Company Product Description Indication Status
Aerus Holdings LLC, of Dallas Aerus Medical Guardian with Activepure Technology Free-standing, portable air purifier Eliminates airborne contaminants in health care settings Received U.S. FDA clearance
Ancora Heart Inc., of Santa Clara, Calif. Accucinch Ventricular restoration system Provides support to the left ventricular wall in patients with heart failure (HF) and reduced ejection fraction The U.S. FDA approved its investigational device exemption application for the Corcinch-HF pivotal study
Corelink LLC, of St. Louis F3D-C2 Stand-alone cervical spine system; 3D-printed spacer with 2 bone screw anchors For anterior cervical discectomy and fusion procedures Received 510(k) clearance from the U.S. FDA
Endra Life Sciences Inc., of Ann Arbor, Mich. Thermo acoustic enhanced ultrasound (TAEUS) Fatty liver imaging probe For the assessment and monitoring of nonalcoholic fatty liver disease and inflammation Submitted a 510(k) application to the U.S. FDA
Illuminoss Medical Inc., of East Providence, R.I. Photodynamic bone stabilization system Uses a light-curable polymer contained within an expandable balloon For fracture repair and stabilization through a patient-specific intramedullary implant Received expanded U.S. FDA 510(k) clearance for treatment of fractures of the pelvis, clavicle, and the small bones of the hands and feet: metacarpals, metatarsals, and phalange; previously cleared for the humerus, radius, and ulna
Kardium Inc., of Burnaby, British Columbia Globe mapping and ablation system Spherical catheter that has 122 electrodes Treatment of atrial fibrillation Received the CE mark
Livsmed Inc., of San Diego Artisential Bipolar Maryland Dissectors Laparoscopic instruments Electrosurgical cutting and coagulation Received U.S. FDA clearance
Qure.ai Technologies Pvt. Ltd., of Mumbai qER Artificial intelligence-based CT scan product Used to triage radiology scans with intracranial bleeds, mass effect, midline shift and cranial fractures Received 510(k) clearance from the U.S. FDA
Seegene Inc., of Seoul, South Korea Allplex 2019-nCoV assay Real-time PCR assay; identifies E, RdRP and N genes in a single reaction tube Detects SARS-CoV-2 Obtained provisional authorization from the Health Sciences Authority in Singapore

Notes

For more information about individual companies and/or products, see Cortellis.

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