More than two and a half years after the China Food and Drug Administration (CFDA) formally approved its first three-dimensional (3D) printed medical device for mass production, a hip implant co-developed by Peking University’s Third Hospital and AK Medical, the agency has issued a draft guidance on the regulatory requirements for approval of 3D printed devices.
On March 23, Auris Health, Inc. announced FDA clearance for the Monarch Platform, Auris’ new system for robotic endoscopy. According to Auris Health, the Monarch Platform “integrates the latest advancements in robotics, micro-instrumentation, endoscope design, sensing, and data science into one platform.”
According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform is the “first artificial intelligence triage software” and its approval begins “a new era of intelligent stroke care begins as regulatory approval.”
Before Newman, Mayer, and Stoll. Appeal from the U.S. District Court for the Northern District of Ohio.
Summary: While there is not a “practicing the prior art” defense to literal infringement, a litigant is not precluded from arguing that if a claim term is broadly construed to read on the accused product, then the same broad construction will read on the prior art.
According to PR Newswire, the Israeli Ministry of Health has granted initial approval to Tel-Aviv-based Kanabo Research for their VapePod vaporizer product as a medical device. PR Newswire notes that with this approval, Israel has become the first country in the world to grant medical device approval for a “vaporizer for the use of medical cannabis extracts and formulations.”
The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). According to an FDA news release, the approved test is the first direct-to-consumer test to report on three specific BRCA1 and BRCA2 breast cancer gene mutations.
The Supreme Court has issued two important decisions affecting Inter Partes Review (“IPR”) and other post-grant patent challenges conducted by the Patent Trial and Appeal Board (“PTAB”).
On March 22, 2018, a Texas federal court awarded patent infringement damages totaling over $8 million and ongoing royalties in a case involving multiple patents related to voice over IP technology. The damages award is based on a jury trial that was conducted in January 2016, where the jury found Metaswitch Networks liable for infringing Genband’s seven patents. During trial, Genband requested $9,076,000 in damages based on past sales.
Since May of 2016, Bayer and Monsanto have been working on a deal to combine the two giants. Based on a report released by the Wall Street Journal on Monday, April 9, 2018, the U.S. Department of Justice has just given its blessing to combine the companies.
