Talk about seller's remorse. Illumina spun out Grail in 2016, but last year the commpany declared its intentions to buy it back. Antitrust regulators in the United States and Europe scruitinized the deal, but Illumina thumbed its nose at them, saying it would complete the acquisition anyway, but keep the companies separate until FTC in the United States wrapped up its investigation. Now, both companies are facing hefty fines from the European Commission, which said that this is the first time two companies have openly implemented their deal during an open antitrust investigation, blatently ignoring the standstill obligation.
FDA released updated adverse report data on what is probably the most controversial birth control device ever sold. The agency has received close to 64,000 reports related to Essure, but it's difficult to know how many of those reports are duplicates of previously-submitted information. FDA has also received 86 reports claiming to link the device to a death (not counting the eight that appeared to be incorrectly coded as death reports), but the information submitted on those deaths are spotty, making it tough to determine if the deaths were truly caused by the birth control implant.
Siemens scored high praise from FDA this week after the agency cleared a device that uses the emerging CT imaging technology of photon-counting detectors, which can measure each individual X-ray that passes through a patient's body. Current systems use detectors that measure the total energy contained in many X-rays at once. By counting each individual X-ray photon, more detailed information about the patient can be obtained and used to create images with less information that is not useful in the review and analysis.
And in case you missed our last Medtech in a Minute report...
The Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has officially upheld most claims in the Medtronic patents that Axonics challenged, but this intellectual property feud is far from over. Axonics plans to appeal the PTAB’s decisions on the claims it declined to invalidate to the Director of the Patent & Trademark Office and to the U.S. Court of Appeals for the Federal Circuit. The PTAB’s decision only relates to the issue of invalidity or patentability of the Medtronic patents and does not mean that Axonics infringes any of the patents. Medtronic said it plans to ask the U.S. District Court in the Central District of California to lift the stay on the IP infringement case and resume proceedings. Axonics, however, said it expects the stay on legal proceedings to continue until the appeals process is complete.
GE Healthcare has agreed to acquire BK Medical for $1.45 billion. BK was a 2016 Medical Design Excellence Award finalist for its handheld ultrasound device designed to improve patient outcomes by enabling clinicians to achieve vascular access at first stick. That same year, however, the company shelled out a total of $14.9 million to settle a U.S. bribery probe when it was a subsidiary of Analogic.
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