Topic: FDA

AppliedVR announced that it received FDA breakthrough device designation for its fibromyalgia and lower back […]

Virtual reality company AppliedVR has landed an FDA Breakthrough Device designation for its technology designed […]

Livmor has won a nod from FDA for a physician-prescribed wearable that continuously monitors for […]

From time to time, medtech analysts will call out companies in the private sector that […]

Abiomed (NSDQ:ABMD) today announced interim results of a study that found high-risk patients had better outcomes […]

CartiHeal announced that it received FDA breakthrough device designation for its Agili-C implant for treating […]

FDA has awarded SetPoint Medical breakthrough device designation for a bioelectronic technology that stimulates the […]

A new indication could help extend the use of Senseonics’s continuous glucose monitor (CGM) system. […]

Dive Brief: FDA on Monday finalized labeling guidance for breast implant manufacturers, including a boxed warning informing […]

The FDA announced this week that it will launch a “Digital Health Center of Excellence” […]

Spineology this week announced it received an FDA de novo grant for its minimally invasive […]

The FDA has released proposed regulations to make clear that off-label use of a device […]

Medtronic is keeping the product fires warm with a new breakthrough device designation aimed at […]

Dexcom is launching a registry to track user outcomes in U.S. hospitals where its and […]

Dive Brief: BD is investigating reports of false positive coronavirus test results in nursing homes […]

Dive Brief: The Medical Device Innovation Consortium (MDIC), a public-private partnership with a focus on […]

Olympus announced today that it has entered into an exclusive agreement with UK-based Alesi Surgical […]

Dive Brief: Medtronic on Wednesday simultaneously announced FDA breakthrough device designation and kickoff of an early […]

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under […]

SurGenTec announced today that it received FDA 510(k) clearance for its proprietary OsteoFlo NanoPutty quadphasic synthetic […]

VALENCIA, Calif., Aug. 24, 2020 /PRNewswire/ — Valencia Technologies Corporation (“Valencia“), a private medical device company, today announced […]

  Under intense criticism for his statement that convalescent plasma donated by former coronavirus patients […]

Dive Brief: Scott Gottlieb, the Trump administration’s former FDA commissioner, took to Twitter on Saturday […]

Becton Dickinson (NYSE:BDX) today offered an update confirming three separate issues related to the recall of […]

Endospan has received investigational device exemption (IDE) approval from the US Food and Drug Administration […]

Dive Brief: FDA on Friday proposed reclassifying noninvasive bone growth stimulators from Class III into […]

Dive Brief: FDA over the weekend granted emergency use authorization to a COVID-19 saliva test […]

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 […]