Category: FDA Updates

FDA Updates

LivaNova Recalls Blood Pump Device for Risk of Unintentional Extended Pump Stop

LivaNova is recalling the LifeSPARC Controller due to a software update being available to address a previous software malfunction.

Getinge Subsidiary Recalls Intra-Aortic Balloon Pumps Due to Compromised Materials
RenalGuard Therapy Gets Breakthrough Device Designation for Prevention of Cardiac Surgery Associated AKI
Opticyte’s Patient Monitor for Organ Failure Earns Breakthrough Device Designation
Gaps in Recalls of Home Medical Devices Top ECRI’s Hazards List
FDA Issues Warning Letters to Endoscope Manufacturer Olympus
Rethinking 510(k): Studies Show Risk of Using Recalled Devices as Predicates for FDA Clearance

FDA Updates

Lydus Medical Announces FDA Clearance of Microvascular Anastomosis Aid Device

Lydus Medical received FDA clearance 510(k) for a microvascular anastomosis suture deployment system for standardized omni-vessel anastomoses.

FDA Updates

FDA Issues Guidance on Voluntary Malfunction Summary Reporting Program for Device Manufacturers

The U.S. FDA has issued a draft guidance to help medical device manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting Program.

Clearances

XACT Robotics System Nabs FDA Clearance

XACT Robotics, which offers a robotic system for interventional procedures, announces that the U.S. FDA has cleared its ACE Xtend Remote Control Unit, allowing users to robotically insert and steer the XACT ACE Robotic System remotely from the control room.

Recalls

Frustrations Grow Over Company’s Response to CPAP Recalls

Philips has experienced thousands of complaints, lawsuits, criminal investigations, and a potential DOJ settlement related to CPAP recalls.

Labeling

Ready for the UDI Enforcement Deadline?

If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.

Draft Guidances

FDA Issues Draft Guidance on Remanufacturing, Seeks Feedback on Cybersecurity Servicing of Medical Devices

The U.S. FDA is now accepting comments from the public on the draft guidance, “Remanufacturing of Medical Devices,” and on a discussion paper on cybersecurity servicing of devices.