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...
Haemonetics Corporation Acquires OpSens, Inc.
Haemonetics Corporation announced on October 10th that it would be acquiring OpSens, Inc. The deal between the companies is expected to close by the end of January 2024, according to...
Shutdown will Impact FDA
The looming government shutdown will likely slow the pace of work at the FDA. The federal government will shut down on October 1, 2023 unless a deal is reached. In the event...
Major Med Device Product Developer GE HealthCare Collaborating with Healthcare Providers
For good reasons, including product safety, quality assurance, development of delivery procedures and instructions, it has been a common practice for medical device companies and innovators to consult with physicians...
