Middle District of North Carolina Grants Preliminary Injunction in Natera, Inc. v. NeoGenomics Laboratories, Inc.
(December 27, 2023) Natera Inc. succeeded in obtaining a preliminary injunction against NeoGenomics Laboratories, Inc.’s medical assay test. Natera’s ongoing federal lawsuit alleges that NeoGenomics’ product “RaDaR,” a tumor informed...
Boston Scientific to Acquire Axonics for $3.7 Billion
Boston Scientific Corporation (“Boston Scientific”) announced on January 8 that it has entered into a definitive agreement to acquire Axonics, Inc. (“Axonics”) for an equity value of approximately $3.7 billion. ...
CardioMech Raises $13 Million for Transcatheter Mitral Chordal Repair Technology
CardioMech AS (“CardioMech”) announced that the company successfully raised $13 Million in capital in addition to the $18.5 Million Series A financing in 2020 bringing total funding to $42 Million. CardioMech...
First At-Home Artificial Insemination Kit Receives FDA Clearance
Mosie Baby, a Texas-based fertility care company, has received clearance from the U.S. Food and Drug Administration for its over-the-counter intravaginal insemination kit. The kit was developed for those who...
FDA Clears ABK Biomedical’s Eye90 Microspheres for Hepatocellular Carcinoma Treatment
ABK Biomedical successfully secured Breakthrough Device Designation from the FDA on December 5, 2023, for its Eye90 microspheres device, which is indicated for the treatment of unresectable Hepatocellular Carcinoma (HCC)....
Recent Developments in Medical Casts
On October 5, 2023, the World Intellectual Property Organization published Cast21’s PCT application related to its alternative cast device – a 3D-printed exoskeleton created from a medical-grade resin. Cast21’s device...
CooperCompanies acquires a selection of Cook Medical’s reproductive health products
CooperCompanies announced on November 1, 2023, the purchase of Cook Medical’s doppler monitoring, gynecology surgery, and obstetrics products for $300 million. CooperCompanies is a global medical device company that is...
FDA Clears Neurovalens’s Modius Sleep for Insomnia Treatment
Neurovalens successfully secured 510(k) clearance from the FDA on October 27, 2023 for its Modius Sleep device with relation to treatment of insomnia and/or anxiety. The clearance was supported by...
Cleerly Awarded Best Use of AI in Health Tech
Cleerly, a digital healthcare company offering artificial-intelligence-based software to identify and measure atherosclerosis from Coronary Computed Tomography Angiography (CCTA) imaging tests, was awarded Best in Class for the Best Use...
PREVAIL Act Proposes Significant Changes To PTAB Proceedings
IP rights can be vital to the success of medical device companies. Significant legislative changes governing some of these rights may be on the horizon. Senators Coons (Delaware), Durbin (Illinois), Hirono...
Updates in the FDA’s Regulation of Digital Health Technologies
The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software...
Enovis Corp. Acquires LimaCorporate for $846 Million
Enovis Corporation (“Enovis”) announced on September 25, 2023, that it has agreed to acquire LimaCorporate S.p.A (“LimaCorporate”). Enovis is a medical device company specializing in orthopedics. It offers a wide...
