Latest medtech regulatory news

Selution SLR receives second FDA IDE approval

MedAlliance’s sirolimus-eluting balloon, received conditional U.S. FDA Investigational Device Exemption (IDE) approval to initiate its clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA).

This comes only a few months after the company received IDE approval for Selution SLR in the treatment of below-the-knee (BTK) indications (May 2022).

“This is a significant milestone for MedAlliance: we are the first non-paclitaxel drug coated balloon to receive IDE approval, and now the first to have two applications approved. This is the culmination of a multi-year R&D program to provide the comprehensive non-clinical data required to satisfy the very high standards expected by the U.S. FDA,” says Jeffrey B. Jump, MedAlliance chairman and CEO.

Selution SLR was awarded CE Mark approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020. The FDA awarded Selution SLR with four breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee; and AV-Fistula indications.

Standard evaluates stumbling-related fall risk

An ASTM Int’l standard (F3578) will help evaluate the effect of exoskeletons on fall risk due to stumbling. The new standard is a product of ASTM’s Exo Technology Center of Excellence’s Research to Standards efforts.

“Exoskeletons are wearable devices to help reduce disabilities, prevent musculoskeletal injuries, and improve well-being,” says ASTM member Karl Zelik. “We’ve developed this new test method to determine if an exoskeleton improves, impedes, or maintains a user’s ability to recover from a stumble, or avoid falling.”

Zelik, an associate professor at Vanderbilt University and chief scientist at HeroWear, says the standard will assess if a specific exoskeleton is beneficial or detrimental in the presence of stumble perturbations during walking that can occur in daily, real-world environments.

Zelik notes the new standard, developed by ASTM’s exoskeletons and exosuits committee (F48) can be used for occupational, medical, military, or recreational exoskeletons.

ISO 13485:2016 certification for MMS

MultiMedical Systems’ (MMS) Quality Management System has earned ISO 13485:2016 certification from Orion. The three-year certification verifies that MMS, which provides medical device sales, service, and repair, developed and implemented a quality management system that conforms to the international requirements for medical devices.

“This certification further strengthens our commitment to our customers and our company quality policy,” says Daren Kneeland, CEO of MMS. “As an organization, we strive to understand, meet, and exceed our customer’s needs and expectations by providing medical device service of the highest possible standards, quality, safety, and reliability.”

FreeStyle Libre 3 receives FDA clearance

The U.S. Food and Drug Administration (FDA) cleared Abbott’s next-generation FreeStyle Libre 3 system for use by people four years and older living with diabetes.

“The FreeStyle Libre 3 system is a direct result of listening to our customers – and giving them the innovation and sensing technology they’ve been looking for,” says Jared Watkin, senior vice president of Abbott’s diabetes care business. “It’s a game changer for the millions of people living with diabetes. They’ll be able to manage their health minute-by-minute with the world’s smallest and thinnest sensor and most accurate 14-day continuous glucose monitoring system.”

The FreeStyle Libre 3 system was cleared for use with the FreeStyle Libre 3 iOS and Android mobile apps, enabling users to view their glucose levels in real time, track their glucose history and trends, and set up optional alarms plus notifications to alert them of serious medical events like hypoglycemia.

The mobile app integrates with the FreeStyle Libre digital ecosystem, including LibreView and LibreLinkUp enabling caregivers and healthcare professionals to remotely monitor loved ones and patients as needed.