Fierce Medical Devices

Though its first-quarter sales were up—due in no small part to the closure of its $4.2 billion acquisition of BTG last year—Boston Scientific’s total net income shrank down to a slim margin compared to 2019’s lead-off quarter.

Weeks after launching their own COVID-19 molecular testing initiatives, lab giants Quest Diagnostics and LabCorp have begun offering antibody tests nationwide for the next phase of the coronavirus pandemic.

Thrive found its blood test more than doubled the number of cases detected by traditional diagnostics, from 25% to 52% when added to a routine workup—and also revealed several cancers that have no standard screening methods, like mammograms or colonoscopies.

Merck & Co. has begun working with the non-profit Institute for Systems Biology and a consortium of companies to investigate the molecular mechanisms behind the novel coronavirus, in a bid to identify new targets for medicines and vaccines.

Members of Congress have called on the FDA to re-evaluate its stance toward COVID-19 antibody tests. Since mid-March, the agency has allowed diagnostic developers to bring their products to market without any outside evaluation that the results they produce are accurate.

The FDA granted two emergency authorizations to blood-filtering devices designed to assist the distressed immune and respiratory systems of patients with severe cases of COVID-19.

At the virtual annual meeting of the American Association for Cancer Research, Grail presented a new sub-analysis on its test’s performance, and specifically on how it would fit into everyday clinical practice.

Researchers at Battelle and The Ohio State University have developed a brain-computer interface that not only allows a paralyzed person to move their hand, but also regain a sense of touch.

Veracyte has been granted an exclusive license to a genomic blood test developed at Yale University capable of predicting the progression of idiopathic pulmonary fibrosis.

As hospitals redirect resources toward COVID-19 and patients put off less-urgent medical procedures and trips to the doctor, Medtronic has seen serious impacts on its bottom line—including a 60% drop in weekly revenue from the U.S., where the medtech giant does most of its business.

The current state of antibody testing for COVID-19 is “a disaster,” said Roche CEO Severin Schwan, as a large number of potentially inaccurate tests enter the market fueled by sky-high demand.

In recent months, people across many different fields have tried to take what they know and pivot it toward the challenges posed by the COVID-19 outbreak: some that you may expect—such as diagnostics, healthcare and tech companies, of course—and some you may not.

The FDA has given the green light to its first at-home test for COVID-19, allowing people to collect nasal swab samples themselves and then ship them to a clinical laboratory to be analyzed for signs of the novel coronavirus.

Novartis is taking another stab at the digital therapeutics space by acquiring a small startup developing a video game treatment for lazy eye, also known as amblyopia.

The FDA has given its blessing to an oral fluid test for the novel coronavirus developed by Californian diagnostic startup Curative, allowing its use nationwide.

As the U.S. begins to turn to antibody testing to help navigate new phases of the COVID-19 pandemic, an interagency collaboration will aim to evaluate these diagnostic products and their accuracy.

Roche announced plans to launch its own COVID-19 antibody blood test early next month as a complement to its previous high-throughput test for active infections authorized by the FDA in March.

Sanofi has begun working with California startup Luminostics to build an at-home test for COVID-19 that would use a sample reader powered by a user’s personal smartphone.

After developing a high-throughput assay and a rapid point-of-care test, Abbott is now launching its third COVID-19 diagnostic, focused on detecting a person’s antibodies to the novel coronavirus.

The U.S. Department of Health and Human Services has signed new purchase orders with seven medtech manufacturers, totaling nearly $1.44 billion, to add about 137,000 ventilators to the national stockpile by the end of the year.