A study of 14,228 bronchoscopy procedures found sterile, disposable scopes reduced readmission rates by more than half. The study, authored by Ambu consultant Dr. Hudson Garrett, analyzed procedures at inpatient hospitals as well as outpatient ambulatory facilities. He found that 3.6 percent of patients treated with a single-use, flexible bronchoscope were readmitted within 30 days, […]
FDA
Luminopia’s new FDA-approved therapy uses TV to treat lazy eye in kids
Luminopia announced today that it received FDA de novo approval for its prescription therapy for improving vision in children with lazy eye. Cambridge, Massachusetts-based Luminopia’s prescription Luminopia One holds indication for improvement in visual acuity in children between ages four and seven with lazy eye (amblyopia) associated with anisometropia and/or mild strabismus, having received treatment instructions […]
FDA hits pause on reviewing Moderna COVID-19 vaccine for adolescents
The FDA has decided to postpone deciding whether to extend emergency use authorization of Moderna’s (NSDQ:MRNA) COVID-19 vaccine. Some regulators have concluded that the risk of myocarditis is higher in recipients of the Moderna vaccine than the Pfizer-BioNTech vaccine. Japan recently authorized men 30 and under who received an initial dose of the Moderna vaccine […]
Varian wins FDA breakthrough nod for microspheres that treat knee osteoarthritis
Varian announced today that it received FDA breakthrough device designation for its Embozene microspheres for treating knee osteoarthritis. Palo Alto, California-based Varian, a Siemens Healthineers (ETR:SHL) company, designed Embozene for genicular artery embolization (GAE) in treating symptomatic knee osteoarthritis. Embozene already holds FDA clearance for the embolization of hypervascular tumors, arteriovenous malformations, uterine fibroids and benign […]
Life Spine wins FDA clearance for ProLift micro expandable spacer
Life Spine announced that it received FDA clearance to market its ProLift micro expandable spacer system for supporting micro-invasive procedures. Huntley, Illinois-based Life Spine designed its ProLift micro to support procedures ranging from endoscopic TLIFs to MIS TLIFs/PLIFs. The platform includes an 8mm width, self-locking expansion at any height (between 8mm and 16mm) to suit the […]
Insulet CEO Shacey Petrovic touts Omnipod 5, expects device launch this year
With FDA clearance imminent, Petrovic says Insulet’s latest device offers real change in diabetes care. Faced with either a bulky insulin pump or delivering multiple daily injections, Boston-based entrepreneur and venture capitalist John Brooks III sought an easier way to treat his young son’s newly diagnosed type 1 diabetes. He assembled a team of engineers […]
Delphinus wins FDA approval for whole breast ultrasound tomography system
Delphinus Medical Technologies announced today that it received FDA premarket approval (PMA) for its SoftVue system. Novi, Michigan-based Delphinus develops the SoftVue 3D whole breast ultrasound tomography system for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue, according to a news release. The company said SoftVue […]
FDA to make decision on Corium’s transdermal patch for treating dementia next year
Corium (NSDQ:CORI) announced today that the FDA set a Prescription Drug User Fee (PDUFA) target action date for its Adlarity system. The FDA set the PDUFA target action date for Adlarity (donepezil transdermal system), a transdermal patch designed to treat dementia or Alzheimer’s disease, for March 11, 2022. Get the full story at our sister site, […]
Pfizer officially asks FDA to expand COVID-19 vaccine access to younger kids
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that they submitted a request to the FDA to expand the authorization of their COVID-19 vaccine to younger children. Expanded FDA emergency use authorization would allow for the use of the COVID-19 vaccine candidate, which has full FDA approval for people 16 years of age and older, in children aged […]
FDA grants EUA for PerkinElmer’s combination COVID-19, flu, RSV diagnostic
PerkinElmer (NYSE:PKI) announced today that it received FDA emergency use authorization (EUA) for its PKamp respiratory panel 1 assay. Qualified laboratories can now use Waltham, Massachusetts–based PerkinElmer’s PKamp respiratory SARS-CoV-2 RT-PCR panel 1 assay to simultaneously test for several serious respiratory ailments. The assay can detect SARS-CoV-2 (the virus causing COVID-19), influenza A, influenza B […]
FDA offers expanded clearance for DreaMed’s AI-based support system for type 2 diabetes
DreaMed Diabetes AI announced today that it received FDA clearance that expands its platform’s target population to cover type 1 and type 2 diabetes. Tel Aviv, Israel-based DreaMed’s Advisor Pro AI clinical decision support system assists healthcare providers in the management of diabetes patients who use insulin pumps or injections and monitor their glucose using a […]