Category: Medical Equipment

Medical Equipment

FDA Grants Marketing Authorization for System that Monitors Opioid Use Health Risks

The FDA granted marketing authorization for a device that recognizes when someone experiences opioid-induced respiratory depression.

Medical Equipment

Asensus Surgical Nabs FDA Clearance For Senhance Pediatric Surgery Solution

Asensus Surgical received FDA 510(k) clearance for an expanded indication to treat pediatric patients with the Senhance Surgical System.

Medical Equipment

Service Intelligence: Relief for Field-Service Pain Points

Leaders of medical device field-service teams are paying attention to ways they can help professionals build skills for consistent performance. Here is how.

Medical Equipment

FDA Grants Marketing Authorization for System that Monitors Opioid Use Health Risks

The FDA granted marketing authorization for a device that recognizes when someone experiences opioid-induced respiratory depression.

Testing & Calibration

MediPines Expands Distribution of its Pulmonary Gas Exchange Tech

MediPines announced that its FDA-cleared, non-invasive pulmonary gas exchange analyzer, the MediPines AGM100, is now available in Canada.

Imaging Equipment

GE HealthCare Recalls Nuclear Medicine Systems

GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after identifying an issue with two of its mechanisms.

Patient Care Equipment

Getinge Subsidiary’s Intra-Aortic Balloon Pumps Get Class I Recall

Getinge subsidiary Datascope is recalling two types of Intra-Aortic Balloon Pumps due to the possibility of unexpected device shutdown.

Software

How Zero-Trust Solutions Can Improve Healthcare Asset Security

A new industry blueprint was published to help healthcare IT leaders better understand zero-trust principles and examine vendor architectures.

Testing & Calibration

ECRI Workflow Solution Improves Healthcare Product, Standardization Decisions

ECRI released an enhanced technology solution designed to improve new healthcare product and standardization decisions.

Imaging Equipment

Konica Minolta to Unveil New Point-of-Care Ultrasound System

Konica Minolta Healthcare Americas Inc. announces that it will introduce its compact, point-of-care ultrasound system, SonImage MX1 Platinum, at the 2022 Annual Meeting of the Radiological Society of North America, which takes place from November 27-December 1 in Chicago.

Medical Equipment

Parachute Health Achieves HITRUST Certification for Healthcare Information Security

Parachute Health's durable medical equipment ePrescribing Platform has earned Certified status for information security by HITRUST.

Patient Care Equipment

Reworked Philips Ventilators Get Class I Recall for Potential Foam Debris Issues

Philips Respironics recalled certain reworked ventilators for issues related to foam adhesion failure and foam debris.

Software

Medisafe Expands Business Solutions with New Software as a Medical Device

Medisafe, a digital therapeutics company specializing in medication engagement, has unveiled its new Software as a Medical Device technology.

Medical Equipment

Spacelabs Healthcare to Pay $2.5M to Settle False Claims Act Allegations for Patient Monitoring Equipment

Spacelabs Healthcare agreed to pay $2.5 million to resolve allegations that it overcharged the U.S. for patient monitoring equipment.