Category: FDA Updates

FDA Updates

FDA Tightens Cybersecurity Regulations for Medical Devices

The FDA now mandates that medical device manufacturers include a SBOM for cybersecurity compliance under FD&C Act.

FDA Updates

CellFX Electrode System Earns FDA Approval

Pulse Biosciences announced that the FDA granted 510(k) clearance for its CellFX nsPFA Percutaneous Electrode System.

FDA Updates

Philips Recalls BrightView Imaging Systems

Philips has recalled its BrightView SPECT imaging systems for a potential component failure that would cause parts to fall on the patient.

Clearances

Nanowear SimpleSense Wearable Nabs FDA Clearance

Nanowear has received U.S. FDA 510(K) clearance for its AI-enabled Software-as-a-Medical Device called SimpleSense, which includes a non-invasive continuous blood pressure monitor for clinical diagnostic management of hypertension.

Recalls

ResMed Recalls CPAP Masks for Possible Magnetic Interference

ResMed Ltd is recalling all its CPAP masks with magnets due to possible magnetic interference with certain medical devices.

Labeling

Admetsys Blood Diagnostic System Made Breakthrough Device

Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.

Draft Guidances

FDA Establishes Digital Health Advisory Committee

The FDA is establishing a Digital Health Advisory Committee in 2024, comprising experts from various fields, to advise on the safe and effective regulation of digital health technologies like AI, virtual reality, and wearables, aiming to promote innovation while safeguarding public health.