The Canadian Government released a contact tracing app called COVID Alert. After downloading the app, the app notifies you if you have possibly been exposed to someone with Covid-19. This is beneficial as symptoms of Covid-19 can appear days later or in some cases with symptoms not appearing at all. Many Canadians are wary about the app, believing it is too invasive. However, this should not be a concern as the app does not know your location, name, address, or your health information. The app uses Bluetooth to exchange codes with phones nearby and checks everyday if any of the codes It has received have identified as Covid-19 positive within a 14-day range. If it has, you will be notified. It should be noted that this app is not intended to replace manual contact tracing, nor does it replace medical advice. If you are feeling unwell you should still see a doctor or healthcare provider, and local public health authorities will conduct manual contact tracing if you are diagnosed with Covid-19.  

Apple Inc. Collaborated with the White House Coronavirus Task Force and the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention (CDC), to create an app which guides its users through a Covid-19 screening questionnaire. The result of the questionnaire indicates if you should seek medical care for your symptoms.  The app also provides recommendations for social distancing, self-isolating, how to monitor symptoms, and when it is recommended, to contact a medical provider. Apps such as these are especially important in situations where screenings, tests, or medical care can be costly or unaffordable for families.  

The common theme between the two apps is that they are only good if people use them. It is important for your own safety and the safety of your community to monitor your symptoms and conduct Covid-19 safe practices, and these apps are there to help.  

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA. 

The post You and your Smart Phone Against Covid-19 appeared first on Focal Point.

The decline in the biomedical technology industry was seen in the last weeks of March due to an overall decline in sales, procedures, and testing. As well, many hospitals restricted their surgeries to only necessary surgeries to preserve resources and staff. This resulted in great losses for hospitals and suppliers. However, the losses for hospitals continued through the cost of increasing PPE, reconfiguring spaces, new medical equipment, and the need for increased labor. Although some hospitals have started to allow elective surgeries to begin, such as hospitals in China, the surgery rate has not returned to its normal amount. It has been theorized that this is from consumer hesitation and concern of safety. Therefore, although the decline is lessening, it may still be a while until the biomedical technology industry and hospitals return to normal. 

With that being said, certain biomedical technology companies have actually experienced a dramatic increase in sales in certain departments. Companies that were already producing products that could aid in the coronavirus pandemic, such as assistive breathing and intensive care devices, have experienced an increase in profit caused by the high demand.  For example, Hillrom, a producer of non-invasive ventilators, patient monitoring devices, and smart beds, experienced an extreme increase in sales. In fact, the company increased ventilator production by fivefold and are hiring temporary and permanent employees. 

Other biomedical technology companies have experienced a market gain through the creation of precautionary medical equipment, such as Hologic. Hologic developed a SARS CoV-2 diagnostic test that is compatible with many hospital’s systems. The test produces results within three hours. Since the release of the test, the company has experienced their highest groth rate in eight years and has increased their production of the tests by 12-fold. 

People have recognized this ability to succeed in the biomedical technology industry during this time, but some people have been dishonest when trying to find success. As such, the US FDA has seen an increase in fraudulent products. An explanation of the US FDA’s guidance for innovators and researchers can be found  here. Therefore, although the biomedical technology field can help greatly during this difficult time, it is important to remember the regulatory steps required in the process. 

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

The post COVID-19 Impacts on Biomedical Technology Industry appeared first on Focal Point.

So, how does it work? The laser ultrasound machine consists of two lasers; one that emits a light wave and one which receives a soundwave. The conversion from light to sound waves occurs on the skin. The light wave causes the blood vessels in the skin to expand. The body then cools the blood vessels causing them to shrink. This rapidly repeats as continuous light wave approach. The repetition of this process results in vibrations along the skin. These vibrations make up a soundwave. The conversion from light to soundwave was critical for this cutting-edge medical device as soundwaves travel deeper into the body allowing for a more in-depth image of the desired area.

After the conversion, the soundwave travels into the body and is reflected at varying frequencies as skin, muscle, and bone tissue absorb different amounts of the produced soundwave. The reflected soundwave is then absorbed by the second laser. Finally, the information received by the second laser is translated into an image. This medical device is profound by converting the light wave to a soundwave in order to remain independent from the body.

Although ultrasound is already considered a non-invasive procedure, the ability to conduct one without any contact at all is beneficial to patients who cannot be touched. Such patients could be infants, burn victims, and patients trapped in an accident. The researchers at MIT hope to improve the depth and accuracy of this new medical device. The researchers also hope to decrease the size of the technology with the aspiration of making the laser ultrasound a household medical device for preventative and proactive medical care. With technology like this already being discovered this early in 2020, it is clear that the future is bright, inventive, and upon us now!

