Topic: FDA

Today, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software […]

FDA has granted breakthrough status to two medical devices aimed at Alzheimer’s disease patients in […]

PerkinElmer is targeting asymptomatic people in its latest testing offering for COVID-19 testing. The Waltham, […]

FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a […]

The FDA today released its first plan to regulate artificial intelligence/machine learning (AI/ML)-based Software as […]

Advaite announced today that it received FDA emergency use authorization for its RapCov point-of-care COVID-19 antibody […]

The FDA today released its first plan to regulate artificial intelligence/machine learning (AI/ML)-based Software as […]

The FDA has released final guidance for a new, voluntary review process that would streamline […]

The promise of a digital revolution in healthcare has been described as “just a few […]

Cardiac imaging technology developer Genetesis announced today that its flagship product received FDA breakthrough device designation. Mason, […]

ReCor Medical this week announced that its Paradise Ultrasound Renal Denervation System won FDA breakthrough device […]

Ensemble Orthopedics recently announced said it received FDA 510(k) clearance for its Ensemble CMC Implant. […]

Ischemic stroke treatment developer BrainsGate announced today that it secured a $14 million investment to fund future […]

Vectorious Medical Technologies today announced that the FDA has granted breakthrough device designation for the company’s […]

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced that they will submit a request today with […]

Penumbra (NYSE:PEN) announced today that the FDA has granted expanded clearance for its Indigo aspiration catheter […]

Eli Lilly (NYSE:LLY) and Ypsomed (SWX:YPSN) are teaming up to create an automated insulin delivery […]

Lucira’s molecular testing kit allows individuals to collect their own nasal sample and insert it […]

Tissium today said it received FDA investigational device exemption for its vascular sealant. The vascular […]

Baxter (NYSE:BAX) Canada announced today that it received Health Canada authorization for its Novum IQ infusion […]

After seeing its overall revenues slip last quarter, Hologic’s COVID-19 testing sales have continued to […]

The FDA has released a list of essential medical devices, medicines and “medical countermeasures” that […]

Dive Brief: Computer vision-focused healthcare company Gauss Surgical on Monday announced its clinical study results for […]

Dive Brief: An FDA advisory committee was overwhelmingly not convinced of the effectiveness of a […]

Dive Brief: FDA’s circulatory system devices panel Tuesday is examining a premarket approval application for […]

Dive Brief: Exact Sciences announced Tuesday it plans to buy fellow liquid biopsy developer Thrive […]

Dive Brief: FDA officials and the head of global software standards at Philips have warned […]

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 […]