Topic: FDA

Baxter (NYSE:BAX) announced today that it received FDA emergency use authorization (EUA) for its HF20 Set […]

Dive Brief: BD plans to submit an updated 510(k) filing to the FDA for its […]

Stryker announced that it has received US Food and Drug Administration (FDA) approval for an […]

Abiomed (NSDQ:ABMD) announced today that the FDA issued emergency use authorization (EUA) for its Impella heart […]

Medtronic and Axonics have been going toe-to-toe in sacral neuromodulation — a fast-growing market that was monopolized by […]

GE Healthcare (NYSE:GE) announced that it will exclusively distribute the DyeVert portfolio for imaging technology developer Osprey […]

Dive Brief: Johnson & Johnson has secured FDA breakthrough device designation for transbronchial microwave ablation […]

The FDA has authorized its first COVID-19 diagnostic for broad-based screening—including for people who have […]

Dive Brief: FDA on Tuesday published final guidance explaining its policies and regulatory review practices for […]

It’s hard to think of a product category more critical to America’s ongoing public health […]

Palliare announced today that it received FDA 510(k) clearance for its EVA15 insufflator and smoke evacuation […]

Abbott (NYSE:ABT) announced today that it received FDA approval for the use of its Patient Controller […]

In 2014, ReWalk Robotics won FDA clearance for the home use of its personal exoskeleton. […]

Boston Scientific has won a nod from FDA for the latest generation of the Watchman […]

Johnson & Johnson (NYSE:JNJ)  has decided not to follow a 510(k) clearance pathway for its planned […]

Dive Brief: Johnson & Johnson has changed earlier plans to seek U.S. marketing authorization for […]

Dive Brief: FDA has proposed changes to its guidance on the development of medical devices […]

Dive Brief: Abbott has laid out plans to begin a U.S. study this month of […]

FDA has a goal of restarting on-site inspections during the week of July 20 — […]

Baxter (NYSE:BAX) announced today that it received FDA clearance for its Altapore Shape bioactive bone graft […]

Soterix Medical announced today that it received FDA investigational device exemption (IDE) to launch a trial […]

Dive Brief: FDA raised concerns Monday about an increased rate of false positives associated with […]

Berlin Heart announced today that it completed the post-approval surveillance process for its Excor pediatric ventricular […]

WHITE BEAR LAKE, Minn.–(BUSINESS WIRE)–Envoy Medical® Corporation, a hearing health company focused on providing innovative […]

Dive Brief: A final rule from the EPA on commercial sterilizers that use ethylene oxide […]

Dive Brief: FDA has decided to delay the enforcement of unique device identification (UDI) requirements […]

Dive Brief: A top spokesperson for HHS tweeted Monday night the department “expects to renew” […]

Danaher subsidiary Beckman Coulter has joined the ranks of major diagnostics manufacturers with FDA’s go-ahead […]

Masimo (NSDQ:MASI) announced that it received FDA de novo classification for its Bridge neuromodulation-based opioid withdrawal […]

Dive Brief: HHS’ Biomedical Advanced Research and Development Authority said Tuesday it is working with […]

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott […]

The head of the FDA says some changes the agency made during the height of […]

Imagine being in the middle of a financing round to help commercialize technology that has […]

Dive Brief: Thermo Fisher Scientific said Monday its assay to identify two mutations in patients with […]

Dive Brief: Digital therapeutics developer Akili Interactive Labs received De Novo authorization Monday from FDA […]

Proteus Digital Health, maker of an ingestible sensor for tracking medication adherence, filed for Chapter […]

FDA gave Illumina the greenlight to bring the first next-generation sequencing COVID-19 diagnostic test to the […]

Royal Philips joins the list of companies taking advantage of the relaxed FDA guidelines with its […]

Bigfoot Biomedical has brought on Dr. Jim Malone — a 21-year clinical research veteran at […]