Roche CustomBiotech

By webasia

09 Dec 22

Devices

US FDA approves Roche’s two Elecsys CSF assays to detect Alzheimer’s disease

By NS Medical Staff Writer

09 Dec 22

The company designed the two Elecsys CSF assays to measure the concentrations of beta‑Amyloid and Phospho‑Tau proteins in…

DevicesDiagnostic Devices

Thinklabs Medical and eMurmur partner for new remote auscultation system

By NS Medical Staff Writer

09 Dec 22

The pocket-sized digital stethoscope and auscultation software is intended for remote monitoring of heart and lung sounds

DevicesDiagnostic Devices

FDA clears Dexcom G7 CGM system for all types of diabetes

By NS Medical Staff Writer

09 Dec 22

Dexcom G7 CGM is said to easily integrate with connected CGM ecosystems like Apple Watch, Garmin, and other…

DevicesDiabetes Care

CORD Files for Premarket Approval with the U.S. Food and Drug Administration for the SC9 Intraocular Lens for Cataract Surgery

By NS Medical Staff Writer

09 Dec 22

SC9 Incorporates 21 Patented Features Designed to Position the Lens for Superior Intermediate Vision

DevicesOphthalmic

BIOCORP secures FDA 510(k) approval for Mallya smart device

By NS Medical Staff Writer

08 Dec 22

Mallya is a smart sensor that converts insulin pen injectors into connected medical devices, to automatically record important…

DevicesDiabetes Care

FDA authorises Thermo Fisher’s SeCore HLA typing test as CDx for Kimmtrak

By NS Medical Staff Writer

08 Dec 22

The SeCore CDx HLA Sequencing System is claimed by Thermo Fisher Scientific as the first HLA typing test…

DevicesDiagnostic Devices

HeartBeam, Evolve Manufacturing team up to develop AIMIGo 3D VECG device

By NS Medical Staff Writer

08 Dec 22

Under the agreement, HeartBeam will make use of the manufacturing and packaging expertise of Evolve Manufacturing to commercialise…

DevicesCardiovascular

Shineco, Inc Subsidiary, Granted USPTO Patent and FDA Marketing Approval for Its In-situ Fecal Specimen Sampling Device

By NS Medical Staff Writer

08 Dec 22

This product provides a massager-like fingertip swab, a collection tube and a lid with unidirectional sampling inlet

DevicesApprovalsDiagnostic Devices

Endologix Receives FDA Approval of PMA Supplement for AFX2 System

By NS Medical Staff Writer

08 Dec 22

Endologix is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for…

DevicesCardiovascular