Globus Medical announced early today that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017.
On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases, detailing proposals for streamlined development of certain antibacterial drugs.
The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017. This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA. Previously, companies had to submit a report within 30 days of a problem. Under the current version of the Reauthorization Act, companies will be able to submit reports once every three months instead. Additionally, these reports will be able to “summarize previously reported product malfunctions, rather than filing detailed reports on each case” as reported by the StarTribune. However, this does not affect the 30-day reporting requirement for medical device companies to report “adverse events” or anything that result in actual injury to consumers.
On August 3, 2017, a Boston jury awarded Philips $10.4 million in damages for ZOLL’s infringement of three patents relating to automated external defibrillators. This represents only a fraction of the $200 in damages that Philips was seeking at trial. Philips originally sued its competitor, ZOLL, in 2010 for infringement of fifteen of its patents.
On July 26, 2017, after eight years of litigation and multiple appeals, a Texas federal court ordered ION Geophysical Corporation (“ION”) to pay WesternGeco L.L.C. (“WesternGeco”) approximately $21 million in damages and an additional $5 million in enhanced damages for willful patent infringement.
The Federal Circuit determined that Article III standing was not necessary for an appellee to participate in a judicial appeal of an IPR final written decision because the appellant had Article III standing in Personal Audio, LLC v. Electronic Frontier Foundation, Case No. 2016-1123 (Fed. Cir. August 7, 2017).
On August 2, 2017, the U.S. Food and Drug Administration approved the use of Imbruvica® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) to Pharmacyclics LLC. Imbruvica® is the first FDA-approved therapy for the treatment of cGVHD.[1]
The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone with pending 510(k) submissions for devices that are now exempt “should withdraw their submissions.”
Hospira (owned by Pfizer) filed five IPR petitions against Genentech patents that Genentech asserted were directed to Herpceptin® (trastuzumab). The PTAB has now instituted IPRs in three of the five petitions and denied the other two.
On July 20, 2017, the Food and Drug Administration announced the clearance of “the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)” to Aspect Imaging Ltd.
