FDA: Page 56
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Jacob Bell/MedTech Dive
FDA appoints first medical device cybersecurity chief
University of Michigan professor Kevin Fu will serve a one-year term as acting cyber director at the Center for Devices and Radiological Health. Experts fear the chaos of the pandemic creates the perfect storm for hackers to exploit.
By Greg Slabodkin • Feb. 3, 2021 -
Death, injuries prompt FDA to call Boston Scientific ICD recall Class I event
The device giant began recalling the subcutaneous implantable defibrillator system electrode late last year after learning of 26 serious injuries and one death associated with the device.
By Nick Paul Taylor • Feb. 3, 2021 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Courtesy of Ellume Health
DoD awards Ellume $231M to increase US production of at-home, OTC COVID-19 test
The Australian diagnostics company will use the funding to establish a U.S. manufacturing facility that is projected to increase production capacity by 640,000 tests per day by December.
By Susan Kelly • Feb. 2, 2021 -
How might Xavier Becerra operate as HHS Secretary?
The nominee has made headlines since leaving the House of Representatives, in part by leading blue state efforts to defend the ACA. Less high-profile, perhaps, were his efforts to block major hospital mergers in California.
By Ron Shinkman • Feb. 1, 2021 -
Deep Dive
3 big predictions for digital health in 2021
As tech and data sharing become more pervasive, healthcare will likely pivot to being more predictive and telehealth will evolve, giving rise to new modalities of care. This will force companies to invest more in cybersecurity.
By Rebecca Pifer • Jan. 29, 2021 -
Low Medicare EKG device draft slams iRhythm, stock price sinks by over 30%
Wall Street analysts questioned whether the lower-than-expected rates are final and what the prospects are for renegotiation. Shares of market leader iRhythm fell over 32% on Friday.
By Ricky Zipp • Updated Feb. 1, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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 -
Courtesy of BioNTech
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 -
Brian Tucker/MedTech Dive
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 -
"State Public Health Laboratory in Exton Tests for COVID-19" by Governor Tom Wolf is licensed under CC BY 2.0
Q&AACLA 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 -
Courtesy of Abbott Labs
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 -
Yujin Kim/MedTech Dive
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 -
"State Capitol Building, USA, California, Sacramento" [Photograph]. Retrieved from Pixy.
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 -
Jacob Bell/MedTech Dive
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 -
"White House Press Briefing". Retrieved from The White House.
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. 8, 2021
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