To see an explanation of the laser ultrasound directly from MIT, please click here. For another article on this topic, please click here.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA

Emily Campbell

The post The Future is Now: A Zero Contact Ultrasound appeared first on Focal Point.

However, both small beauty brands and multinational cosmetic corporations are rethinking their packaging models to consider more eco-friendly options in order to reduce their environmental footprints. A post published by Cosmetics Design USA states that Veolia, a world leader in waste management, is teaming up with Unilever to take a leadership stance in defining responsible packaging initiatives for future generations. Recyclables are only recycled if they are deemed as useful materials for future use. Thus, Unilever not only aims to use plastic packaging that is made of fully recyclable materials, but to incorporate 25% of recycled material into its packaging by 2025. Unilever and Veolia plan to start their collaboration by collecting materials from India and Indonesia.

The Terracycle Zero Waste Box

Although the spotlight is on eco-friendly cosmetic packaging, these changes can’t happen overnight. According to Cosmetics Design USA, TerraCycle has taken a different approach towards diverting from filling landfills with post-consumer waste. RecycleSmart has teamed up with Terracycle to introduce waste collection boxes, called the Terracycle Zero Waste Box, designed to recycle anything.

How does it work? A customer will first select a waste stream that they would like to recycle. The waste streams span a large variety of household items such as jewellery, luggage bags, garden products, and health care packaging. Once the waste stream is chosen online, the boxes can be ordered and delivered to the customer’s house to be filled up. Once the boxes are full, the customer ships them back to Terracycle, where the product constituents are sorted into metals, plastics, organics, fibers, fabrics, glass, e-waste, cigarette waste, and latex paints. Once sorted, the products are repurposed into creative products instead of being sent to landfill.

It is evident that many companies are developing various approaches to tackle the environmental issues that threaten society, and consumers these days are expecting no less.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

The post Recyclable Cosmetic Packaging – A Step Closer to an Eco-Friendly World appeared first on Focal Point.

A Health Canada project worked to reduce this burden by decreasing the regulatory requirements for sunscreen products being imported from the U.S. After the one-year pilot project, which ran from February 27^th, 2017 to February 27^th, 2018, Health Canada is now looking to expand the pilot to include additional jurisdictions, including Mexico, Japan, Australia, Switzerland, the European Community (EC), and the European Economic Area – European Free Trade Association (EEA – EFTA). This project, to expand the Sunscreen Pilot to include other countries with existing Mutual Recognition Agreements (MRAs) will significantly reduce, or eliminate completely, the need for additional confirmatory testing that is done when importing sunscreen products into Canada.

The details of the expansion are outlined in Drug Establishment Licensing (DEL) Bulletin #41, which was issued by Health Canada in November 2018, and will come into effect February 14^th, 2019. The Expanded Pilot replaces the 5-year limit on absence of US Food and Drug Administration or Heath Canada inspections with mandating that GMP renewal evidence be submitted on or before a New Evidence Required By (NERBY) date. It also includes sunscreen products which have been fabricated in Canada, but packaged, tested, or labelled in any of the original or newly included jurisdictions. Currently, the project’s focus is on sunscreens, however other low-risk products such as anti-dandruff shampoo and mouthwash may be introduced in the future.

The application process for participating in the Expanded Sunscreen Pilot includes submitting a complete application package, which can be found on the Health Canada website.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

The post Expanded Sunscreen Pilot – Health Canada appeared first on Focal Point.

Omron Healthcare Inc. has recently disclosed a new feature that allows Amazon Alexa devices to take blood pressure readings, as well as compare them to other readings taken over time. Amazon Alexa users can ask simple questions about their blood pressure, and receive information about their cardiovascular health from the comfort of their own home.

How can it be used?

The new technology can be accessed through the Omron Connect app used in conjunction with the Alexa app, both of which can be downloaded for free from Apple iOS or the Google Play store. They can sync with Omron’s blood pressure monitors, and provide information on average readings, or judge the readings against the last highest/lowest recorded readings, and much more. It also allows Alexa to provide guidelines for measurement to ensure the readings are taken accurately, making the monitoring of blood pressure easy for patients new to the practice.

For those without adverse health conditions, regularly monitoring blood-pressure with Alexa can provide insight on cardiovascular health conditions for proactively taking health into one’s own hands. It can help one act sooner on obscure numbers and can potentially be life-saving.

Omron Healthcare European president and CEO André Van Gils said: “It’s more important than ever for us to find new ways to help people simplify and ease their blood pressure monitoring habits, so that they can understand and manage their condition more efficiently.”

This new cardiovascular health monitoring addition to Amazon Alexa has consumers wondering what Amazon will come up with next.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

The post Alexa – Your New Best Friend for Cardiovascular Health? appeared first on Focal Point.