Abbott Laboratories has secured FDA clearance for its latest optical coherence tomography (OCT) imaging platform powered by the company’s new Ultreon software. The artificial intelligence (AI)-powered imaging software allows doctors to view coronary blood flow and blockages more clearly, aiding in care management and treatment decisions.
The U.S. Department of Justice (DoJ) has settled with two divisions of Abbott Laboratories of Abbott Park, Ill., over violations of the False Claims Act (FCA) in connection with devices alleged to have been defective. While neither claim recites a specific allegation against corporate executives with St. Jude Medical and Alere, the more conspicuous aspect of these agreements is that they are both directed toward activities that ceased in 2016, making clear that federal attorneys have long memories where problematic devices are concerned.
Medtronic plc is ceasing global sales and distribution of its Heartware ventricular assist device (HVAD) due to safety concerns. The news sent Medtronic shares down about 1% in early morning trading. The Dublin-based company said it made the decision to stop selling the HVAD left ventricular assist device after clinical comparisons found a higher frequency of neurological adverse events, including stroke and mortality, with its heart pump device vs. other circulatory support systems.
COVID-19 continues to dramatically reconfigure medicine as an ever-broadening array of digital therapies rolls out and telemedicine tackles increasingly complex applications. Abbott Laboratories’ newly launched Neurosphere Virtual Clinic exploits both trends to make management of chronic pain and movement disorders easier for patients.
The U.S FDA’s response to the pandemic has been all-consuming, but epidemiologist Michael Mina of Harvard blasted the agency’s handling of rapid testing. Mina said the agency is in possession of emergency use authorization filings for rapid antigen tests that should be acceptable, but that the FDA is “the only bottleneck” in the rapid antigen testing pipeline.
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.
