising in global medical device regulatory compliance.




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Q&A: How SweynTooth medical device hackers can be thwarted

Ian Bolland spoke to Chris Risley, CEO at Bastille Networks, about medical devices at risk of being compromised by SweynTooth vulnerabilities, highlighting how hackers can be combatted from targeting devices and healthcare systems.




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Survey suggests manufacturers need more support from the government

Small to medium-sized (SME) manufacturers are calling for greater and faster financial support from the government as they confront plummeting sales, production volumes, and the prospect of job cuts amid the ongoing Covid-19 pandemic.




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Support terminated for four devices in the Ventilator Challenge

The UK government has announced it will be ending support for four devices in the Ventilator Challenge.




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How Covid-19 is impacting the medtech industry

Munich-based software start-up Climedo Health has published a whitepaper assessing the "Impact of Covid-19 on the medtech industry".




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AdvaMed asks for additional tariff relief to tackle Covid-19

The Advanced Medical Association (AdvaMed) has requested the United States Trade Representative (USTR) provides additional tariff exclusions for medical devices, components and supplies coming from China which are necessary to help with Covid-19.




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Sumitomo (SHI) Demag announces joint venture to strengthen market presence

The new company called PlastiKCs, was founded by injection moulding expert Kurt Callewaert, together with Thiele & Kor Plastics Machinery, a long-standing representative of Sumitomo (SHI) Demag.




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Medtech company announces Covid-19 services for ‘at risk’ patients

HealthBeacon, a medication adherence technology company, has launched a new Covid-19 support offering for patients on injectable therapies.




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Adhesives specialist launches campaign to improve productivity

Adhesives specialist Intertronics has launched a new campaign to highlight the ways that assembly companies can simplify processes, improve output and reduce waste.




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How a chemicals company is helping with the Covid-19 pandemic

Chemicals company Lubrizol is helping with the pandemic by making materials used in Personal Protection Equipment (PPE) as well as hand sanitiser and products to help treat patients who are fighting the virus.




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Roche receives approval for Covid-19 antibody test

Roche’s antibody test for Covid-19 has been given the CE mark and has been issued Emergency Use Authorisation from the US Food and Drug Administration.




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Formlabs receives FDA go-ahead to print BiPAP adapters

3D printing company Formlab​s has received emergency use authorisation (EUA) from the U.S. Food and Drug Administration (FDA) to print bi-level positive airway pressure (BiPAP) adapters designed by Northwell Health, a New York healthcare provider.




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University of Glasgow issues plea for acetate sheets to help produce plastic visors

Engineers from the University of Glasgow are responding to the coronavirus pandemic by producing up to 1,000 pieces of Personal Protective Equipment (PPE) each day.




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The impact of Covid-19 on the European medical device market

Dr Archana Nagarajan, a freelance scientist specialising in medical devices at Kolabtree, the online freelance platform for scientists, explains the changes made to the European medical device market in light of the pandemic.




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Scientists are developing an anti-coronavirus surface coating based on nanomaterials

The research by Ben-Gurion University (BGU) and the National Institute of Biotechnology in the Negev (NIBN), has received financial support from the Israel Innovation Authority as part of a call for proposals for coping with the coronavirus.




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Med-Tech Innovation Expo rescheduled for June 2021

Rapid News Group has announced the decision to postpone Med-Tech Innovation Expo, the UK’s flagship event for the medical device industry to 2021.




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Why 3D printing has proven to be the ‘true hero’ during this pandemic

John Dogru, CEO of 3DPrinterOS, spoke to MPN’s editor Laura Hughes about the pivotal role of 3D printing during the Covid-19 pandemic.




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AdvaMed launches platform to help scale the production and distribution of ventilators

AdvaMed has announced the launch of a new platform, which will attempt to connect ventilator companies with component suppliers to ensure quick scale production and distribution of these devices during the Covid-19 pandemic.




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Manufacturer vows to work ‘round-the-clock' to provide healthcare workers with PPE

To help with the increased demand for Personal Protective Equipment (PPE), Suffolk based manufacturer Broadwater Mouldings have turned over its 3D printer to produce protective shield frames for healthcare workers.




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Thumbs Up to Latest CAR T-Cell Approval

New era for lymphoma, leukemia, possibly other cancers




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Device Supplies from Puerto Rico Under Threat (FDA</em>)

FDA working with manufacturers to prevent shortages




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Morning Break: Is the IRS an Obamacare Savior? No Mugabe at WHO; Price on HIV Quarantine

Health news and commentary from around the Web gathered by the ALLMedPage Today staff




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Towards Faster Device Approvals (FDA</em>)

Agency moves toward more accelerated reviews




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Expert Panel to Review Long-Acting Buprenorphine Injections (FDA</em>)

First up: monthly depot formulation from Indivior




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Friday Feedback: Research on Lipid-Lowering Therapies 'Alive and Well'

Experts discuss recent cancellation of first-in-class drug




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Low-Dose Rivaroxaban Green-Lighted by FDA

For continued prevention of recurrent VTE




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FDA to Review Second Long-Acting Opioid Treatment (FDA</em>)

Braeburn Pharmaceuticals' CAM2038 gets positive FDA review




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Huffington Post: Data Exclusivity: Getting the Balance Right

Huffington Post: Data Exclusivity: Getting the Balance Right      A great article on the downsides of cutting or removing data exclusivity provisions for biologics.  The article points out that data protection is needed to enhance safety and create incentives to research and produce new innovative drugs that cost billions of dollars.  However, the author argues that the period must be […]




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BIO’s “What Every State Should Know About Bayh-Dole” Webinar

BIO’s “What Every State Should Know About Bayh-Dole” Webinar The Biotechnology Industry Organization (BIO) recently hosted a webinar entitled: “What Every State Should Know About Bayh-Dole: Leveraging University Research to Create Jobs and Spur Economic Development Benefits.” The Bayh-Dole Act, enacted in 1980, placed patent ownership of federally funded research at universities in the hands […]




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Debunking the Myth: ‘Gene Patents’ are not necessary for healthcare innovation.

Myth: ‘Gene Patents’ are not necessary for health care innovation. Facts: Patents on DNA preparations or sequences are often the first patents upon which a later technology platform or portfolio is built.  These patents are often in-licensed from universities by small start-up companies for the purpose of additional R&D, evidencing that the public/non-profit university sector cannot bear […]




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Supreme Court Affirms: High Level of Proof Needed to Invalidate A Patent

Posted by Stephanie Fischer on June 10, 2011 at 3:29pm EDT on BIOtech Now The U.S. Supreme Court issued a favorable decision yesterday in the critical case of Microsoft v. i4i, in which Microsoft challenged the “clear and convincing evidence” standard traditionally used by courts in determining whether to invalidate an issued U.S. patent.   Microsoft argued for a lower “preponderance […]




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BIO has issued a strong letter of support for the Manager’s Amendment to H.R. 1249, the America Invents Act

by Stephanie D. Fischer BIO has issued a strong letter of support for the Manager’s Amendment to H.R. 1249, the America Invents Act.  The letter is posted on our website and the text is below: “On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for your Manager’s Amendment […]




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University-Industry Partnering at BIO Convention Webinar by AUTM June 16, 3-4PM

Get the inside information on what industry does and does NOT want from their academic counterparts: Join us June 16, 3-4 p.m. EDT for Insider’s Guide to Effective Partnering at BIO 2011, a FREE AUTM webinar to help you prepare for the BIO convention in Washington, DC, June 27-30.