Topic: FDA

ICU Medical has issued an Urgent Medical Device Correction identifying that replacement batteries for its […]

The FDA approved Opvee nalmefene hydrochloride nasal spray for the emergency treatment of opioid overdoses […]

MicroPort CRM announced today that it received FDA approval for its Alizea and Celea implantable pacemakers. […]

Virtual Incision announced that it submitted its MIRA surgical robot to the FDA for de novo […]

HeartBeam (Nasdaq:BEAT) announced today that it submitted a 510(k) application to the FDA for its AIMIGo […]

  Reporting of medical device shortages to the FDA is no longer mandatory with last […]

Abbott has announced that the US Food and Drug Administration (FDA) has approved expanded magnetic […]

The FDA’s new draft guidance on Decentralized Clinical Trials (DCTs) is a landmark moment for […]

Sibel Health, a spin-out of Northwestern University, announced it received a new FDA 510(k) clearance […]

Vicarious Surgical is on track to bring the submission of its surgical robotic system to […]

Dive Brief: Samsung has received clearance from the U.S. Food and Drug Administration for an […]

Dive Brief: The head of the Food and Drug Administration has warned the U.S. needs […]

Cognixion announced today that it received FDA breakthrough device designation for its flagship brain-computer interface […]

Researchers at the Feinstein Institutes for Medical Research (Manhasset, USA) have received a US$3.4 million grant from Wellcome to […]

UK-based Ultromics announced it received FDA Breakthrough Device Designation for an AI tool that aims […]

Dive Brief: Dive Insight: Lawmakers have been trying to pass LDT legislation for years. An […]

Biotronik has announced US Food and Drug Administration (FDA) approval for Prospera—a new spinal cord […]

Biocoat Inc. is making some substantial noise in the coating market. The Horsham, PA-based company […]

Neuromod Devices announced today that it closed a $33.2 million (€30 million) financing round to support […]

NEWS RELEASE: Nelson Labs Receives ASCA (Accreditation Scheme for Conformity Assessment) Accreditation from the U.S. […]

Restor3d received FDA 510(k) clearance for its Axiom patient-specific resection (PSR) system for use with […]

Medtech company Masimo announced it had received FDA De Novo clearance for Opioid Halo, the […]

Opioid overdose can be quickly countered by a nasal spray administration of naloxone, a drug […]

Dive Brief: The U.S. Food and Drug Administration has qualified a tool made by NEVA […]

  [Image courtesy of the FDA] The FDA is responding to an ever-growing list of […]

Dive Brief: Medtech companies will be able to more easily update devices with an artificial […]

Dive Brief: Surmodics, which is partnering with Abbott to develop a drug-coated balloon treatment for […]

Better Therapeutics (Nasdaq:BTTX) shares ticked up on fourth-quarter results and projections for its flagship product in […]

Synaptive Medical has announced US Food and Drug Administration (FDA) registration of its next-generation robotic […]

When it comes to medicine, catering to convenience and patient preference can have life-changing results. […]

Woven Orthopedic Technologies announced recently that the FDA granted 510(k) clearance for its Ogmend implant enhancement […]

Athersys has announced planned amendments to its MASTERS-2 clinical trial protocol following a Type B […]

Brainomix has today announced that its 360 e-ASPECTS tool for stroke has received US Food […]

Vivasure Medical announced today that it received FDA investigational device exemption (IDE) to advance a clinical […]

Dive Brief: Baxter International issued an urgent medical device correction notice for its Life2000 Ventilation […]

Carthera, which develops the Sonocloud—an ultrasound-based medical device used to treat a wide range of […]

Respiree, a med tech spinoff of Singapore’s Agency for Science, Technology and Research, has obtained […]

Neuromod Devices announced that the FDA granted de novo approval to its Lenire neuromodulation device for […]

The FDA cleared a new gastric calibration tube last week, announcing it as the first authorization of […]