Policy & Regulation: Page 2

Vaccine makers prepare response as coronavirus mutations raise alarms

So far, both Pfizer's and Moderna's vaccines appear to work against more transmissible variants, but preparation is underway for the day they don't.

By Jonathan Gardner • Jan. 28, 2021

Biden invokes DPA to combat supply shortages, but experts say it's no 'magic wand'

AdvaMed early in the pandemic urged against using the Defense Production Act's powers, though some companies were more open. The device lobby last week asked the administration to coordinate with industry before taking action.

By Matt Leonard • Jan. 27, 2021

Explore the Trendline➔

Trendline

The MedTech Dive Outlook on 2021

The pandemic will keep disrupting the industry in the year ahead, as COVID-19 testing wanes and elective procedures slowly ease back. We look at the risks, challenges and opportunities.

By MedTech Dive staff

4 key trends for payers and providers in 2021

The COVID-19 crisis may spur speedier adoption of value-based care and partnerships between health systems and payers in the year ahead.

By Samantha Liss • Jan. 22, 2021

Q&A

ACLA seeks lab reimbursement changes as need for COVID-19 testing surges

Julie Khani, president of the American Clinical Laboratory Association, which includes Quest and LabCorp, says there are coverage gaps and that clarifications are needed for which tests are paid for by insurers.

By Greg Slabodkin • Jan. 22, 2021

Biden appoints Janet Woodcock as acting FDA chief, plans COVID-19 testing board

The longtime agency staffer is reportedly being considered to permanently fill the role. The president also named acting directors for HHS and CMS.

By Shannon Muchmore • Jan. 21, 2021

Abbott antigen test misses two-thirds of COVID-19 asymptomatic cases: CDC

Compared to gold standard PCR tests, the company's point-of-care BinaxNOW diagnostic had a 35.8% sensitivity when used to analyze samples taken from individuals without symptoms, according to the agency.

By Nick Paul Taylor • Jan. 21, 2021

FDA breakthrough nods go to Alzheimer's devices, cardiovascular products

Cognito and Boston Scientific-backed Functional Neuromodulation picked up agency designations, positioning them for speedy reviews as they work to get their Alzheimer offerings to market.

By Nick Paul Taylor • Jan. 20, 2021

CMS expands transcatheter mitral coverage, boosting Abbott's MitraClip device

Wall Street analysts said the national coverage determination could triple the patient base eligible for Abbott's MitraClip device, adding fuel to a growing and under-penetrated market.

By Ricky Zipp • Jan. 20, 2021

CMS rejects 1st colorectal cancer blood test, tweaks path for Exact, Guardant and others

The agency removed one of the criteria needed to secure Medicare coverage but still shunned Epigenomics' diagnostic. Rivals have versions in development.

By Nick Paul Taylor • Jan. 20, 2021

MedTech Europe calls for EU to retain support for digital health post-pandemic

The industry wants reimbursement changes and other measures to make digital health permanent.

By Nick Paul Taylor • Jan. 19, 2021

Abbott, Quidel tout big COVID-19 testing year despite vaccine rollout: JPM21

"I don't see COVID just simply going away, but I do see it looking more like a flu-like seasonal test. And if you think about it globally, it's a pretty significant amount of volume," Abbott CEO Robert Ford said at J.P. Morgan's conference.

By Greg Slabodkin • Jan. 15, 2021

Google calls Fitbit acquisition complete despite ongoing DOJ review

The search giant closed the deal because the department's 14-month investigation period expired without any objection. However, DOJ could still sue to unwind the buy.

By Rebecca Pifer • Jan. 14, 2021

Pandemic propels health systems to mull insurer acquisitions, partnerships: JPM21

Advocate Aurora CEO Jim Skogsbergh said "partnering for health plan capability is going to be critical to our success."

By Samantha Liss • Jan. 14, 2021

FDA issues action plan for regulating AI in medical devices

The proposal brings the agency a step closer to draft guidance for regulating the fast-evolving field of artificial intelligence and machine learning-based software in medical devices.

By Susan Kelly • Jan. 13, 2021

CMS breakthrough rule called tailwind for Abbott, J&J and Medtronic

The policy gives developers of FDA-designated breakthrough products coverage for Medicare's 60 million beneficiaries on the day of approval.

By Nick Paul Taylor • Jan. 13, 2021

In medtech win, MDR-IVDR remote audits OK'd amid pandemic pressures

An official for MedTech Europe, which pushed for flexibility ahead of new medical device rules set to kick in later this year, called the move "significant and positive."

By Nick Paul Taylor • Jan. 12, 2021

California proposes expanding Medicaid coverage of continuous glucose monitors

The budget proposal seeks to increase access to CGMs among adults with Type 1 diabetes covered by the state's Medicaid program Medi-Cal. Abbott, Dexcom, Medtronic and Senseonics compete for the U.S. CGM market.

By Nick Paul Taylor • Jan. 11, 2021

FDA flags COVID-19 false negative risk from virus variant of Thermo Fisher, Applied DNA and Mesa tests

Sensitivity may be affected by emerging forms of the virus, though the agency said "the impact does not appear to be significant." In fact, the tests may help to spot where a fast-spreading variant is prevalent.

By Nick Paul Taylor • Jan. 11, 2021

HHS allocates $300M for Abbott COVID-19 rapid tests or 'equivalent' testing tech

The agency has yet to decide if it will purchase Abbott's or a similar diagnostic from a rival, Assistant Secretary for Health Brett Giroir said Thursday.

By Greg Slabodkin • Jan. 08, 2021

FDA tracks impact of COVID-19 mutations on test performance

The agency is concerned existing tests might miss new variants, Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, said. Thermo Fisher's Taqpath COVID-19 assay may detect the U.K. version. 

By Greg Slabodkin • Jan. 07, 2021

FDA finalizes speedier medical device pathway alternative to breakthrough status

Final guidance for the voluntary Safer Technologies Program features changes to draft sections criticized by AdvaMed, specifically what qualifies as a "significant" improvement to patient safety.

By Nick Paul Taylor • Jan. 06, 2021

FDA flags false negative risk of startup Curative's COVID-19 test

The Los Angeles-based firm was founded in January 2020 to focus on sepsis but has since pivoted to focus on coronavirus. Justin Mateen, founder of dating app Tinder, is its lead investor, according to Crunchbase.

By Nick Paul Taylor • Jan. 05, 2021

Hospitals lose another attempt to stave off price transparency

A judge wrote that the American Hospital Association's arguments, including that some rates are unknowable, "miss the mark." Facilities are now set to disclose base rates for items and services as of Jan. 1.

By Samantha Liss • Jan. 04, 2021

Brexit deal creates regulatory barriers to UK-EU medical device trade

The new arrangement lacks provisions for the mutual recognition of standards, forcing products made in the U.K. to undergo an extra certification step to enter the EU market.

By Nick Paul Taylor • Jan. 04, 2021

FDA 2020 recall roundup: A rough year for infusion pumps

The agency listed a total of nine entries for recalls of infusion pumps or components and one update of an earlier action, for models made by Baxter, BD, CME America and Smiths Medical. BD's Alaris line accounted for half. 

By Susan Kelly • Dec. 23, 2020