Vivos Therapeutics specializes in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders (including all severities of obstructive sleep apnea (OSA) in adults).
Medical Microinstruments said the system could increase the number of physicians who can perform complicated microsurgical procedures.
New Indication for Treatment of Pulmonary Embolism Enhances Device Utility in Critical Medical Scenarios
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.