Topic: FDA

BioVentrix is getting closer to bringing its transcatheter-based structural cardiovascular device to treat heart failure […]

Medtronic topped estimates in its latest earnings quarter. The Dublin-based company brought in earnings per […]

Dive Brief: FDA’s effort to launch a new pathway to market for devices “reasonably expected […]

The fate of the medical device industry’s most widely used sterilization process lies in the […]

The FDA today announced that it has cleared a duodenoscope from Hoya’s (TYO:7741) Pentax subsidiary that has […]

Axonics Modulation Technologies (NSDQ:AXNX) announced today that it won FDA premarket approval for its r-SNM sacral […]

Guardant Health isn’t a static company. Ever since it was formed by Helmy Eltoukhy, and […]

Dive Brief: FDA granted breakthrough device designation to AI Medical Service’s technology for diagnosing gastric […]

We already know that cybersecurity is one of the biggest issues keeping medtech manufacturers awake […]

An FDA panel will meet this week to discuss immunological responses to medical device implants […]

Royal Philips (NYSE:PHG) issued an urgent field safety notice for its V60 ventilators after issues arose […]

AI Medical Service, a Tokyo-based startup announced Monday that the Food and Drug Administration has […]

The FDA has given a recall on the Zimmer Biomet (NYSE:ZBH) Rosa Brain 3.0 devices […]

Dive Brief: Leading manufacturers of paclitaxel-coated balloons and stents to treat peripheral artery disease (PAD), […]

Dive Brief: In back-to-back earnings reports, insulin pump makers Tandem Diabetes and Insulet each topped […]

Dive Brief: FDA reminded healthcare providers of a year-end deadline to return Essure birth control devices […]

Dive Brief: FDA categorized Abbott’s recall of its CentriMag ​Acute Circulatory Support System as a […]

Dive Brief: FDA awarded breakthrough designation to Colorado Springs, Colo.-based Med-botics’ Oxalert Enhanced Pulse Oximeter […]

Dive Brief: FDA has categorized Johnson & Johnson unit Ethicon’s recall of its Echelon Flex Endopath […]

Dive Brief: FDA on Monday alerted patients and healthcare providers that new data it is […]

Dive Brief: FDA awarded breakthrough status to Minnesota medtech Surmodics’ sirolimus-coated balloon catheter, the company said Tuesday. […]

HeartVista said today that it won FDA 510(k) clearance for its AI-assisted One Click MRI acquisition […]

Medtronic (NYSE:MDT) said today that it won breakthrough device designation from the FDA for its fully […]

Dive Brief: A treatment protocol that includes proper patient selection and early identification of right-sided […]

Hancock Jaffe Laboratories (NSDQ:HJLI) said yesterday that six-month data from its in-human VenoValve study showed that […]

Fresenius Medical Care North America (NYSE:FMS)  said today that it won breakthrough device designation from the […]

Dive Brief: Fresenius Medical Care received FDA’s breakthrough device designation for a new hemodialysis system, […]

Garwood Medical Devices has been granted “Breakthrough Devices” designation from the U.S. Food and Drug […]

The Medical Device Innovation Consortium (MDIC) has been awarded $2.8 million in funding by the […]

Garwood Medical Devices said today that it has won FDA breakthrough device designation for the BioPrax […]

Novo Nordisk (NYSE:NVO) said today that it won an expanded label from the FDA for its […]

Aptar Pharma has entered an agreement for Bryn Pharma to use Aptar’s Bidose (BDS) nasal device to deliver […]

Clearside Biomedical (NSDQ:CLSD) last week said that the FDA found no efficacy issues with its Xipere […]

Dive Brief: A bipartisan pair of senators is urging FDA to provide details on its […]

Dive Brief: Corvia Medical received FDA’s breakthrough device designation for its interatrial shunt device for […]

Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA […]

Dive Brief: Ancestry announced Tuesday it’s getting into the genetic health testing space with the […]

Last month, Medtronic announced receipt of U.S. Food and Drug Administration (FDA) approval for and […]

The FDA has issued two new final guidance documents governing labels for a variety of […]