Researchers at the National University of Singapore have developed a soft sensor and actuator to monitor bladder volume and help empty it on-demand. The device is intended to be implanted on the bladder surface during a surgical procedure to treat patients who cannot completely empty their bladders voluntarily. Patients can suffer from an underactive bladder […]

ZOLL Medical, a part of the Asahi Kasei Group, won EU clearance for its SuperSaturated Oxygen (SSO2) Therapy System to be used to minimize the damage that heart attacks cause within heart muscle. Approved about a year ago in the United States, SSO2 is the only option beyond percutaneous coronary intervention (stenting) that can help […]

The current pandemic is revealing the level of commitment needed from multiple sectors to deliver innovative solutions to tackle severe shortages of personal protective equipment, ventilators, and raw materials. Researchers at the Prakash lab at Stanford University are no stranger to taking up extreme challenges, and they have kept up their reputation by coming up […]

As the COVID-19 pandemic continues, many healthcare facilities around the world are inundated with critically ill patients, and resources such as equipment and staff are stretched thin. Shortages of critical equipment, such as ventilators, can mean the difference between life and death for patients, and the need to keep critically ill patients comfortable and alive […]

Researchers at Purdue University have developed a new technique to dramatically enhance the resolution achievable when imaging intracellular structures with super-resolution fluorescence microscopy. The technique uses the distortions created by a specimen to pinpoint the location of individual molecules, and thereby infer the location of intracellular structures. The technique could be particularly useful in studying […]

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, […]

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 […]

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 […]

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 […]

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

Medical device manufacturer, Boddingtons, has lately been resourcing fast-tooling and moulding projects in relation to emergency procurement for the Covid-19 crisis.

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).

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

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

Mack Molding and Southwestern Vermont Health Care (SVHC) have partnered to develop an innovative alternative for Personal Protective Equipment (PPE) for healthcare workers.

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

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

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.

Olympus highlights two important standards for medical tubing, and explores inspection solutions that can help you meet them.

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

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

Exhibitors and attendees can now register for the show which is taking place in Shanghai from 14th to 16th September 2020.

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.

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.

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.

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.

Manufacturer Atermit has begun producing face shields to protect users from Covid-19 using Expanded Polypropylene Particle (EPP) foam - Arpro.

New era for lymphoma, leukemia, possibly other cancers

FDA working with manufacturers to prevent shortages

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

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

Braeburn Pharmaceuticals' CAM2038 gets positive FDA review

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 […]

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 […]

  MYTH: YOUR GENES ARE PATENTED. FACTS:  IT IS NOT POSSIBLE TO PATENT YOUR GENES The term “gene patent” is a misnomer, because genes as they exist in the body cannot be patented. Because a naturally-occurring gene – even a newly-discovered one – cannot be patented, patents don’t provide ownership rights over our genes, and […]

 Earlier today, the United States Supreme Court issued its opinion in the appeal of Stanford University against Roche Diagnostics. This case is of significant interest to the Biotechnology Industry Organization (BIO), Association of American Universities (AAU), American Council on Education (ACE), Association of Public and Land-grant Universities (APLU), Association of University Technology Managers (AUTM), and […]

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 […]

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 […]

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.

BIO is hosting a Translation Research Forum at the BIO International Convention.  NIH Director Collins keynotes an event that will explore how private, public and academic sectors can leverage meaningful partnerships, highlight emerging best practices, explore risk-sharing at the clinical research stage, and explore ways to bridge the gap in funding and know-how necessary to take […]

NHS England has expanded access to targeted hormone therapies for advanced prostate cancer

The closing of the acquisition remains subject to other customary closing conditions

Today, Chairs of the House Committees that oversee the Department of Health and Human Services (HHS) voiced their strong opposition to a harmful Trump Administration rule that would roll back Affordable Care Act (ACA) nondiscrimination protections. In a letter, House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), House Ways and Means Committee Chairman Richard E. Neal (D-MA), House Education and Labor Committee Chairman Bobby Scott (D-VA), and House Oversight and Reform Committee Chairwoman Carolyn B. Maloney (D-NY) urged HHS Secretary Alex Azar not to finalize this troubling rule and to instead focus on responding to the COVID-19 pandemic. The rule would overturn core protections for marginalized communities including LGBTQ+ people, women, individuals with limited English proficiency, and individuals with disabilities, and eliminate many health care programs and activities from coverage of the Affordable Care Act’s nondiscrimination requirements. “At a time when the United States is grappling with the 2019 coronavirus (COVID-19) pandemic and access to health care services is so critical, we are disappointed that this Administration is once again taking steps to limit access to health care and embolden discrimination against some of the most vulnerable among us,” the Chairs wrote. “If finalized, this dangerous rule would open the door to discrimination against patients in express contradiction to the plain language and intent of the law, and would therefore be illegal. Undermining protections for marginalized individuals at any time is unacceptable, but it is particularly egregious to do so during the worst global pandemic in over a century.” Read the full letter to Secretary Azar HERE. ###

