Eko wins FDA nod for AI to detect sign of heart failure using stethoscope
April 4, 2024
The clearance adds to the list of devices the FDA has authorized this year with AI algorithms to detect health conditions.
The clearance adds to the list of devices the FDA has authorized this year with AI algorithms to detect health conditions.
Biotronik this week announced it received FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold (BTK RMS).
Axonics (Nasdaq:AXNX) announced today that it received CE mark approval for its R20 rechargeable sacral neuromodulation (SNM) system.
The FDA’s decision allows people who don’t take insulin, including those who don’t have diabetes, to use the devices without a prescription.
The FDA created special controls that provide a path to market for other developers of over-the-counter devices.
SAN FRANCISCO, Feb. 14, 2024 (GLOBE NEWSWIRE) — ZKR Orthopedics, Inc., a clinical stage medical device company, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial. The approved trial will evaluate the Company’s LIFT implant to treat later stage patellofemoral cartilage degeneration in adult patients.
FDA backing for the Wavewriter SCS systems allows the company to challenge Abbott and Nevro.
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.
A Prospective, Randomized, Multicenter Study Assessing the Safety and Efficacy of the ReCET™ System in Adult Patients with Type 2 Diabetes
Element Science announced that it received CE mark approval for its novel patch-wearable cardioverter defibrillator (P-WCD).