Vivos Therapeutics, Inc. says its removable CARE (Complete Airway Repositioning and/or Expansion) oral appliance has been granted U. S. FDA … continue reading “Severe Sleep Apnea “Game-Changing” FDA Clearance”
Medtronic plc says the US FDA has approved the Symplicity Spyral ™ renal denervation (RDN) system as an adjunct to … continue reading “Spyral ™ Gains FDA Approval”
Forty UK HealthTech Innovators Seek Support Stateside The UK’s health technology industry body, the Association of British HealthTech Industries (ABHI) … continue reading “ABHI Launches US Accelerator 2022 Programme”
ENT technology company Intersect ENT®, Inc., has announced that the U.S. Centers for Medicare and Medicaid Services (CMS) have published … continue reading “SINUVA® Sinus Implant Reimbursement Picture Clears”
Medtronic plc has announced the U.S. commercial launch of the Carpediem™ Cardio-Renal Pediatric Dialysis Emergency Machine, the first and only … continue reading “Carpediem™ First Cardio-Renal Pediatric Dialysis Launch”
The U.S. FDA has granted Breakthrough Device Designation to Cala Trio™ for the treatment of action tremors in the hands … continue reading “FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson’s Disease”
NiTiNOL-based DynaNail products approved for use with new ICD-10-PCS code. This new classification will enable healthcare providers and payers to … continue reading “DynaNail® Becomes First Sustained Compression Internal Fixation Device to Gain CMS Code”
The U.S. FDA has granted Emergency Use Authorization to Ortho Clinical Diagnostics’ total antibody assay for COVID-19 – the VITROS® … continue reading “FDA Emergency Use Authorization for Ortho’s COVID-19 Total Antibody Test”
The Association of British HealthTech Industries (ABHI) has taken another important step in supporting UK HealthTech companies do business in … continue reading “Next Phase for ABHI US Accelerator as Programme Expands”
JointPoint’s hip navigation system allows for digital templating and precise analysis of implant selection and positioning
FMX314 is the world’s first single-port surgery solution that is compatible with a standard 15mm trocar for MIS abdominal laparoscopic surgery.
Adherium establishes North American operation and appoints Senior Vice President of Business Development to lead market expansion
An implantable drug delivery pump forms the basis of a new company, Medallion Therapeutics, Inc., which has sprung from the Alfred Mann Foundation (AMF) for Scientific Research.
Medical device integration solutions company Capsule Tech, Inc., is using the HIMSS event in Florida this week to announce the introduction of its SmartLinx™ Medical Device Information System.
Biomet, Inc. has reached a settlement amounting to $56 million in Multi-District Litigation (MDL) 2391 relating to its M2A Magnum Hip Implant Products.
Law firm Bernstein Liebhard LLP has issued a press release that brings us up to date, pointing in particular to a piece of research that suggests 30% of robotic surgery complications using Intuitive’s da Vinci system, as reported on the FDA’s MAUDE database, were either a result of operator error or technical failure of the robotic system itself.