The U.S. Federal Trade Commission said it will block Illumina Inc., of San Francisco, from acquiring Pacific Biosciences Inc., of Menlo Park, Calif., due to the anticompetitive effect in next-generation sequencing. FTC said in a Dec. 17 statement that the proposed $1.2 billion acquisition would both eliminate current competition and suppress future competition, and that the agency will seek an injunction pending an administrative proceeding. The related administrative trial is scheduled for Aug. 18, 2020.
The Office of Inspector General at the U.S. Department of Health and Human Services said the Medicare program made $93.6 in excess payments to acute care hospitals as incentive payments under electronic health record (EHR) programs. That amount comes to less than 1% of the total $10.8 billion in incentive payments to these hospitals between January 2013 and September 2017, although a previous audit identified $729 million in excess payments. CMS agreed to pursue recovery of the excess payments.
The U.S. FDA said the class I recall of Cross Cath support catheters by Cook Medical Inc., of Bloomington, Ind., is due to a manufacturing error that renders the radiopaque bands either too loose or too tight, depending on the type of catheter. The problem can cause procedure time to increase, but the potential for separation of the band can cause loss of limb, stroke, or death. The FDA did not indicate that any complaints had been received. Cook is retrieving any unused inventory from the 117 devices in the recall, which were distributed between Sept. 3 and Sept. 19, 2019.
The FDA said the class I recall of the Giraffe incubators and omnibeds by GE Healthcare of Chicago is due to the potential for bedside panels to fail to latch, raising the risk of falls. No deaths have been reported, the FDA said, although six injuries, including skull fracture, hematoma and edema, have been reported. The company has provided updated closure instructions for the nearly 23,000 unites affected by the recall, which were distributed between April 2000 and September 2019.
The U.S. International Trade Commission (ITC) said it has received a complaint of patent infringement from Philips North America LLC, of Andover, Mass., and Royal Philips NV, alleging violation of Section 337 of the Tariff Act by Fitbit Inc., of San Francisco, and other parties, including Garmin International Inc., of Olathe, Kan. The complaint alleges infringement of wearable monitoring devices as well as systems and components thereof. The ITC seeks submissions of public opinion by Dec. 25.
The ITC also seeks public feedback in the patent infringement alleged by Theraject Inc., of Fremont, Calif., against several entities, including Raphas America Inc., of Wilmington, Del.; Ebay, of San Jose, Calif.; and Amazon, of Seattle. The articles in question are dissolving microneedle patches used in both drug delivery systems and in cosmetic procedures. The deadline for comment for this matter is also Dec. 25.
The Dec. 10 FDA warning letter to Conformis Inc., of Billerica, Mass., is a single-citation warning letter related to corrective action for sterility assurance for the company’s class II knee implants. The heavily redacted warning letter said that Conformis had identified corrective action for the use of a third party for preventive maintenance and repair of a redacted piece of equipment to reduce the incidence of an event that was also redacted. The company applied for a new 510(k) for the unidentified device, but the FDA said it is concerned that Conformis continues to manufacture the article with the existing sterility assurance program “instead of ensuring the process is operating under a validated state.”