Roundup: CardieX files 510(k) for dual blood pressure, arterial health monitor and more briefs
CardieX files 510(k) for dual blood pressure, arterial health monitor Australia-listed health tech firm CardieX […]
CardieX files 510(k) for dual blood pressure, arterial health monitor Australia-listed health tech firm CardieX […]
Varian announced today that it received FDA investigational device exemption IDE to advance its Flash clinical […]
Dive Brief: The Food and Drug Administration is seeking feedback on draft guidance intended to help manufacturers […]
The US Food and Drug Administration has finalized guidance on the regulation of software as […]
3Spine has announced US Food and Drug Administration (FDA) investigational device exemption (IDE) approval for […]
SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyper […]
Carthera announced today that its Sonocloud-9 system has been listed as a Breakthrough Device by […]
One of the most common forms of eye strain now comes from looking at the […]
Aura Oslapas says that being able to show her neurologist how her motor symptoms were […]
Aurora Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) […]
Zavation Medical announced today that it received FDA 510(k) clearance for its eZspand lateral expandable lumbar […]
Dive Brief: The House of Representatives passed legislation late Wednesday to reauthorize the Food and […]
The US Food and Drug Administration announced that it has withdrawn its temporary policies related […]
Dive Brief: The Food and Drug Administration’s Center for Devices and Radiological Health plans to […]
Though it affects only somewhere between 0.1% and 1% of the world’s population, pulmonary hypertension […]
MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR […]
As a principal investigator for the pivotal VNS-REHAB study, which supported the first US Food […]
Machine Learning has been an ongoing focus of FDA activity for some time. The first […]
The serious and life-threatening infections experienced by those born with the rare immune disorder leukocyte […]
Injection delivery system developer ApiJect announced today that it completed a private investment round worth […]
Ananda Scientific announced that it received an FDA investigational new drug (IND) approval for a […]
Flow Neuroscience, which claims to be the creator of Europe’s first medically approved brain stimulation […]
Cepheid has announced that its Xpert Xpress CoV-2 plus test has received emergency use authorisation (EUA) from […]
The US Food and Drug Administration (FDA) has issued draft guidance describing the agency’s participation […]
Synchron has announced the enrollment of the first patient in the US COMMAND clinical trial […]
The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used […]
Results from a two-level multicentre FDA investigational device exemption (IDE) study have shown superior outcomes […]
The FDA has proposed an order requiring Philips (NYSE:PHG) to submit a plan for its recalled respiratory […]
Empirical Spine recently submitted premarket approval (PMA) Module II in the US Food and Drug […]
A handheld device that treats migraine attacks with puffs of air in a patient’s ears […]
Medtronic (NYSE:MDT) is investigating a new problem with its HeartWare Ventricular Assist Device (HVAD) nearly one […]
The medical imaging device group, MITA, has voiced support for legislation that calls for clarity […]
Axsome Therapeutics is bracing for another setback as the FDA is now expected to nix […]
On April 8, 2022, the US Food and Drug Administration published a new draft guidance, […]
NuVasive (Nasdaq:NUVA) today announced data from an FDA investigational device exemption study supporting its Simplify cervical […]
Royal Philips (NYSE:PHG) announced today that the first patients were successfully treated with its CavaClear IVC […]
Virtual Incision announced today that it received an FDA investigational device exemption (IDE) supplement for its […]
After researchers began looking into ways to detect COVID-19 in breath samples, InspectIR Systems’ test will […]
Medical device product recalls were down 14.3% in the federal government’s fiscal year 2021, according […]
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.