The Biden administration said it will use the U.S. Defense Production Act to grapple with the COVID-19 pandemic in a plan that includes a large increase in vaccine purchases. Also on tap is an increase in production of at-home test by six companies in addition to Ellume Ltd., of Perth, Australia, which will ship more than 8 million of their tests to the U.S. by the end of the year.

Abbott Laboratories reported 2020 fourth-quarter revenue up 29% year over year to $10.7 billion, outpacing the consensus estimate of $764 million. The positive growth was largely fueled by sales in diagnostics, which surged 111% to $4.35 billion, from $2.10 billion in the prior year period. Net earnings for the period totaled $2.16 billion, or $1.20 per share, up from $1.5 billion, or $.59 per share a year ago. Adjusted earnings per share (EPS) was $1.45, ahead of the Street target of $1.35.

The U.S. Centers for Medicare & Medicaid Services (CMS) issued a final version of a proposed rewrite of the national coverage determination (NCD) for mitral valve repair devices that includes a coverage with evidence development (CED) mandate. The final also retains the draft’s provisions for secondary mitral valve regurgitation, which analysts say will double or even triple the market for devices thus approved by the FDA.

Abbott Laboratories plans to launch its Neurosphere Mypath digital health app in the coming weeks, the latest addition to its Neurosphere Digital Care connected health management platform. The new app will enable chronic pain patients trying out Abbott neuromodulation therapies to track and report their pain relief.

As COVID-19 cases surge across the U.S., there is growing demand for greater access to testing to rein in the pandemic. On Wednesday, the U.S. FDA granted an emergency use authorization (EUA) to Abbott Laboratories for at-home use of the company’s Binaxnow COVID-19 Ag Card Home Test. Abbott has teamed up with Miami-based telehealth provider Emed to distribute and administer the tests, with an expected 30 million in the first quarter of 2021.

The drug-eluting balloon (DEB) has not displaced the drug-eluting stent (DES) for treatment of infarcts, but that may be changing with the results of the PICCOLETO II study.

TORONTO – The Fionet Rapid Response Group formed by Toronto’s Fio Corp. and Relay Medical Corp. has received COVID-19 lateral flow rapid diagnostic tests (RDTs) from the European division of Abbott Laboratories Inc., Switzerland’s Roche Diagnostics AG and North York, Ontario’s Proprietary Innovation Labs Inc. for operation with its mobile testing and tracking platform.

Abbott Laboratories has seen the launch of the IonicRF Generator, which delivers a nonsurgical, minimally invasive treatment for the management of pain in the nervous system. The generator is a radiofrequency (RF) ablation device that uses heat to target specific nerves and block pain signals from reaching the brain. The launch of Abbott's IonicRF Generator looks to help the estimated 50 million people in the U.S. currently living with chronic pain.

Abbott Laboratories saw improvement with its medical devices and diagnostics in the third quarter, which featured wins in the areas of COVID-19, diabetes, and structural heart. The company revealed its quarterly results on a Oct. 21 call, during which management said it was increasing its guidance for full-year adjusted earnings per share (EPS) to at least $3.55.