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BioWorld - Sunday, May 22, 2022
Home » Topics » Regulatory, BioWorld MedTech

Regulatory, BioWorld MedTech
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Singapore

Singapore updates guidelines for software as medical devices to expand scope

May 20, 2022
By David Ho
No Comments
Singapore’s Health Sciences Authority (HSA) recently updated its guidelines for software as medical devices (SaMDs) to broaden its scope on a number of related matters. The new guidelines were finalized after an industry input period when the HSA collected feedback until the middle of August 2021. It marks the second revision of HSA guidelines on SaMDs, the first revision was meted out in April 2020. 
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Regulatory actions for May 20, 2022

May 20, 2022
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anika, Nanomix, Trinity Biotech.
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White House touts new round of free tests as public health emergency poised for renewal

May 19, 2022
By Mark McCarty
No Comments
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.
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Woman on couch using tablet

Advertising and promotions still a major hazard for device makers

May 19, 2022
By Mark McCarty
No Comments
Device makers do not engage in direct-to-consumer advertisement at the same pace as drug makers, but advertising and promotions are still a minefield of potential enforcement action for the unwary manufacturer. According to Jesse Atkins and Nate Downing of Gardner Law in Stillwater, Minn., even a minor skirmish with the FDA can result in an extensive review of standard operating procedures, a potentially expensive and time-consuming distraction from companies fighting for market share in the hotly contested U.S. market.
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Regulatory actions for May 19, 2022

May 19, 2022
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accelus, Cepheid, Neuromatrix.
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Prometheus Group hit with federal lawsuit claiming violation of FCA

May 18, 2022
By Mark McCarty
No Comments
The U.S. Department of Justice (DOJ) has filed a complaint in U.S. district court related to marketing of a pelvic muscle rehabilitation system by the Prometheus Group of Raleigh, N.C., stating that the company encouraged health care professionals to reuse rectal pressure sensors and anorectal manometry catheters on multiple patients.
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Phlebotomist draws blood from patient

OIG says phlebotomy draw fee arrangement would run afoul of Anti-Kickback Statute

May 18, 2022
By Mark McCarty
No Comments
Clinical laboratories and hospitals have routine commercial interactions, and most of those are entirely legal, but this is not always the case. The Office of Inspector General (OIG) at the U.S. Department of Health and Human Services recently decreed that an arrangement in which the hospital pays the lab for blood specimen collection handling services, or a “draw fee,” would not be permissible under the Anti-Kickback Statute (AKS), reinforcing an existing understanding that such activities present a significant legal hazard for operators of clinical labs.
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05-18-Aptima-CMV-Box.png

FDA greenlights Hologic’s Aptima CMV Quant assay for transplant patients

May 18, 2022
By Annette Boyle
No Comments
Hologic Inc. received FDA premarket approval for its Aptima CMV Quant assay, which enables monitoring of viral loads of transplant patients with cytomegalovirus (CMV). While CMV typically poses little risk to adults with healthy immune systems, it can cause organ rejection and death in transplant patients if untreated. The assay gained a CE mark in June 2021.
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Global pandemic threat

Too little, too late: WHO panel says the world is vulnerable to another pandemic

May 18, 2022
By Lee Landenberger
No Comments
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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Regulatory actions for May 18, 2022

May 18, 2022
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Icad, Olympus, Robocath.
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