MedTech News

Insulet wins CE mark for integration of insulin pump with Abbott CGM
The clearance positions Insulet to sell the integrated Type 1 diabetes product in Europe beginning in the first half of the year.

Sensus Healthcare Issued U.S. Patent for SRT-100 Vision® System (IG-SRT) Capabilities
BOCA RATON, Fla., Feb. 08, 2024 (GLOBE NEWSWIRE) — Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for oncological and non-oncological conditions, announces that the U.S. Patent and Trademark Office (USPTO) has issued Patent No. 11,894,123 B2, titled “Radiotherapy Mobile and Wireless Device Workflow Management System.”

FDA clears 5008X hemodialysis system from Fresenius Medical Care
Fresenius Medical Care announced today that it received FDA clearance for its 5008X hemodialysis system.

Boston Scientific’s spinal cord stimulators approved for non-surgical back pain
FDA backing for the Wavewriter SCS systems allows the company to challenge Abbott and Nevro.

Using cancer’s strength to fight against it
New technique made human T cells 100 times more potent at killing cancer cells

Tyber Medical Anatomical Plating System Cleared For Canada
BETHLEHEM, Pa., Feb. 6, 2024 /PRNewswire/ — Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, received clearance for the anatomical plating system in Canada. The comprehensive portfolio previously received FDA 510(k) in the US and has now been cleared through Health Canada.

FDA Clears Groundbreaking Corplex P™: The First Human Umbilical Cord-Derived Medical Device
ROSWELL, Ga., Feb. 6, 2024 /PRNewswire/ — StimLabs® announces FDA 510(k) clearance of Corplex P, the pioneering human umbilical cord-derived medical device. This first-of-its-kind clearance marks a significant milestone for the wound care industry and highlights StimLabs’ position at its forefront.

FDA expands approval for Boston Scientific spinal cord stim to include chronic back pain without prior back surgery
Boston Scientific (NYSE: BSX)+
announced today that the FDA approved an expanded indication for its WaveWriter spinal cord stimulation (SCS) systems.