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”
USA
Carpediem™ First Cardio-Renal Pediatric Dialysis Launch
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”
FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson’s Disease
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”
DynaNail® Becomes First Sustained Compression Internal Fixation Device to Gain CMS Code
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”
FDA Emergency Use Authorization for Ortho’s COVID-19 Total Antibody Test
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”
Next Phase for ABHI US Accelerator as Programme Expands
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”
DePuy Synthes Partners for Exclusive Access to Proprietary Hip Replacement Software
JointPoint’s hip navigation system allows for digital templating and precise analysis of implant selection and positioning
U.S. First-In-Man Laparoscopic Cholecystectomy with Fortimedix Surgical’s Lowest Profile Single-Port Surgery Solution
FMX314 is the world’s first single-port surgery solution that is compatible with a standard 15mm trocar for MIS abdominal laparoscopic surgery.
Smartinhaler™ Company Sets Stall Out in U.S.
Adherium establishes North American operation and appoints Senior Vice President of Business Development to lead market expansion
New Drug Delivery Device Company, Medallion Therapeutics Emerges from Alfred Mann Foundation
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.
HIMSS Congress Sees Launch of SmartLinx™ Medical Device Information System
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.
Metal-on-Metal Hip Ends Up Costing Biomet $56 Million
Biomet, Inc. has reached a settlement amounting to $56 million in Multi-District Litigation (MDL) 2391 relating to its M2A Magnum Hip Implant Products.
Legalists Point to Surgical Robot Training and Technical Failings
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.
Ethicon Reality Checks into Collaboration with Megadyne®
Ethicon Endo-Surgery, Inc. and Megadyne®, Inc have both issued press releases, confirming that they have entered into a collaboration agreement. The deal will see customers offered a contracting solution that incorporates the two companies’ combined product offerings, increasing choice and access to a broad energy portfolio.
Johnson & Johnson Considering $3 Billion Settlement of DePuy Hip Implant Lawsuits
Johnson & Johnson is considering a settlement with injured hip implant patients that could total more than $3 billion. Sources close to the matter have told Bloomberg that the company is weighing their options in settling thousands of cases involving DePuy hip implants that have been linked to early failure rates and a host of serious complications.
Could “Pacemaker Tax” Provide the Wriggle Room to End Obamacare Deadlock?
It looks like the US medtech sales tax could be the straw that breaks the camel’s back, as concessions need to be made to get the budget approved. Whether a repeal would be enough to cajole republicans into accepting Obamacare is doubtful, but it just might be.