The cost of providing COVID-19 vaccines and therapies for a possible fall surge in the U.S. is coming at the expense of testing and personal protection equipment. While other countries are planning for the expected surge by placing their orders for vaccines and therapies, “we are starting to lose our place in line,” White House Coronavirus Response Coordinator Ashish Jha said during a June 9 media briefing.
Even as new waves of COVID-19 cause less direct disruption in the delivery of health care, the ongoing pandemic leaves a dramatically altered landscape for medical devices in its wake. The RBC Global Healthcare Conference revealed trends that will continue to reshape the utilization of medical technology and delivery of health care, while industry leaders drilled down into the details in a focused panel discussion. All agreed: the pandemic catapulted telemedicine and remote monitoring ahead five or more years, a hybrid delivery system with greater fluctuations in volume will emerge, devices that facilitate the movement of care out of the hospital to home or outpatient settings will remain in high demand and patient-centered control of health care will continue to attract additional industries into health care markets.
Although the death toll in the U.S. is nearing 1 million lives lost, signs continue to suggest that an end is in sight for the COVID-19 pandemic, the most disruptive global health crisis in a century. Now, into its third year, those at-risk have numerous options and growing numbers of people have achieved immunity through vaccines and infection.
The U.S. Department of Justice and the Securities and Exchange Commission have separately indicted Marc Schessel and his company, Scworx Corp., for making false statements about the company’s ability to provide rapid tests for the COVID-19 pandemic. The indictments include allegations that Schessel and his company had been advised that the tests they had intended to procure were no longer available for distribution in the U.S., but that the Schessel did not advise shareholders of this fact for another 11 days.
Lumiradx Ltd. has secured CE marking for its HbA1c test for diabetes. The point-of-care (POC), automated fingerstick assay is run on the Lumiradx portable platform and designed to provide connected results in under seven minutes, with a reportable range of 20-130 mmol/mol HbA1c (4.0% to 14.0% HbA1c).
After listing on the Nasdaq market on May 18, Hong Kong-based diagnostics and genetic testing company Prenetics Group Ltd. saw its shares fall nearly 30% in early trading, dropping from $8.40 per share on listing to $5.70 by the end of trading May 19. Trading under the ticker PRE, Prenetics formed a merger with Artisan Acquisition Corp., a special purpose acquisition company, which was founded by entrepreneur Adrian Cheng. The transaction values Prenetics at an enterprise value of $1.25 billion, making the company the first Hong Kong unicorn to list on the Nasdaq.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anika, Nanomix, Trinity Biotech.
The Biden administration recently reported that a new round of free rapid tests for the SARS-CoV-2 virus is available to the public, a development that coincides with a new surge of the latest sub-variant of the omicron variant. However, the administration is also expected to renew the public health emergency (PHE) for the pandemic, even as the White House continues to press Congress for another $22 billion in pandemic-related funding.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accelus, Cepheid, Neuromatrix.
A year after the World Health Organization's (WHO) Independent Panel for Pandemic Preparedness and Response called for reforms to make COVID-19 the last pandemic, the panel remains solidly frustrated in its lack of progress.
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