Fierce Medical Devices

Battelle received an emergency go-ahead from the FDA over the weekend to deploy its decontamination system for personal protective equipment, allowing healthcare workers to clean and reuse scarce N95 respirator masks.

The limited supply of ventilators is one of the chief concerns facing hospitals as they prepare for more COVID-19 cases. In Italy, where hospitals have been overwhelmed with patients in respiratory failure, doctors have had to make difficult life-or-death decisions about who gets a ventilator and who does not.

In one of the longest studies to date in high-risk heart disease, researchers found no significant difference in death rates over more than 10 years—as well as in cases of heart attack or stroke—between people that had received a drug-eluting stent for their blocked coronary artery compared with those who underwent standard bypass surgery.

Medtronic is back with new data finally demonstrating the effectiveness of its catheter-based ablation procedure aimed at the kidneys to help lower high blood pressure where multiple medications have failed.

In 2019, Edwards Lifesciences presented data showing that patients undergoing less-invasive, transcatheter aortic valve replacement procedures performed better after one year compared to those who had had open heart surgery. That study continues, and now—at the two-year mark—the data indicates that both sets of patients fare equally well when it comes to risks of stroke, hospitalization and death.

Abbott is launching a rapid coronavirus test able to deliver positive results in as little as five minutes, from a table-top box the size of a small toaster oven.

Demand for critical medical supplies continues to rise, as does the number of COVID-19 cases, and 3D printers have been seen as a way to help bolster manufacturing capabilities, wherever it is needed. Now, the FDA will be working with government and public-private partners to distribute and evaluate 3D designs and models, in a bid to provide desperately needed hardware and parts.

The FDA issued a wide-ranging emergency policy allowing alternative devices to be used as potentially lifesaving ventilators as shortages begin to impact hospitals’ responses to the coronavirus pandemic.

Expanding the reach of its digital therapeutic programs from substance abuse disorders to insomnia, Pear Therapeutics has received a new FDA clearance for its neurobehavioral app aimed at chronic sleeplessness.

The FDA warned patients, parents and providers that various EpiPen models could malfunction and spring their needles early.

The FDA unlocked the use of convalescent plasma—derived from the donated blood of people that have recovered from COVID-19 and which may contain helpful antibodies—as an investigational treatment for patients with severe cases of the disease.

Ford Motor Company has outlined plans to re-task some of its manufacturing lines toward the production of much-needed medical equipment including protective face masks, personal air-filtering equipment and ventilator systems for intensive care units.

Mesa Biotech’s palm-sized Accula device is designed to enable near-patient testing, available anywhere outside of the laboratory, with results in about 30 minutes.

Since its coronavirus diagnostic received the first emergency green light from the FDA 10 days ago, Roche has delivered over 400,000 kits to laboratories across the U.S.—but CEO Severin Schwan said it could take weeks or even months for the industry as a whole to catch up to the widespread need for testing.

Eli Lilly detailed its plans to offer drive-through COVID-19 testing out of its Indianapolis headquarters—starting today for healthcare providers within the community.

The FDA is temporarily waiving its enforcement and inspection requirements to allow companies outside the healthcare industry—such as automakers and other manufacturers—to begin fabricating much-needed parts for ventilators and other respiratory hardware.

As the agency combats genuinely fake tests being shipped to the U.S. from overseas, telehealth companies just starting to offer home-based kits could be facing new hurdles.

The FDA has authorized its first rapid, point-of-care diagnostic for the novel coronavirus—allowing physicians in hospitals, clinics and emergency rooms to test a sample for the disease in about 45 minutes.

Shortly after telling researchers to go virtual to keep their clinical studies going, the FDA has issued a new policy giving manufacturers some leeway in marketing their remote vital-sign-measuring devices.

Using a regulatory pathway that allows patients with life-threatening conditions to use unapproved therapies, the FDA has granted “emergency expanded access” to Bellerophon Therapeutics’ inhaled nitric oxide delivery system for treating the novel coronavirus.