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HLTH 2020: Amwell CEO Foresees Patient Demand Will Drive Telehealth’s Future

The COVID-19 pandemic has accelerated the rise of telemedicine, but the conversation about how telehealth will fit into the overall health system continues, said Amwell co-CEO and president Roy Schoenberg ..... see more

Source : Medtech Insight

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US Election 2020: Here’s Who Industry’s Donating To

As in prior elections, medtech companies and industry groups are throwing their support and political action committee (PAC) dollars to a slate of incumbent senators running tough campaigns against their ..... see more

Source : Medtech Insight

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Interview: Diagnostics' Vital Role Is Something to Shout About, Says UK's BIVDA

In mid-September, the British In Vitro Diagnostics Association found itself defending manufacturers and suppliers of diagnostic testing supplies and government coronavirus testing policy, after a resurgence in the virus led ..... see more

Source : Medtech Insight

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11 New Telehealth Services Will Be Payable By CMS During Pandemic, Agency Says

The US Centers for Medicare and Medicaid Services is increasing the number of telehealth services it will reimburse by 11 new services, the agency announced on 14 October. Among the ..... see more

Source : Medtech Insight

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US Salon Sector Appears On Track To Recover, Kline Says

US salon services in the 2020 second quarter generated just over a third of revenue seen in the comparable 2019 quarter, according to consulting and research firm Kline.The result shows ..... see more

Source : 'HBW Insight'

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Real-World Evidence Uptake Is “Silver Lining” Of COVID-19 Response, USFDA’s Abernethy Says

Drug development during COVID-19 has forced the US Food and Drug Administration and sponsors to accelerate their understanding and adoption of real-world evidence, given the challenges in conducting clinical trials ..... see more

Source : 'The Pink Sheet'

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Coronavirus Update: After FDA Sneaks Out Guidance, Trump’s Vaccine Dream Is Over

President Trump’s hopes of having a COVID-19 vaccine ready ahead of election day have been dashed after the US Food and Drug Administration issued guidance which makes an emergency authorization ..... see more

Source : 'Scrip Intelligence'

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How Much Should Governments Pay For COVID-19 Monoclonal Antibody Therapies?

The public spotlight has turned toward monoclonal antibody therapies for COVID-19 following President Trump’s recent treatment with Regeneron Pharmaceuticals, Inc.’s experimental cocktail and Eli Lilly and ..... see more

Source : 'The Pink Sheet'

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Transparency, And A Mirror: US FDA Advice On COVID-19 Vaccine EUAs Finally Published – Twice

The US Food and Drug Administration’s advice on the evidence needed to support an emergency use authorization for a COVID-19 vaccine is apparently so nice that the agency released it ..... see more

Source : 'The Pink Sheet'

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US FDA ‘Flexible’ With Vaccine Safety Data Requirements, CBER’s Peter Marks Says

US Food and Drug Administration officials may allow some wiggle room with the coronavirus vaccine safety recommendations that garnered the ire from the White House in recent days.The expectation for ..... see more

Source : 'The Pink Sheet'

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COVID-19 Contracting Accelerated As US Fiscal Year 2020 Drew To A Close

The coronavirus pandemic generated a flurry of US government contracting activity as fiscal year 2020 ended 30 September.There were additional contracts with Pfizer Inc., Fresenius Kabi ..... see more

Source : 'The Pink Sheet'

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VP Debate: Pence Tries Vaccine Hesitancy Jujutsu On Harris

The Japanese martial art Jujutsu is characterized by techniques that attempt to turn an opponents’ moves back in on themselves, not so much using your own force but getting your ..... see more

Source : 'The Pink Sheet'

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FDA Stops Granting EUAs For Lab Developed Tests, Denying LDT Makers PREP Act Liability Protections

The push-and-pull between the US Department of Health and Human Services and the Food and Drug Administration over laboratory developed tests took a surprising turn today when the agency declared ..... see more

Source : Medtech Insight

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87636 And 87637: New CPT Codes From AMA For COVID-19/Flu Combo Antigen Tests

The American Medical Association (AMA) has added two new Current Procedural Terminology (CPT) codes for reporting antigen tests that detect both COVID-19 and influenza.Effective immediately, the new Category I CPT ..... see more

Source : Medtech Insight

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Medtech CEOs Predict Diminished Role For Hospitals In The Future Of Surgery

Medtech leaders expect the business of selling surgical devices will be permanently changed by the COVID-19 pandemic. “It's going to be a very significant difference, not only in medicine or ..... see more

Source : Medtech Insight

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Coronavirus Update: As Trump Leaves Hospital, White House Blocks FDA Vaccines Guidance

New guidelines which would raise the efficacy and safety standards required for COVID-19 vaccines to gain emergency use approval are being blocked by the White House.A report in the New ..... see more

Source : 'Scrip Intelligence'