Tag: FDA

shutdown

US government shutdown disrupting FDA work

The US government shutdown means the country’s Food and Drug Administration (FDA) cannot accept new user fees, which means the agency cannot accept new...

US FDA plan shakeup of its 510(k) clearance programme

The US FDA has announced plans to modernise its 510(k) clearance programme for approving medical devices for the US market. Data show that about...

US FDA issues draft guidances for recommended premarket testing and labelling...

The US Food and Drug Administration (FDA) released the following two draft guidance documents: These guidance documents provide industry and FDA staff with recommendations on...

FDA classifies HeartWare HVAD systems unexpected power source switching as Class...

The United States Food and Drug Administration (FDA) has classified Medtronic recent voluntary urgent field action related to the HeartWare HVAD System unexpected power...

Battery performance alert and cybersecurity firmware updates for certain Abbott implantable...

The US FDA has approved a firmware update that is now available and is intended as a corrective action (recall), to reduce the risk...

Medtronic: class I recall- manufacturing error preventing electrical shock delivery

Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) due to a defect in the manufacturing process.  This defect...

Clarithromycin (Biaxin): potential increased risk of heart problems or death in...

The FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart...

New FDA approvals for Abbott’s MRI-ready devices

Abbott has announced the US Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labelling for the Quadra Assura MP cardiac resynchronisation therapy...

Medtronic HeartWare HVAD approved for destination therapy

The US Food and Drug Administration (FDA) has approved Medtronic’s HeartWare HVAD system as a destination therapy for patients with advanced heart failure who...

US FDA bans powdered gloves

The US Food and Drug Administration (FDA) has issued a final rule to ban powdered surgical gloves, patient examination gloves and the absorbable powder...

NICE collaborates with US FDA on Payer Communication Taskforce

The UK’s National Institute for Health and Care Excellence (NICE) has announced its participation in the US Food and Drug Administration (FDA)’s Payer Communication...

Fewer cardiovascular drugs being studied in clinical trials

The number of cardiovascular drugs in the research pipeline has declined across all phases of development in the last 20 years—even as cardiovascular disease...

US FDA approves Boston Scientific Emblem MRI S-ICD system

Boston Scientific has received US Food and Drug Administration (FDA) approval for the Emblem MRI subcutaneous implantable defibrillator (S-ICD) system, as well as magnetic...

US FDA clears expanded paediatric indication for Itamar Medical WatchPAT device

Itamar Medical has received US Food and Drug Administration (FDA) clearance to expand the medical indication of WatchPAT for sleep apnoea diagnosis. WatchPAT is...