May 8, 2020 (WASHINGTON) – Today, several House committee and subcommittee chairs sent a letter to the Departments of Homeland Security (DHS) and Health & Human Services (HHS) regarding recent news reports alleging that the Trump Administration is considering implementing policies that could unnecessarily delay migrant children in HHS care from being reunified with their sponsors.  The chairs again urge the Administration to rescind a Memorandum of Agreement requiring information about sponsors for migrant children be shared by HHS with DHS.  A group of House chairs previously wrote the Administration on this issue last July.  Despite current law, Congressional directives, and the current COVID-19 epidemic, the Administration continues policies that will lengthen the time migrant children spend in HHS care, thus keeping these children in congregate settings and therefore at heightened risk for exposure to COVID-19.  There have been 68 confirmed cases of COVID-19 among children in HHS care. The letter, led by Rep. Bennie G. Thompson (D-MS), Chairman of the Homeland Security Committee, has also been signed by: Rep. Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Committee; Rep. Jerrold Nadler (D-NY), Chairman of the Judiciary Committee; Rep. Nita Lowey (D-NY), Chairwoman of the Appropriations Committee; Rep. Lucille Roybal-Allard (D-CA), Chairwoman of the Homeland Security Appropriations Subcommittee; Rep. Rosa DeLauro (D-CT), Chair of the Labor, Health and Human Services, and Education Appropriations Subcommittee; Rep. Kathleen Rice (D-NY), Chairwoman of the Homeland Security Committee Border Security, Facilitation, and Operations Subcommittee; Rep. Zoe Lofgren (D-CA), Chair of the Judiciary Committee Immigration and Citizenship Subcommittee; and Rep. Diana DeGette (D-CO), Chair of the Energy and Commerce Committee Oversight and Investigations Subcommittee. Link to letter Letter text: We write with deep concern over recent reporting alleging that Administration officials are considering implementing policies that could unnecessarily delay the reunification of unaccompanied minors in the care of the Department of Health and Human Services (HHS) with their sponsors.  These concerns are heightened by the current COVID-19 epidemic, which poses significant risks for all individuals held in congregate settings. We are particularly wary of expanded information sharing under the Memorandum of Agreement (MOA) between your Departments. As we wrote last summer, we continue to have strong concerns that the MOA, which has been used in the past to deport a child’s family and loved ones, will have a chilling effect on reunifications by forcing migrant families to choose between sponsoring children and risking arrest. The effect of that policy undermines the best interests of children in HHS care. This is particularly dangerous given the ongoing coronavirus pandemic, which has already resulted in 68 confirmed cases of COVID-19 among children in ORR care, including 38 children within just one facility in Illinois. HHS previously fingerprinted all adults in a sponsor’s household for a period of about six months in 2018. However, according to HHS Administration for Children and Families (ACF) Assistant Secretary Lynn Johnson, HHS found that the extra screening did not add to the protection or safety of the children.   In addition, the HHS Office of the Inspector General (OIG) found that the MOA resulted in children spending a significantly increased length of time in HHS care, reaching an average length of stay of 93 days in November 2018. The OIG found that the length of stay declined as HHS reduced fingerprinting requirements.  The Administration must not revisit a policy that has been found to be detrimental to the interests of the children in its care. We find it extremely troubling that both the Department of Homeland Security (DHS) and HHS are reportedly considering ignoring Congressional directives and reimplementing policies that are expected to delay the placement of children in HHS care with sponsors.  The law has been clear – the Administration is not to deter potential sponsors from coming forward by using information shared under the MOA for deportation purposes, except in very limited, specified circumstances.  Yet DHS’ Immigration and Customs Enforcement (ICE) violated the law and utilized the information collected from adults deemed ineligible for sponsorship for deportation purposes.  ICE’s continued use of data collected by HHS for the placement of children in safe homes also represents a violation of the law. In addition, Congress directed HHS in the Fiscal Year 2020 Further Consolidated Appropriations Act not to reverse operational directives from 2018 and 2019 that reduced the length of time children spent in HHS care. Congress also directed HHS to “continue to work on efforts to reduce time in care and to consider additional policy changes that can be made to release children to suitable sponsors as safely and expeditiously as possible.”  We urge you to prioritize the safety and wellbeing of children in your care and rescind the MOA. In the midst of the COVID-19 epidemic, this should also include taking all reasonable measures to release children in your care to sponsors as quickly as possible. Thank you in advance for your consideration of these requests. #  #  #

Remdesivir, the investigational Gilead Sciences antiviral drug, looks more likely than ever to become the first treatment authorized by the FDA to treat patients with COVID-19. National Institute of Allergy and Infectious Diseases (NIAID) head Anthony Fauci praised the drug after preliminary data released this week from a federally funded trial involving more than 1,000 […]

If you’re looking for a Lyme disease vaccine, you can choose from among several—for your dog. A vaccine for humans hasn’t been available for years and few companies have tried to fill that void. Valneva has advanced its Lyme vaccine candidate to mid-stage clinical testing, and the company now has the help of drug giant […]