FDA Authorizes First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - FDA. gov

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According to the news release:

"Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” "

Read the full news release:

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - Test is authorized for individuals two years of age or older, including those not showing symptoms - FDA.gov

What to Know About At-Home Oxygen Therapy - FDA . gov

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Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy

Giving yourself too much or too little oxygen can be dangerous. Talk with your doctor & get a prescription before buying an oxygen concentrator for use at home.

Read the full source article:  Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy - FDA.gov

According to the article:

"One way to get extra oxygen into the body is by using an oxygen concentrator. Oxygen concentrators are medical devices required to be sold and used only with a prescription.

You should not to use an oxygen concentrator at home unless it has been prescribed by a health care provider. Giving yourself oxygen without talking to a doctor first may do more harm than good. You may end up taking too much or too little oxygen. Deciding to use an oxygen concentrator without a prescription can lead to serious health problems such as oxygen toxicity caused by receiving too much oxygen. It can also lead to a delay in receiving treatment for serious conditions like COVID-19.

Even though oxygen makes up about 21 percent of the air around us, breathing high concentrations of oxygen may damage your lungs. On the other hand, not getting enough oxygen into the blood, a condition called hypoxia, could damage the heart, brain, and other organs.

Find out if you really need oxygen therapy by checking with your health care provider. If you do, your health care provider can determine how much oxygen you should take and for how long."

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New Joint Commission Video Offers Advice on Medical Care at Home

New Joint Commission Video Offers Advice on Medical Care at Home:

"Video characters Nurse Clare, Home Care Aide Jesse and Home Medical Equipment Specialist Boyd help Hector in his home with his IV, oxygen tank and daily living needs while his wife Reyna watches and helps. "Speak Up: At Home" emphasizes that patients and their families or friends should ask questions in order to be sure they receive the care necessary to get better."

Follow this link to the video, Speak Up: At Home

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Top Trends For The Medical Equipment Market

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Updated February 27, 2026

The link in the original post below didn't age well.

You might also be interested in:

GVR Report coverU.S. Durable Medical Equipment Market Size, Share & Trends Report

U.S. Durable Medical Equipment Market (2026 - 2033): 

https://www.grandviewresearch.com/industry-analysis/us-durable-medical-equipment-dme-market

- - original post follows below  - -

Another year year has gone by, and it was a tough one at that. Wishing you the best this coming 2009. As a preview of what's to come, read this excellent analysis by the folks at Reports-Research.com, "Top 10 Medical Equipment Market Trends For 2009." If you don't have time to read this detailed post, here are the high points . . .

1. Obama Plans To Bring Stellar Growth For Healthcare Information Technology
2. Home Healthcare Equipment Market Is Poised For A Big Return In 2009 Owing To Cost Containment Efforts By Both Providers And Purchasers
3. Emerging Medical Equipment Markets Will Continue To Grow In 2009, Assisted By The Ongoing Trend Towards Medical Tourism And Helping To Offset Any Negative Impact Felt By The General Economic Downturn
4. Major Medical Equipment Manufacturers To Remain Stable In Spite Of Mounting Financial Crisis
5. Direct To Consumer Advertising Of Medical Devices To Continue To Increase In Prominence In 2009
6. Healthcare Information Technology Spend To Gain Significant Attention In 2009 And Beyond From Both Developed And Emerging Economies
7. Drug Eluting Stents On A Comeback Trail In The US Market
8. In 2009Young Adults And Middle Aged Patients To Drive The US Market For Hip Resurfacing For Next Five Years
9. Cash Rich And Innovative Companies To Benefit In The Current Economic Scenario
10. Products Related To Women’s Health, Minimally Invasive Surgery And Home Healthcare Are Set To Garner Special Attention In 2009
11. High Volume And Low Value Of Deals Will Be A Norm In The Medical Equipment Mergers And Acquisitions Landscape In 2009

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SpermCheck Vasectomy - A Home Test - Medical Device

This recent Journal of Urology abstract, "Clinical and Consumer Trial Performance of a Sensitive Immunodiagnostic Home Test That Qualitatively Detects Low Concentrations of Sperm Following Vasectomy, concludes that SpermCheck Vasectomy, a simple and reliable immunodiagnostic test, can provide evidence of vasectomy success or failure, and offers a useful alternative to improve compliance with post-vasectomy sperm monitoring. It is currently the only FDA-approved test for this purpose. Monitoring is important because vasectomies are not 100 percent successful, and men who have had them can experience recanalization, or spontaneous healing, leading to restored fertility. Traditionally, after a vasectomy has been performed, the monitoring process involves bringing semen samples to a doctor's office or laboratory at two- and three-month intervals after the procedure. This at-home test is designed to help couples monitor and confirm that post-vasectomy sperm concentrations have reached infertile levels and avoid any surprises. The device is undergoing commercialization through a start-up company. 

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Home Medical Testing Kits - Overview and Recommendations (video)

 I really like this MSNBC video, "Medical Testing At Home." It provides an introduction to home testing and includes some important tips, such as:

• Read the label and instructions carefully
• Use only FDA-approved tests
• Follow all instructions
• Keep good testing records
• Call the 800 number for questions

I was surprised by the breadth of tests available, for example, blood pressure, blood sugar, drugs of abuse, cholesterol, fertility, etc. In some cases, brand recommendations are made.

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Wow! This New Home TeleHealth Device Brings The Future Closer

The future keeps getting closer. I never knew Intel had a hand in the home health care management arena for folks with chronic medical conditions. The FDA just approved their Intel Personal Health System. This is really exciting for me to read because over the last couple of decades, health care systems have attempted to connect to patients in their home via telemedicine or video devices with various degrees of success. What's going to be really important is how these kind of devices will get integrated with what will become the power players in the personal health record space. What I mean is, offerings like Google Health, and Microsoft HealthVault.

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