The FDA today issued its first emergency use authorization for a molecular COVID-19 diagnostic test for at-home use without a prescription. The Cue Health COVID-19 Test for Home and Over The Counter (OTC) use is a molecular nucleic acid amplification test designed to detect genetic material from the SARS-CoV-2 virus in the nostrils. The authorized […]
Regulatory/Compliance
Second Sight gains FDA nod for retinal system that may never be produced
Second Sight Medical (NSDQ: EYES) today announced that the FDA has approved its Argus 2s retinal prosthesis system, but questions remain about whether it will ever be manufactured. The past year has been tough for Second Sight. The company announced in March 2020 that it would wind down its operations amid the financial shock of […]
Abbott wins EUA for COVID-19, flu, RSV combo assay
Abbott (NYSE:ABT) announced today that it received FDA emergency use authorization (EUA) for its Alinity m Resp-4-Plex molecular assay. The laboratory PCR diagnostic is designed to detect and differentiate between SARS-CoV-2 (the virus causing COVID-19), influenza A, influenza B and respiratory syncytial virus (RSV) in one test. It already has CE Mark approval and is […]
ControlRad gains clearance for imaging tech to sell to Boston Sci
ControlRad announced today that it received FDA 510(k) clearance to market its ControlRad Select radiation reduction technology. Atlanta-based ControlRad’s technology uses proprietary semi-transparent filters with a user-interface tablet and imaging processing algorithms that are retrofitted onto customers’ existing Siemens Artis zee interventional imaging systems, according to a news release. ControlRad, ahead of its commercialization efforts […]
FDA clears once-daily ADHD capsule from Corium
Corium (NSDQ:CORI) announced today that it received FDA approval for its once-daily Azstarys oral capsule for treating ADHD symptoms. Boston-based Corium touts its Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) drug as the first and only product containing a d-MPH oral prodrug for treating ADHD (attention deficit hyperactivity disorder) symptoms in patients aged six years and older, […]
Origami Surgical gains FDA clearance for robotic suturing devices
Origami Surgical today announced that the FDA has granted 510(k) clearance for three new types of sutures for its StitchKit robotic surgery platform. The company describes StitchKit as a patented suture delivery and retrieval system designed so sutures are efficiently inserted and needles are safely removed from the surgical field. StitchKit also allows the robotic […]
N.J. appeals court tosses $83M pelvic mesh verdicts against J&J, Bard
A New Jersey appeals court yesterday threw out jury verdicts totaling $83 million in separate pelvic mesh lawsuits against Johnson & Johnson’s (NYSE:JNJ) Ethicon division and Becton Dickinson (NYSE:BDX) subsidiary C.R. Bard. In both cases, Bergen County, N.J. judges erred by disallowing evidence showing that each company’s mesh product had received FDA 510 (k) clearance, according […]
Abbott COVID-19 serology test gains EUA
Abbott (NYSE:ABT) this week received FDA emergency use authorization (EUA) for its AdviseDx SARS-CoV-2 IgG II diagnostic — providing another tool to detect people’s adaptive immune response to COVID-19. The serology test from Abbott Park, Ill.-based Abbott is indicated for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 — the virus causing COVID-19 […]
Asensus Surgical wins FDA nod for general surgery with Senhance robotic surgery system
Asensus Surgical (NYSE:TRXC), formerly TransEnterix, announced that it won expanded FDA clearance for its Senhance surgical system. Research Triangle Park, N.C.–based Asensus Surgical’s Senhance surgical system, which it touts as the first-of-its-kind digital laparoscopic platform that leverages augmented intelligence to provide strong performance and positive patient outcomes through machine learning, now has FDA clearance for […]
Cook Medical wins FDA breakthrough device designation for next-gen endovascular graft
Cook Medical announced that FDA has granted breakthrough device designation for its Zenith Fenestrated+ endovascular graft (ZFEN+), the next-gen version of its Zenith Fenestrated AAA endovascular graft. The designation — a first for Bloomington, Ind.–based Cook Medical — will enable priority review and better communication with FDA during the clinical trial and premarket review phases. […]
FDA grants breakthrough nod to Anuncia’s cerebral spinal fluid treatment
Anuncia announced today that it received FDA breakthrough device designation for its ReFlow system for cerebral spinal fluid (CSF) management. Lowell, Mass.-based Anuncia’s ReFlow Mini is intended to treat CSF disorders requiring shunting, including hydrocephalus, according to a news release. It has been optimized to serve a broad hydrocephalus population, including infants with non-communicating hydrocephalus, […]
