FDA: Page 57
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FDA approves 3D-printed ankle implant for humanitarian use
Additive Orthopaedics makes the devices from cobalt chromium alloy to treat avascular necrosis, a rare bone disease. It is the first patient-specific total talus replacement implant approved by the agency.
By Nick Paul Taylor • Feb. 18, 2021 -
COVID-19 EUAs drive FDA to record 2020 novel device OKs
The tally tops the 106 novel device authorizations in 2018 that marked a 40-year high.
By Susan Kelly • Feb. 17, 2021 -
Explore the Trendlineâž”
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 -
One-third of US adults postponed care during pandemic: reports
Among those surveyed, 25% put off dental care, while 21% put off checkups and 16% put off screenings or medical tests, researchers from the Urban Institute and RWJF found.
By Ron Shinkman • Feb. 16, 2021 -
Jacob Bell/MedTech Dive
BD drug-coated balloon faces uphill battle in FDA panel review
Advisers on Wednesday are weighing the PAD treatment, but the agency has said data limitations make it hard to draw conclusions about safety and effectiveness. Evercore ISI analysts predict a negative vote.
By Susan Kelly • Updated Feb. 17, 2021 -
FDA admits COVID-19 antibody test policy was 'flawed,' offers lessons for future outbreaks
Writing in the New England Journal of Medicine, agency officials acknowledged "touting the potential usefulness" of serology tests early in the pandemic contributed to flooding the market with poorly performing diagnostics.
By Nick Paul Taylor • Feb. 16, 2021 -
In run-up to MDR, EU posts guide to legacy devices in Eudamed
The guidance explains when manufacturers need to register on the new database and walks through details such as how to link products covered by the outgoing and new regulatory frameworks.
By Nick Paul Taylor • Feb. 15, 2021 -
Visby gets FDA nod for single-use, rapid point-of-care COVID-19 PCR test
The palm-sized diagnostic gives results in 30 minutes without the need for additional instruments or readers. While Abbott's ID Now provides results in 13 minutes or less, it is the size of a toaster and requires a cartridge.
By Greg Slabodkin • Feb. 10, 2021 -
Jacob Bell/MedTech Dive
Heart disease devices lead latest batch of FDA breakthrough nods
The cardiovascular-focused products are part of a wider group of designations including those in development at companies such as Roche.
By Nick Paul Taylor • Feb. 10, 2021 -
Medicare DME competitive bidding in doubt after failed round: analysts
Cowen analysts said a recent report found steep rate hikes, leading them to conclude the program is no longer such a big threat to companies like Baxter, ResMed and Philips.
By Nick Paul Taylor • Feb. 8, 2021 -
FDA OKs Signifier neurostim device for snoring, sleep apnea
Signifier now faces the challenge of establishing eXciteOSA in the congested snoring and sleep apnea market targeted by companies including ResMed.
By Nick Paul Taylor • Feb. 8, 2021 -
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 -
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 Parduhn • 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
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