Editor's corner: The top 10 Fierce Medtech stories of 2021 tracked COVID testing evolution

As we start to close out our second year of the COVID-19 pandemic, it’s admittedly difficult to muster the feelings of hope and possibility that traditionally come with the season. After 2021’s vaccine gains and declining case numbers were rebuffed by delta—and now by omicron—we might not be exactly sure what comes next, but we’ve got a pretty good idea.

Even as the virus has continued to evolve, so has the shape of the industry’s response. So much has changed since the early months of 2020, with the intervening time giving us all new tools and a stronger footing against the coronavirus. Our most-read stories of 2021 reflect that fact.

Our top 10 of 2020 contained a largely unifying thread: How can medtech and diagnostic companies help us learn as much as possible about this emerging pandemic threat, and potentially contain it? 

The virus’ genetic code was beamed around the world in days. Screening tests followed soon after. And researchers made “spike protein” and “receptor binding domain” into household buzzwords. And as supplies of diagnostics, ventilators and protective equipment began to run dry, new options were designed and mass-produced for patients and providers facing the emergency. 

For 2020-plus-one, our biggest stories chart how those technologies evolved—through their ups and their downs—and in some cases, how they’ve settled in for the long haul. They include the debuts of some of the first COVID tests available at home and over-the-counter. 

The most-read stories also include setbacks, product recalls, FDA warnings and disheartening study results.

Our top story is from January and was about a study from the Centers for Disease Control and Prevention that examined Abbott’s paper card-based rapid antigen test—printed in the hundreds of millions and bought in bulk by the U.S. government—and found it may miss about two-thirds of asymptomatic cases. 

However, Abbott said its BinaxNOW diagnostic was much better at finding the people who may be infectious and carrying a higher viral load. It correctly identified more than three-quarters of that subset, and 92.6% of people displaying symptoms. More recently, Abbott said its rapid tests would continue to work against the omicron variant, as they do not rely on the virus’ mutated spike protein gene to deliver a positive result.

Second place went to coverage of the FDA’s first green light for an at-home COVID antibody blood test. While it can’t confirm an active infection, the prescription-only test aims to help healthcare professionals identify who may have developed an immune response.

The next three stories follow advancements in the field of diabetes tech and personal glucose monitoring. Know Labs unveiled its pocket-sized device that swaps fingersticks for radiofrequency sensors to help measure blood sugar molecules without breaking the skin.

After that was Senseonics’ report that its 180-day Eversense embedded glucose monitor would see its FDA review delayed by a tsunami of regulatory applications for COVID tests and other emergency products.

Then, a novel story about the discovery of a non-invasive glucose monitoring method: the Israeli medtech startup Hagar attributes its GWave sensor technology to the day the company’s co-founder serendipitously spilled his tea on a radiofrequency device, lighting it up with the sugar dissolved in his drink.

Our sixth article also makes an opportunity out of a setback, with ResMed moving to fill the void left by Philips’ global recall of its sleep apnea machines. The company launched a new connected ventilator model after it predicted the recall could drive an additional $300 million to $350 million in ResMed sales. However, a crimped international supply chain would hamper those efforts as well.

Meanwhile, CVS and Walgreens began rolling out over-the-counter COVID diagnostics this year, from Abbott, Ellume and other test makers. The two retail pharmacy chains began stocking virtual and in-store shelves in April with screeners that can be purchased without a prescription and used by anyone regardless of whether or not they are showing symptoms.

But another recall hit not long after, this time in the diagnostic space, with Quidel issuing new instructions for a year’s worth of PCR tests after discovering a risk of delivering false-negative results.

With so many different COVID tests on the market, the National Institutes of Health aimed to set the record a little straighter by comparing rapid antigen and PCR test results directly. Our ninth story showed how NIH found that they can be equally reliable when used as part of a regular screening regimen.

Finally, our last story on the top 10 most-read list tracked the FDA’s stark warning, urging the public to stop using rapid COVID tests produced by a company that had been tapped by the U.K. government to supply hundreds of millions of tests for its screening program. The agency told users to “destroy the tests by placing them in the trash” after a Class I recall notice from their manufacturer, Innova, which had distributed a limited number of kits in the U.S. before being granted an emergency authorization.

And while COVID-19 drove a lot of our coverage, many other conditions, research areas and patients deserve attention. This year’s class of the Fierce Medtech Fierce 15 is bringing new technologies to bear on maternal mortality, stroke, heart disease, surgery and orthopedics as well as novel advancements in genomic research and artificial intelligence (and, yes, COVID testing as well).

Nominations are currently open for the next Fierce 15, through mid-January, so please submit the companies you think are the fiercest in medtech. In the meantime, we will be taking a short publication break for the holidays. Please feel free to check in for any breaking news, and we’ll return to your inboxes Jan. 5.