FDA Archives - Page 81 of 103 - Medical Design Sourcing

FDA clears Orthofix 3D-printed titanium cervical spacer system

Orthofix Medical (NSDQ:OFIX) announced today that it received FDA 510(k) clearance for its Construx Mini Ti spacer system.

Lewisville, Texas-based Orthofix also administered the first patient implant of the 3D-printed Construx Mini Ti system, which is designed to enhance anterior cervical discectomy and fusion (ACDF) procedures, according to a news release.

The Construx Mini Ti cervical spacer includes Nanovate technology is touted as the first 3D-printed titanium interbody implant to be introduced onto the market by Orthofix.

Endplates of the implants showed a significant increase in growth factors involved in osteogenesis and osteoblast maturation, resulting in more favorable osteogenic environment for bone ingrowth, Orthofix said.

The system includes 3D-printed porous titanium with macro, micro and nanoscale surface features, the latter of which increases proliferation and alkaline phosphatase activity in human stem cells in vitro. Additionally…

FDA flags infection risk from reusable urological endoscopes

The FDA said today that is looking into the causes of infections from reprocessed urological endoscopes based on “numerous” adverse event reports.

The agency said that since 2017 it has received more than 450 medical device reports — including three deaths — associated with reprocessed cystoscopes, ureteroscopes and cystourethroscopes used for viewing and accessing the urinary tract. The reports describe post-procedure infections or “other possible contamination issues” associated with cleaning and disinfecting the devices.

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FDA authorizes use of over-the-counter COVID-19 tests for screening

The FDA announced today that it authorized several COVID-19 tests for over-the-counter use in asymptomatic screening.

Among the tests authorized were the BinaxNow Ag card from Abbott (which includes point-of-care screening), the Quidel Quick-View at-home test and the BD Veritor Plus system, which was authorized for POC screening with a prescription.

“BD is supporting the global efforts to return to normalcy as soon as possible, and this additional authorization for the BD Veritor system to be used in screening through serial testing of asymptomatic individuals is a large step forward,” BD life sciences president Dave Hickey said in a news release. “Frequent testing of individuals without symptoms will enable those with negative results to resume their normal school or work routines and will help to identify and isolate positive cases of COVID-19 as early as possible to prevent further spread.

“Screening through serial testing is a…

FDA warns on use of certain surgical mesh in breast reconstruction

Two brands of surgical mesh used off-label in breast reconstruction surgery have had “significantly higher major complication rates,” according to an FDA analysis.

Patients implanted with FlexHD by MTF Biologics and AlloMax by BD had higher rates of explantation, reoperations and infections two years after surgery when compared with patients who received one of two other brands of surgical mesh or no mesh, the agency said late yesterday.

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Abbott’s rapid COVID-19 self-test is now over-the-counter

The BinaxNow COVID-19 Ag Card [Image courtesy of Abbott]Abbott (NYSE:ABT) announced that it received FDA emergency use authorization (EUA) for over-the-counter use of its BinaxNOW COVID-19 test.

The new indication for the diagnostic allows individuals with or without symptoms to access the BinaxNOW COVID-19 Ag self test over the counter, without a prescription. The company plans to begin shipping to major food, drug and mass merchandiser retailers in the coming weeks and anticipates the test to be made available through some online stores, too, according to a news release.

Abbott Park, Ill.-based Abbott’s BinaxNOW test can be used on children as young as two years old when samples are collected by an adult, plus for all people aged 15 years or older. The rapid antigen test will come in a two-count box.

Those using the test will only need to perform a minimally invasive nasal swab, rather than a deep nasopharyngeal swab, with all materials required to …

FDA approves inhaled pulmonary hypertension treatment from United Therapeutics

Image from United Therapeutics

United Therapeutics (NSDQ:UTHR) announced today that it received FDA clearance for its Tyvaso inhalation solution for pulmonary hypertension.

Research Triangle Park, N.C.-based United Therapeutics’ Tyvaso (treprostinil) inhalation solution is designed to treat patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

BlueStar Genomics gains breakthrough nod for pancreatic cancer test

Bluestar Genomics announced today that it received FDA breakthrough device designation for its pancreatic cancer test.

