SpaceLabs’ Arkon anesthesia system recalled again

The FDA  has slapped SpaceLabs Healthcare with a Class 1 recall of its Arkon anesthesia delivery system for going into a “failed state” on numerous occasions since 2013. The recall covers 253 units. No injuries or deaths were reported. During the failed state, the mechanical ventilation function stops working while the machine is in use

Report slams European Union’s high-risk medical device approvals rate

A health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the December 2017 issue of Value in Health by ISPOR. The authors looked at 1,376 health technology assessment (HTA) reports filed between 2010 and 2015.

FDA extends UDI deadline for Class I devices

By Stewart Eisenhart, Emergo Group US Food and Drug Administration medical device regulators have extended Unique Device Identification (UDI) labeling and related compliance deadlines for lower-risk devices to late 2022 in order to fully standardize and optimize UDI data already collected on high-risk devices. Get the full story here at the Emergo Group’s blog. The

FDA extends UDI compliance date for low risk devices

Labelers of class I and unclassified devices recently got a reprieve when FDA announced an extension of the compliance date for unique device identification (UDI). Makers of devices such as manual surgical instruments and mechanical wheelchairs will have 2 extra years to get these devices submitted to the Global unique device identification database (GUDID), FDA announced last

How Atlas Vac Machine plans to gain on UDI

Atlas Vac Machine, a maker of medical tray and blister sealers, has added new features to its equipment to better aid medical device companies trying to keep up with FDA’s Unique Device Identification rules. Over the past year, the Cincinnati-based company has had its machines providing data logging of operator IDs and passwords, sign-ins, PW

What are the 10 keys to the U.S. pathway to medical device approval?

Debra Grodt/Director of Regulatory Affairs/Medical Device and Diagnostics Novella Clinical What is a regulatory assessment? A regulatory assessment is a comprehensive review of Food & Drug Administration (FDA) regulations and similarly marketed devices to establish a framework to design a safe and effective product. Assessments include: 1) a detailed rationale for product classification; 2) applicable

Dutch Mellon Medical unveils major innovation in surgical suture technology: Single-handed suturing using the Switch

Mellon Medical is unveiling a patented ground-breaking global innovation in suturing technology. The company has developed a platform technology for suturing with a single hand. The Switch, a disposable precision-suturing instrument, enables surgeons to suture tubular and layered structures about twice as fast as the conventional technique. The technology is expected to reduce the risk

Design for people, not medical conditions: Motivo reimagines the walker

Motivo Tour is like no walker you’ve ever seen. It is not a cage of connected metal tubes. Instead, it is a lightweight unibody design that comes with customizable paneling, polychromatic colors and some important design features that make life easier for both users and caregivers. “No one really seemed interested in redesigning the walker,”

Medical Murray adds clean room space in two facilities

Medical Murray, a device development and contract manufacturing company with ISO 13485 certification and FDA registration, has expanded clean room capabilities in their Illinois manufacturing facility and North Carolina location. The additions come less than a year after Medical Murray purchased their Lake Zurich, Ill., 44,000 square-foot manufacturing facility, and built a larger 10,000 square-foot

Tips for meeting the deadline: One month until U.S. FDA UDI compliance date for Class II devices

The compliance date for device labelers to place Unique Device Identifiers (UDIs) on their Class II devices is approaching quickly. Under the U.S. Food and Drug Administration (FDA) final rule, Class II devices must be labeled with UDIs starting September 24, 2016. FDA consulting firm Registrar Corp is providing tips to help labelers of Class

ResolutionMD is registered for web and mobile diagnosis in Costa Rica

Calgary Scientific, a company known for creating innovative technology for the medical industry and beyond, announced that ResolutionMD medical imaging software is registered by the Ministry of Health in Costa Rica for diagnosis using both web and mobile devices. The Costa Rican Ministry of Health regulates the healthcare industry and acts as the regulatory agency

Injection molding and plastics for medical devices

Medical device manufacturers can easily avoid expense by choosing an injection molder experience in the medical industry. The injection molder will have the facility, equipment, trained personnel for this type of manufacturing and relationships with vendors to provide quality materials and resources. Included in this are the specialized skills like design for manufacturability, mold building

AlloSource distributes first bioengineered blood vessels for Humacyte Phase III clinical trial

AlloSource, one of the nation’s largest providers of cartilage, cellular, bone, skin and soft-tissue allografts for use in surgical procedures and wound care to advance patient healing, announced the distribution of investigational bioengineered blood vessels for Humacyte’s Phase III clinical trials. The first shipment of vessels will be used in the upcoming Phase III clinical

Proven Process chosen by Modus Health to manufacture class II medical device

Proven Process Medical Devices Inc., a global leader in the design, development, validation, and manufacture of Class II and Class III medical devices, announced today it has been selected to manufacture StepWatch, a Class II, scientifically validated, highly-accurate wearable device for Modus Health LLC of Boston, MA. Modus Health is a health technology company delivering

Ten steps to comply with FDA UDI requirements

The Sept. 24, 2016 Unique Device Identifier (UDI) compliance date for class II medical devices is quickly approaching. To assist device labelers through the UDI compliance process, Registrar Corp compiled a list of the top ten things to do to comply with the U.S. Food and Drug Administration’s (FDA) UDI requirements. 1. Determine the UDI