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Enforcement & Litigation

Set Alert for Enforcement and Legislation

Jury Awards Nearly $334M To MGI Tech In Illumina Patent Suit

The jury said the infringement, which involved patents on two-channel sequencing chemistry technology, had been “willful” and turned down Illumina’s counterclaims. 

Legal Issues Intellectual Property Commercial

Company Faces False Claims Charges For Disposable Rectal Probe Reuse

The Prometheus Group reportedly told health care providers that they could reuse probes that were part of its pelvic floor therapy system on multiple patients by covering them with a condom or the finger of a rubber glove.

Legal Issues Regulation

Philips Breathing Machines Recall: 21,000+ Adverse Events Reported To FDA In 1 Year

The tens of thousands of Medical Device Reports sent to the US agency included 124 reports of death associated with Philips’ June 2021 recall of millions of BiPAPs, CPAPs, and other mechanical ventilator devices.

Recalls Safety

Federal Small Business Research Grant Programs At Risk Of Expiration, AdvaMed Says

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs will shut down on 30 September if Congress doesn’t act to renew them – but some US senators say the programs are wasteful and may funnel research overseas. 

Policy Research & Development

Senate Bill Establishes Greater Regulatory Oversight Of Lab Developed Tests

Draft legislation out of the US Senate Health, Education, Labor and Pensions (HELP) Committee gives the FDA authority to regulate certain in vitro diagnostics known as laboratory developed tests.

FDA In Vitro Diagnostics

Digital Health Roundup: AI Trends In Medtech; Exec Chats; FDA’s Digital Health Guru Steps Down

In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights AI trends in medtech, Exec Chats with iRhythm and medical robotics authority Moshe Shoham, and key FDA updates.

Artificial Intelligence Digital Health

US To Share Its COVID-19 Technologies With World, Biden Says

During the second global COVID-19 summit, US President Joe Biden pledged to share essential technologies across the globe to fight the pandemic.

Coronavirus COVID-19 Vaccines

Lawyers Seek Clients For Possible Securities Fraud Case Against Dentsply Sirona

An internal investigation found that the company’s leadership may have directed employees to improperly account for sales-incentive payments. As a result, the company has been unable to file its quarterly report for the first quarter of 2022 with the SEC.

Legal Issues Dental Oral

QUOTED. Cathy McMorris-Rodgers.

US House of Representatives Energy and Commerce committee ranking member Rep. Cathy McMorris-Rodgers, R-WA, raised questions about the $3bn earmarked for new health research agency ARPA-H during user fee hearings on 11 May.

Quoted Legislation
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