San Diego-based Bluestar’s proprietary noninvasive pancreatic cancer detection test is designed for use with patients with new-onset diabetes, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

Pfizer, BioNTech report COVID-19 vaccine works well among adolescents

Image courtesy of Wikipedia

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that their COVID-19 vaccine produced 100% efficacy among adolescents.

In adolescents aged 12 to 15 years old with or without prior evidence of SARS-CoV-2 infection, the BNT162b2 vaccine demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants between 16 and 25. The vaccine was well-tolerated among the 2,260 adolescents participating in the Phase 3 trial, according to a news release.

The trial observed 18 cases of COVID-19 in the placebo group (1,129 patients) compared to zero in the vaccinated group (1,131 patients). The vaccine elicited neutralizing antibody geometric mean titers (GMTs) of 1,239.5 at one month after the second dose. Participants between 16 to 25 in earlier analysis produced GMTs of 705.1, demonstrating the effectiveness among adolescents.…

3M, others may have unmasked a solution to future N95 shortages

A handful of companies including 3M are working to ensure that a scramble for disposable masks never happens again.

MSA Advantage elastomeric respirator (Image courtesy of MSA Safety)

The face of the next pandemic could be very different than that of COVID-19, thanks to a handful of companies that have redesigned reusable industrial face masks to better protect healthcare workers and help prevent mask shortages.

The makers of reusable elastomeric half-mask respirators designed them for industrial use with two inhalation valves flanking an exhalation valve. The exhalation valve enables wearers to breathe out comfortably and keeps the rubber masks from becoming too hot. Some healthcare workers began wearing them during the COVID-19 pandemic, but in June, the FDA stopped allowing the use of masks with exhalation valves in healthcare settings because they may spread virus particles from infected wearers.

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FDA clears point-of-care STI test

The FDA announced today that it authorized the Binx Health IO CT/NG assay at point-of-care settings to diagnose STIs.

Point-of-care settings include physician offices, community-based clinics, urgent care settings, outpatient healthcare facilities and other patient care settings operating under a CLIA certificate of waiver, certificate of compliance or certificate of accreditation, according to a news release.

The test uses female vaginal swabs and male urine specimens to detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which case the sexually transmitted infections (STIs) chlamydia and gonorrhea, respectively.

While the patient is present, the test is performed and it provides an actionable result within approximately 30 minutes. The test was evaluated in females 16 years of age and older and in males 17 and up and was demonstrated to be comparable to tests performed in a CLIA certified laboratory that meets requireme…

FDA committee to examine safety of endovascular stent grafts

AFX Endovascular AAA system [Image courtesy of Endologix]FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies.

Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially higher-than-expected risk of blood leakage called Type III endoleaks. Endologix has found itself having to vigorously defend itself against studies claiming a problem.

The FDA is presently advising that anyone with any Endologix AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) visits a doctor at least once a year to get checked for leaks.

Another Endologix product — the Ovation iX abdominal stent graft system — was the subject of a Class I recall last year including five deaths, though Endologix clarified that two of the five deaths took place follo…

Helius Medical wins FDA nod for tongue stimulator that improves MS patients’ gait

The FDA announced today that it authorized marketing for a stimulator device that treats gait deficit in those with multiple sclerosis (MS).

Helius Medical’s portable neuromodulation stimulator (PoNS) is a neuromuscular tongue stimulator that uses a non-implantable apparatus to generate electrical pulses for stimulation of the trigeminal and facial nerves via the tongue to treat motor deficits, according to an FDA release.

PoNS is intended for prescription-only use as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older. It is a short-term treatment for gait deficit as a result of mild to moderate symptoms from MS.

The portable, non-implantable device includes a controller and a mouthpiece connected by a cord. The mouthpiece is held lightly in place by the lips and the control unit is worn around the neck during a patient’s visit with a therapist.

Signals are sent from the controller to the mout…