Medical Devices > Nova Content
The U.S. Food and Drug Administration (FDA) published on February 23rd, 2022, a rule proposal to overhaul medical device quality control... Read More »
LARRY G. JUNKER V. MEDICAL COMPONENTS, INC.
Before Dyk, Reyna, and Stoll. Appeal from United States District Court for the Eastern District of Pennsylvania... Read More »
In addition to its significant efforts to fast track the approval of COVID-19 related devices, the FDA’s Center for Devices and Radiological Health (CDRH) has... Read More »
BLEPHEX, LLC. v. MYCO INDUSTRIES, INC.
Before: Moore, Schall, and O’Malley. Appeal from the Eastern District of Michigan.
Summary: Conclusory statements ... Read More »
Medtronic announced that its Intellis™ neurostimulator and the Vanta™ neurostimulator have both received approval from... Read More »
Surgeons at the University of Maryland School of Medicine performed the first successful porcine (pig) to human heart transplant, a procedure referred... Read More »
GE Healthcare announced on December 21, 2021, that it has completed the $1.45 billion acquisition of BK Medical from Altaris Capital... Read More »
On December 13, Baxter International Inc. (“Baxter”) announced the completion of one of the biggest medtech acquisitions of 2021... Read More »
(December 13, 2021) Two pharmaceutical companies have issued recalls in December due to manufacturing issues that may impact the safety and quality of their drug... Read More »
On December 1, 2021, RefleXion Medical, Inc. (“RefleXion”), announced that the U.S. Food and Drug Administration (“FDA”) has... Read More »
Try typing COVID in your search engines and you will likely get billions of results. Meanwhile a bit more than 2 years before, this and the coronavirus word were ... Read More »
Johnson & Johnson announced on November 12, 2021, that it is planning to separate its Consumer Health Business and create a new publicly traded Consumer... Read More »
Written by: Paige L. Cappelli
On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software... Read More »
Comments
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Nov 21, 2021
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Nov 21, 2021
Bioventus recently announced that its shareholders approved its agreement to acquire Misonix. Bioventus agrees to pay Misonix shareholders... Read More »
NeoChord, Inc. (“NeoChord”) announced on October 4, 2021 that it successfully completed a first-in-human procedure with the NeXuS Transcatheter... Read More »
The United States Department of Justice announced that medical device company Affordable Healthcare Solutions, LLC has pleaded guilty to charges related to... Read More »
Boston Scientific Corp. has agreed to acquire Devoro Medical Inc. in a deal expected to close this year. Boston Scientific previously held a 16%... Read More »
Baxter International Inc. (“Baxter”) has agreed to acquire Hillrom for $10.5 billion ($156 per share) in a deal expected to close in 2022. ... Read More »
The orthopedic industry traditionally sees significant levels of intellectual property litigation activity, and this year has been no different. One source of this... Read More »
According to an article published in Nature Biotechnology, Harvard and MIT researchers invented a face mask for detecting SARS-CoV-2, the virus... Read More »